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GUIDANCE DOCUMENT

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products January 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0164
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH guidance Q1A(R) Stability Testing of New Drug Substances and Products (the parent guidance).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0164.

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