The ICH guideline for stability testing - What matrixing does it permit?

Drug Information Journal

Volumn 32, Issue 2, 1998, Pages 561-567

  Pack, David J ^a  

^a SANOFI   (France)

Author keywords

Bracket designs; ICH guideline; Matrix designs; Stability; Statistical designs

Indexed keywords

DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL COOPERATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; STATISTICAL ANALYSIS;

EID: 0031750525     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159803200229     Document Type: Review

References (6)

1. International Conference on Harmonization Steering Committee. ICH Harmonized Tripartite Guideline -Stability Testing of New Drug Substances and Products. ICH; October 27, 1993.
2. Federal Register. 59 FR 48754: Docket No. 93D-0139; September 22, 1994.
3. US Food and Drug Administration. Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics. Rockville, Maryland: Center for Drugs and Biologics; 1987:23-38.
4. Fairweather WR. Design of Stability Studies: FDA Statistical Perspective. Arlington, VA: American Association of Pharmaceutical Scientists Workshop on Stability Guidelines for Testing Pharmaceutical Products: Issues and Alternatives II; March 1994.
5. Fairweather WR, Lin TD, Kelly R. Regulatory and Design Aspects of Complex Stability Studies. Washington, DC: Pharmaceutical Research and Manufacturers of America, Biostatistics Subsection/Clinical Data Management Group; October 1994.
6. Fairweather WR, Lin TD, Kelly R. Regulatory, design, and analysis aspects of complex stability studies. J Pharma Scis. 1995;84(11):1322-1326.