Intraluminal Behavior of Various Transporter Substrates in the Rat Gastrointestinal Tract
CONCLUSION: This study revealed that the luminal concentration pattern of each drug differed considerably depending on the site because of the different absorption properties and luminal volumes. Although further investigation using a specific transporter inhibitor or transporter-knockout animals are necessary to clarify the actual contribution of each transporter to the drug absorption, this information will be valuable in evaluating transporter-mediated drug absorption in in vitro transport studies for ensuring optimal drug concentrations.PMID:34826378 | DOI:10.18433/jpps32314 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - November 26, 2021 Category: Drugs & Pharmacology Authors: Yusuke Tanaka Taiki Harada Kazuhiro Ito Takanori Kurakazu Satoshi Kasaoka Source Type: research

Intraluminal Behavior of Various Transporter Substrates in the Rat Gastrointestinal Tract
CONCLUSION: This study revealed that the luminal concentration pattern of each drug differed considerably depending on the site because of the different absorption properties and luminal volumes. Although further investigation using a specific transporter inhibitor or transporter-knockout animals are necessary to clarify the actual contribution of each transporter to the drug absorption, this information will be valuable in evaluating transporter-mediated drug absorption in in vitro transport studies for ensuring optimal drug concentrations.PMID:34826378 | DOI:10.18433/jpps32314 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - November 26, 2021 Category: Drugs & Pharmacology Authors: Yusuke Tanaka Taiki Harada Kazuhiro Ito Takanori Kurakazu Satoshi Kasaoka Source Type: research

Intraluminal Behavior of Various Transporter Substrates in the Rat Gastrointestinal Tract
CONCLUSION: This study revealed that the luminal concentration pattern of each drug differed considerably depending on the site because of the different absorption properties and luminal volumes. Although further investigation using a specific transporter inhibitor or transporter-knockout animals are necessary to clarify the actual contribution of each transporter to the drug absorption, this information will be valuable in evaluating transporter-mediated drug absorption in in vitro transport studies for ensuring optimal drug concentrations.PMID:34826378 | DOI:10.18433/jpps32314 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - November 26, 2021 Category: Drugs & Pharmacology Authors: Yusuke Tanaka Taiki Harada Kazuhiro Ito Takanori Kurakazu Satoshi Kasaoka Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less s...
Source: J Pharm Pharm Sci - October 27, 2021 Category: Drugs & Pharmacology Authors: Matthias Shona Roost Henrike Potthast Chantal Walther Alfredo Garc ía-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodr íguez Martínez Andrew Tam Clare Rodrigues Diego Alejandro Gutierrez Triana Erwin Guzm Source Type: research

The Lymphatic System: A Sometimes-Forgotten Compartment in Pharmaceutical Sciences
J Pharm Pharm Sci. 2021;24:533-547. doi: 10.18433/jpps32222.ABSTRACTThe uniqueness of structure and physiology of the lymphatic system make it challenging to delineate all its contributions in the maintenance of our health. However, in the past two decades, the understanding of the importance of the function of this system has evolved and more appreciation has been drawn to the distinctive role it plays in health and disease. The lymphatic system has been linked to the pathophysiology of numerous ailments including cancer, various metabolic diseases, inflammatory conditions, and infections. Moreover, it has also been revea...
Source: J Pharm Pharm Sci - October 25, 2021 Category: Drugs & Pharmacology Authors: Malaz Yousef Daniela Silva Nadia Bou Chacra Neal Davies Raimar L öbenberg Source Type: research

The Lymphatic System: A Sometimes-Forgotten Compartment in Pharmaceutical Sciences
J Pharm Pharm Sci. 2021;24:533-547. doi: 10.18433/jpps32222.ABSTRACTThe uniqueness of structure and physiology of the lymphatic system make it challenging to delineate all its contributions in the maintenance of our health. However, in the past two decades, the understanding of the importance of the function of this system has evolved and more appreciation has been drawn to the distinctive role it plays in health and disease. The lymphatic system has been linked to the pathophysiology of numerous ailments including cancer, various metabolic diseases, inflammatory conditions, and infections. Moreover, it has also been revea...
Source: J Pharm Pharm Sci - October 25, 2021 Category: Drugs & Pharmacology Authors: Malaz Yousef Daniela Silva Nadia Bou Chacra Neal Davies Raimar L öbenberg Source Type: research

The Lymphatic System: A Sometimes-Forgotten Compartment in Pharmaceutical Sciences
J Pharm Pharm Sci. 2021;24:533-547. doi: 10.18433/jpps32222.ABSTRACTThe uniqueness of structure and physiology of the lymphatic system make it challenging to delineate all its contributions in the maintenance of our health. However, in the past two decades, the understanding of the importance of the function of this system has evolved and more appreciation has been drawn to the distinctive role it plays in health and disease. The lymphatic system has been linked to the pathophysiology of numerous ailments including cancer, various metabolic diseases, inflammatory conditions, and infections. Moreover, it has also been revea...
Source: J Pharm Pharm Sci - October 25, 2021 Category: Drugs & Pharmacology Authors: Malaz Yousef Daniela Silva Nadia Bou Chacra Neal Davies Raimar L öbenberg Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research

Analysis of Secondary Leukemia and Myelodysplastic Syndrome After Chemotherapy for Solid Organ Tumors Using the Food and Drug Administration Adverse Event Reporting System (FAERS)
CONCLUSIONS: Our study clarified the risks of leukemia and myelodysplastic syndrome for several anticancer drugs in patients with solid tumors. Our data may aid in the assessment of the risks of secondary leukemia and myelodysplastic syndrome when medical oncologists, clinical pharmacists, and patients select chemotherapy regimens.PMID:34644524 | DOI:10.18433/jpps31862 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Takehiro Kawashiri Daisuke Kobayashi Mayako Uchida Shiori Hiromoto Masashi Inoue Hajime Ikeda Mizuki Inoue Takao Shimazoe Source Type: research

A Nanoparticle Delivery of Plasmid Encoding Hepatocyte Growth Factor for Gene Therapy of Silicosis in Mice
CONCLUSION: Therefore, PEG-PEI/pHGF/HA nanoparticle warrant further investigation and may be a potential therapeutic strategy for silicosis.PMID:34644525 | DOI:10.18433/jpps32218 (Source: J Pharm Pharm Sci)
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Haiying Duan Peng Gao Xiaochen Cheng Yuxin Lu Chunsheng Hu Xuefeng Zhu Xiaoying Wang Dujuan Li Fengjun Xiao Li Du Yunmei Liu Qinglin Zhang Source Type: research

Solid Lipid Nanoparticles: An Approach to Improve Oral Drug Delivery
J Pharm Pharm Sci. 2021;24:509-532. doi: 10.18433/jpps31788.ABSTRACTNanoparticles have shown overall beneficial effects in drug administration. Specifically, solid lipid nanoparticles (SLN) have emerged as an alternative to polymer-based systems. However, the oral administration of SLN, the first choice for conventional medications, has not been addressed due to the taboo surrounding the complicated transit that this delivery route entails. This review focuses on the encapsulation of drugs into SLN as a strategy for improving oral administration. Examples of applications of SLN to enhance the absorption and bioavailability...
Source: J Pharm Pharm Sci - October 13, 2021 Category: Drugs & Pharmacology Authors: Nestor Mendoza-Mu ñoz Zaida Urb án-Morlán Gerardo Leyva-G ómez Mar ía de la Luz Zambrano-Zaragoza Elizabeth Pi ñón-Segundo David Quintanar-Guerrero Source Type: research