Assessment of shelf-life equivalence of pharmaceutical products

Chemical and Pharmaceutical Bulletin

Volumn 45, Issue 9, 1997, Pages 1482-1484

  Yoshioka, Sumie ^a   Aso, Yukio ^a   Kojima, Shigeo ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Range; Shelf life equivalent; Stability variation

Indexed keywords

ARTICLE; DRUG FORMULATION; DRUG PACKAGING; DRUG STABILITY; SHELF LIFE; STATISTICAL ANALYSIS; SYSTEM ANALYSIS; TECHNIQUE;

EID: 0030931911     PISSN: 00092363     EISSN: None     Source Type: Journal    
DOI: 10.1248/cpb.45.1482     Document Type: Article

References (4)

1. ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use) Harmonised Tripartite Guideline for Stability Testing of New Drug Substances and Products (October 1993).
2. Yoshioka S., Aso Y., Kojima S., LiWanPo A., Chem. Pharm. Bull., 44, 1948-1950 (1996).
3. Yoshioka S., Aso Y., Kojima S., Drug Stability, 1, 147-151 (1996).
4. Woolfe A. J., Worthington H. E. C., Drug Dev. Communication, 1, 185-210 (1974-1975).