1. FDA-CRCG public workshop: best practices for utilizing modeling approaches to support generic product development, October 27-28, 2022, Virtual Workshop. Available from: https://www.complexgenerics.org/education-training/best-practices-for-utilizing-modeling-approaches-to-support-generic-product-development/. Accessed 10 Feb 2024.
2. Babiskin A, et al. Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: a workshop overview. CPT Pharmacomet Syst Pharmacol. 2023;12(5):619-623. https://doi.org/10.1002/psp4.12920.
3. Zhao L. What Is a model master file and how can it be shared? FDA-CRCG Public workshop: regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: regulatory utility of mechanistic modeling to support alternative bioequivalence approaches, September 30 and October 1, 2021, Virtual Workshop. Available from: https://www.complexgenerics.org/education-training/regulatory-utility-of-mechanistic-modeling-to-support-alternative-bioequivalence-approaches/. Accessed 10 Feb 2024.
4. Tsakalozou E, Babiskin A, Zhao L. Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: a case for diclofenac sodium topical gel, 1. CPT Pharmacometrics Syst Pharmacol. 2021;10(5):399–411.
5. Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA (August 2021). Available from: https://www.fda.gov/media/87219/download. Accessed 10 Feb 2024.