Physiologically-based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Celia Ait-Chikh Guyl ène Page Vincent Thoreau Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically-based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Celia Ait-Chikh Guyl ène Page Vincent Thoreau Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Ait-Chikh Celia Page Guyl ène Thoreau Vincent Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Ait-Chikh Celia Page Guyl ène Thoreau Vincent Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Ait-Chikh Celia Page Guyl ène Thoreau Vincent Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Ait-Chikh Celia Page Guyl ène Thoreau Vincent Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Physiologically based pharmacokinetic models to predict drug exposure during pregnancy
Ann Pharm Fr. 2023 Sep 20:S0003-4509(23)00108-6. doi: 10.1016/j.pharma.2023.09.005. Online ahead of print.ABSTRACTAs pregnant women are constantly exposed to drugs during pregnancy, either to treat long-term conditions or acute illnesses, drug safety is a major concern for the fetus and the mother. Clinical trials are rarely made in this population due to strict regulation and ethical reasons. However, drug pharmacokinetic (PK) parameters vary during pregnancy with an increase in distribution volume, renal clearance and more. In addition, the fetal distribution should be evaluated with the importance of placental diffusion...
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Ait-Chikh Celia Page Guyl ène Thoreau Vincent Source Type: research
Greens Appraisal of Validated Stability Indicating RP-HPLC Method and Forced Degradation Study for Quantification of Ebastine in Wastewater and Dosage Form
CONCLUSION: According to International Council for Harmonisation (ICH) guidelines, a forced degradation study of EBS was evaluated, including acid, base hydrolysis, and oxidative hydrolysis using hydrogen peroxide and photolytic and thermal degradation. The highest degradation was achieved by acid hydrolysis. The safety and efficacy of EBS were evaluated via a safety comparative profile study.PMID:37739216 | DOI:10.1016/j.pharma.2023.09.004 (Source: Annales Pharmaceutiques Francaises)
Source: Annales Pharmaceutiques Francaises - September 22, 2023 Category: Drugs & Pharmacology Authors: Manal A Almalki Tahani Ya Alanazi Samar M Mahgoub Fatma I Abo El-Ela Mahmoud A Mohamed Source Type: research
Charge variants of proposed biosimilar to Omalizumab: Isolation, purification and analysis by HPLC methods
In this study, biosimilar product of Xolair was expressed in mammalian cell culture process in laboratory to isolate charge variants (acidic, main peak and basic). Different charge variants were isolated from intermediate purified biosimilar product of Xolair. Isolated charge variants were purified with preparative cation exchange chromatography technique and characterized with different analytical tools includes size exclusion chromatography (SEC-HPLC) and cation exchange chromatography (CEX-HPLC). Purity of acidic, main peak and basic variants was 99.58%, 99.98% and 98.64% respectively as per SEC-HPLC and according to CE...
Source: Annales Pharmaceutiques Francaises - September 14, 2023 Category: Drugs & Pharmacology Authors: Tarun Gupta Sriram Seshadri Source Type: research
