Decision Science for Generic Drug Development and Review
Author:
Affiliation:
1. Office of Generic DrugsCenter for Drug Evaluation and ResearchFood and Drug AdministrationSilver Spring MD USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.929
Cited by 4 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Bioequivalence Analysis of Terazosin Hydrochloride Tablets Based on Parallel Artificial Membrane Permeability Analysis;Pharmaceuticals;2024-08-05
2. Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence;Clinical Pharmacology & Therapeutics;2020-12-29
3. Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products;The AAPS Journal;2020-08-23
4. Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen;Journal of Pharmaceutical Sciences;2019-12
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