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Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development
This article is protected by copyright. All rights reserved.PMID:38093583 | DOI:10.1002/cpt.3150 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - December 14, 2023 Category: Drugs & Pharmacology Authors: John D Davis Mar çal Bravo Padros Daniela J Conrado Samit Ganguly Xiaowen Guan Hazem E Hassan Anasuya Hazra Susan C Irvin Priya Jayachandran Matthew P Kosloski Kuan-Ju Lin Kamalika Mukherjee Anne Paccaly Apostolos Papachristos Michael A Partridge Saileta Source Type: research

Implications of Incorporating Plasma Lipoprotein Binding into a Physiologically-Based Pharmacokinetic Model: A Simulation Study with Amiodarone
This study demonstrates that incorporating plasma lipoprotein binding into a PBPK model improves the accuracy of predicting interindividual variabilities in amiodarone clearance by more reliably predicting the interindividual variability in the plasma unbound fraction of amiodarone. Plasma lipoprotein binding should be considered in PBPK modeling and simulations for lipoprotein-associated drugs if there is available information on the relationship between plasma lipoprotein binding and hyperlipidemia.PMID:38093601 | DOI:10.1002/cpt.3149 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - December 14, 2023 Category: Drugs & Pharmacology Authors: Kosuke Doki Naoaki Hashimoto Keigo Yoshida Masato Homma Source Type: research

Impact of Pregnancy on the Pharmacokinetics and Metabolism of Nicotinamide in Humans
Clin Pharmacol Ther. 2023 Dec 13. doi: 10.1002/cpt.3146. Online ahead of print.ABSTRACTIn preeclampsia models, nicotinamide (NAM) has protective effects in preeclampsia and is being evaluated as a therapeutic nutraceutical in clinical studies. NAM undergoes extensive hepatic metabolism by NAM N-methyltransferase to methylnicotinamide (MNA), which is subsequently metabolized to methyl-2-pyridone-5-carboxamide (M2PY) by aldehyde oxidase. However, the pharmacokinetics (PK) of NAM and its major metabolites has never been studied in pregnant individuals. Blood samples were collected before and 1, 2, 4, 8, and 24 hr after single...
Source: Clinical Pharmacology and Therapeutics - December 14, 2023 Category: Drugs & Pharmacology Authors: Muluneh M Fashe Tien V Le Megan N Gower Ian R Mulrenin Karen F Dorman Spenser Smith John K Fallon Julie B Dumond Kim A Boggess Craig R Lee Source Type: research

Reply to "Capturing synergy holistically in psychedelic clinical trials"
Clin Pharmacol Ther. 2023 Dec 13. doi: 10.1002/cpt.3130. Online ahead of print.NO ABSTRACTPMID:38087954 | DOI:10.1002/cpt.3130 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - December 13, 2023 Category: Drugs & Pharmacology Authors: Robert H Dworkin Michael P McDermott Sandeep M Nayak Eric C Strain Source Type: research

Current Perspectives on Data Sharing and Open Science in Pharmacogenomics
Clin Pharmacol Ther. 2023 Dec 13. doi: 10.1002/cpt.3115. Online ahead of print.NO ABSTRACTPMID:38087986 | DOI:10.1002/cpt.3115 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - December 13, 2023 Category: Drugs & Pharmacology Authors: Deanne Nixie R Miao Feryal Ladha Sarah M Lyle Daniel W Olivier Samah Ahmed Britt I Dr ögemöller Source Type: research

Animal-to-Human Dose Translation of ANTHRASIL for Treatment of Inhalational Anthrax in Healthy Adults, Obese Adults, and Pediatric Subjects
Clin Pharmacol Ther. 2023 Dec 11. doi: 10.1002/cpt.3097. Online ahead of print.ABSTRACTAnthrax Immune Globulin Intravenous (AIGIV [ANTHRASIL]), was developed for the treatment of toxemia associated with inhalational anthrax. It is a plasma product collected from individuals vaccinated with anthrax vaccine and contains antitoxin IgG antibodies against Bacillus anthracis protective antigen. A pharmacokinetic (PK) and exposure-response model was constructed to assess the PKs of AIGIV in anthrax-free and anthrax-exposed rabbits, non-human primates and anthrax-free humans, as well as the relationship between AIGIV exposure and ...
Source: Clinical Pharmacology and Therapeutics - December 12, 2023 Category: Drugs & Pharmacology Authors: Martin Beliveau Igor Rubets Drobic Bojan Christine Hall Derek Toth Shantha Kodihalli Srinivas Kammanadiminti Source Type: research

Super-responder and clinical remission in patients with asthma on treatment with single biologic therapy or cycling therapy using dupilumab in a real-world setting
CONCLUSION: This study identified the percentage and features of patients on treatment with dupilumab showing SR and CR in a real-world setting. The outcome beyond CR on biologic treatment should be clarified.PMID:38085095 | DOI:10.5414/CP204495 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - December 12, 2023 Category: Drugs & Pharmacology Authors: Satoshi Hamada Eriko Ogino Hirotaka Yasuba Source Type: research