Publisher
Springer Science and Business Media LLC
Reference50 articles.
1. Yuvaneshwari K, Kollipara S, Ahmed T, Chachad S. Applications of PBPK/PBBM modeling in generic product development: an industry perspective. J Drug Del Sci Technol. 2022;69: 103152. https://doi.org/10.1016/j.jddst.2022.103152.
2. Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T. Physiologically based pharmacokinetics modeling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharm Res. 2023;40(2):337–57. https://doi.org/10.1007/s11095-022-03319-6.
3. Ahmed T, Kollipara S, Boddu R, Bhattiprolu AK. Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions. AAPS J. 2023;25(5):77. https://doi.org/10.1208/s12248-023-00837-y.
4. EMA Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation. (Accessed on 25th May 2024). Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-simulation_en.pdf
5. USFDA guidance on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry. (Accessed on 25th May 2024). Available from: https://www.fda.gov/media/142500/download\