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

Author:

Boddu Rajkumar1,Kollipara Sivacharan1,Vijaywargi Gautam1,Ahmed Tausif1

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

Reference23 articles.

1. Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

2. Declaration of Helsinki 1964. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June and amended by the WMA General Assembly, Seoul, Korea, October 2008. https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf. Accessed 10th Jun 2023.

3. Prediction of ARA/PPI Drug-Drug Interactions at the Drug Discovery and Development Interface

4. EMA, Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation 2019. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-simulation_en.pdf. Accessed 10th Jun 2023.

5. Good Clinical Practices for Clinical Research in India 2013. Central drugs standard control organization. Ministry of Health and Family Welfare, Government of India. https://rgcb.res.in/documents/Good-Clinical-Practice-Guideline.pdf. Accessed 10th Jun 2023.

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