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

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

November 2003

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

November 2003
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

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