Stability studies

Separation Science and Technology

Volumn 3, Issue C, 2001, Pages 445-483

  Cha, Jessica ^a   Ranweiler, Joseph S ^a   Lane, Philip A ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79959565230     PISSN: 18771718     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0149-6395(01)80015-5     Document Type: Chapter

References (14)

1. QIA(R): Stability Testing of New Drugs and Products (Revised Guideline), International Conference on Harmonisation, issued October 1999.
2. Stability Testing of Drug Substances and Drug Products (Draft Guidelines), Food and Drug Administration, issued June 1998.
3. USP 24-NF 19, United States Pharmacopeial Convention, Inc., Rockville, MD, 2000.
4. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, Vol. 2: Good Manufacturing Practices and Inspection. World Health Organization, Geneva, 1999.
5. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, Vol. 1. World Health Organization, Geneva, 1997.
6. Grimm, W. Drug Dev. Ind. Pharm. 19:2795-2830, 1993.
7. Cloud, P. A. BioPharm Nov:30-42, 1997.
8. United States v. Barr Laboratories, Inc. Civil Action No. 92-1744, U.S. District Court for the District of New Jersey; 812 F. Supp. 458; 1993 U.S. Dist. Lexis 1932; 4 February 1993, as amended 30 March 1993.
9. Excipient Biological Safety Evaluation Guidelines, General Chapter <1074>, and Excipients: USP and NF Excipients, Listed by Categories, pp. 2404-2406, in USP 24-NF 19. U.S. Pharmacopeil Convention, Rockville, MD, 2000.
10. The Merck Index, Eleventh Edition, item 4856. Merck &C Company, Rahway, NJ, 1989.
11. Carstensen, J. T. Pharmaceutics of solids and solid dosage forms. Chap. VII-2, 1977.
12. QIA(R): Stability Testing of New Drug Substances and Products (Draft, Revised Guidance), Food and Drug Administration, issued April 2000.
13. Reviewer Guidance, Validation of Chromatographic Methods, Food and Drug Administration, issued November 1994.
14. Container Closure Systems for Packaging Human Drugs and Biologies, Food and Drug Administration, issued May 1999.