Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
https://link.springer.com/content/pdf/10.1208/s12248-023-00879-2.pdf
Reference24 articles.
1. Zhao L, Kim MJ, Zhang L, Lionberger R. Generating model integrated evidence for generic drug development and assessment. Clin Pharmacol Ther. 2019;105(2):338–49.
2. Lionberger RA. Innovation for generic drugs: Science and research under the generic drug user fee amendments of 2012. Clin Pharmacol Ther. 2019;105(4):878–85.
3. United States Congress. H.R.6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. 2022.
4. Tsakalozou E, Alam K, Babiskin A, Zhao L. Physiologically-based pharmacokinetic modeling to support determination of bioequivalence for dermatological drug products: Scientific and regulatory considerations. Clin Pharmacol Ther. 2022;111(5):1036–49.
5. Zhao L, Seo P, Lionberger R. Current scientific considerations to verify physiologically-based pharmacokinetic models and their implications for locally acting products. CPT: Pharmacomet Syst Pharmacol. 2019;8(6):347.
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