Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications
Author:
Affiliation:
1. Biopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd, Integrated Product Development Organization (IPDO), Hyderabad, India
Funder
Dr. Reddy’s Laboratories Ltd
Publisher
Informa UK Limited
Subject
Health, Toxicology and Mutagenesis,Pharmacology,Toxicology,Biochemistry,General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/00498254.2023.2289160
Reference29 articles.
1. Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions
2. A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP
3. Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space
4. Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions
5. Declaration of Helsinki. 2008. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA general assembly Helsinki Finland June 1964 and amended by the WMA General Assembly Seoul Korea. [accessed 2023 Oct 01]. https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf
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