Stability Testing of New Drug Substances and Products

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... [Pg.284]

GL3 Stability 1 Stability testing of new drug substances and products... [Pg.132]

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Notice Stability testing of new drug substances and products Stability testing Stability testing... [Pg.76]

ICH Guidance for Industry Topic Q 1 A Stability testing of New Drug Substances and Products, 2003. [Pg.50]

ICH Harmonized Tripartite Guideline—Bracketing and Matrixing Designs for Stability Testing of New Drug Substance and Products QID, 2002. [Pg.358]

International Conference on Harmonization (ICH) (2003), Guidance for industry, Q1A (R2) stability testing of new drug substances and products, ICH, Brussels, Belgium. [Pg.556]

Grimm W. (1998), Extension of International Conference on Harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV, Drug Dev. Ind. Pharm., 24,313-325. [Pg.582]

Source. See ICH Draft Revised Guidance for Industry-QIA(R) Stability Testing of New Drug Substances and Products, April 2000, and FDA Draft Guidance for Industry-Stability Testing of Drug Substances and Drug Products, June 1998. [Pg.197]