包含比较临床终点研究的ANDA中常见的临床缺陷-Fan.pdf

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1、Common Clinical Deficiencies in ANDAs Containing Comparative Clinical Endpoint StudiesYing Fan,Ph.D.Team Leader,Division of Clinical Review,Office of Safety and Clinical Evaluation,Office of Generic DrugsCDER|US FDAGeneric Drug Forum April 10,2025fda.gov/cdersbiafda.gov/cdersbia2 Understand the goal

2、 and study design of a Comparative Clinical Endpoint Bioequivalence(CCEP BE)study and Irritation,Sensitization,and Adhesion(I/S/A)studies Get familiar with the common deficiencies in the CCEP BE study and I/S/A studies Be aware of the relevant guidances for the CCEP BE study and I/S/A studiesObjecti

3、vefda.gov/cdersbiafda.gov/cdersbia3Overview of Comparative Clinical Endpoint Bioequivalence(CCEP BE)Studyfda.gov/cdersbiafda.gov/cdersbia4What is a Generic?Same active ingredient,strength,dosage form,and route of administration,deliver identical amounts of the active ingredient over the identical do

4、sing period and meet the identical compendial or other applicable standard of identity,strength,quality and purity=Pharmaceutical Equivalents(PE)Absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of drug action=Bioequivalence(BE)Sa

5、me safety and efficacy when used in the indicated population according to the labeling recommendations=Therapeutic Equivalence(TE)Same Quality Standardshttps:/www.fda.gov/media/83670/downloadfda.gov/cdersbiafda.gov/cdersbia5Drug Price Competition and Patent Restoration Act(Hatch-Waxman Amendments)Ha

6、tch-Waxman Amendments:added section 505(j)to the Federal Food,Drug,and Cosmetic Act and established the modern system of generic drug regulation in United States(1984)There were three basic principles to generic drug approval provided by this act:generic approvals must be based on scientific conside