Dissolution test acceptance sampling plans
Author:
Affiliation:
1. a Division of Biometrics, HFD-710 ,
2. b Division of Biopharmaceutics HFD-423 , Center for Drug Evaluation and Research U.S. Food and Drug Administration , 5600 Fishers Lane, Rockville, Maryland, 20857
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543409508835106
Reference11 articles.
1. Pharmaceutical Dissolution Testing
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1. Drug product performance and scale-up process approval changes;Regulatory Affairs in the Pharmaceutical Industry;2022
2. Bootstrap confidence intervals for dissolution similarity factor f2;Biometrics & Biostatistics International Journal;2018-09-18
3. Dissolution Curve Comparisons Through theF2Parameter, a Bayesian Extension of thef2Statistic;Journal of Biopharmaceutical Statistics;2014-10-30
4. Sampling Considerations;Sample Preparation of Pharmaceutical Dosage Forms;2011
5. A new principal component analysis-based approach for testing “similarity” of drug dissolution profiles;European Journal of Pharmaceutical Sciences;2008-05
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