如何利用非活性成分数据库并论证ANDA中的辅料安全性-Liu-Yang.pdf

1、How to Leverage the Inactive Ingredient Database and Justify Excipient Safety in ANDAsQing Liu,Ph.D.Office of BioequivalenceJulia Yang,PhDPharmacologist,Division of Pharmacology/Toxicology Review(DPTR)Office of Safety and Clinical Evaluation(OSCE)Office of Generic DrugsCDER|US FDA2025 Generic Drug F

2、orum April 9th,2025fda.gov/cdersbiafda.gov/cdersbia2This presentation reflects the views of the author and should not be construed to represent FDAs views or policies.Disclaimerfda.gov/cdersbiafda.gov/cdersbia3Overview:Part 1 IID introduction&use Limitations of IID IID mailbox and contact informatio

3、nfda.gov/cdersbiafda.gov/cdersbia4What is the IID&How to Use ItIID provides information on excipients present in FDA-approved drug products.*IID includes excipients in approved Abbreviated New Drug Applications(ANDAs)and New Drug Applications(NDAs).Excipients in approved Biologics License Applicatio

4、ns(BLAs)or Over the Counter(OTC)Monograph products are not included in the IID.*If an excipient is used in approved drug products for a particular route of administration,the excipient generally is not considered new and may warrant less extensive review the next time it is included in a new drug pr

5、oduct.*Can be accessed at:Inactive Ingredient Search for Approved Drug Products*Using the Inactive Ingredient Database Guidance for Industry|FDA fda.gov/cdersbiafda.gov/cdersbia5How to Use the IID Inactive Ingredient Search for Approved Drug Products(fda.gov)Enter any portion of the name of an excip

6、ient to search(enter at least three characters)fda.gov/cdersbiafda.gov/cdersbia6How to Use the IID(cont.)CAS=Chemical Service Abstracts Registry NumberUNII=Unique Ingredient Identifier assigned by FDAs Global Substance Registration System(GSRS)Flag for new recordsDisplays one row per unique Inactive