Extension of the international conference on harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV

Drug Development and Industrial Pharmacy

Volumn 24, Issue 4, 1998, Pages 313-325

  Grimm, Wolfgang ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; ATMOSPHERIC PRESSURE; COLD CLIMATE; DESERT CLIMATE; DRUG LABELING; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; ENVIRONMENTAL TEMPERATURE; GOOD MANUFACTURING PRACTICE; HUMIDITY; STANDARD; TROPIC CLIMATE;

EID: 0031954253     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.3109/03639049809085626     Document Type: Article

References (8)

1. N. Futscher and P. Schumacher, Pharm. Ind., 34, 479-483(1972).
2. W. Grimm and K. Krummen, Stability Testing in the EC, Japan and the USA. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 1993.
3. W. Grimm, Drugs Made in Germany, 28, 196-202 (1985) and 29, 39-47(1986).
4. W. Grimm, Drugs Made in Germany, 28, 196-202 (1985) and 29, 39-47(1986).
5. R. Dietz, K. Feilner, F. Gerst, and W. Grimm, Drugs Made in Germany, 36, 99-103 (1993).
6. W. Grimm, Storage conditions for the most important market for drug products, including the EG, Japan and the USA; Drug Dev. Ind. Pharm., 19, 2795-2830 (1993).
7. J. D. Haynes, J. Pharm. Sci., 60, 927-929 (1971).
8. E. Spingier, Verpackungs-Rundschau, 3, 17-21 (1974).