Back to Resource Center

Q1A(R2) Stability Testing of New Drug Substances and Products

Q1A(R2) Stability Testing of New Drug Substances and Products

November 2003

Click to view Guidance Document

Click for full info +

Q1A(R2) Stability Testing of New Drug Substances and Products

November 2003
click to view Guidance Document
In this Technical Brief:
Product Type(s):

  • New Drug Substances and Products
Topic(s):

  • Stability Testing
  • Q1A (R2)
Region(s):

  • United States

Full Info:


Resource Type:

Guidance Document

Citation:

U.S. Department of Health and Human Services, Food and Drug Administration

Authors: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research

Health Risks(s):

  • HIV
  • STI / STD
  • Unintended Pregnancy

Product type(s):

  • MPTs

Topic(s):

  • Development
  • Regulatory

Region(s)

  • United States

URL of resource:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products

Back to Resource Center