Forced degradation studies during pharmaceutical development;Études de dégradation forcée au cours du développement pharmaceutique

S.T.P. Pharma Pratiques

Volumn 17, Issue 2, 2007, Pages 89-99

  Ellie, Colette ^b   Breton, David ^a   Brezillon, Carole ^b   Buret, David ^a   Camarade, Monique ^a   Castel, Frédéric ^c   Cosledan, Sylvie ^b   Coupe, Jérôme ^b   Crespo, Nicolas ^d   Duguet, Alain ^e   Laschi, Alda ^f   Laviron, Sylvie ^a   Menier, Isabelle ^g   Mennweg, Véronique ^h   Nolleau, Valérie ^a   Zanzi, Véronique ⁱ  

^a Pharmacie Centrale des Armées ^*  (United Kingdom)

^b INSTITUT DE RECHERCHE PIERRE FABRE   (France)

^c CARDINAL HEALTH   (United States)

^d IDD   (France)

^e SANOFI   (France)

^f SANOFI PASTEUR   (France)

^g Drugabilis   (France)

^h Laboratoire Fournier   (France)

ⁱ Galderma R and D   (France)

Author keywords

Active substances; Drug products; Forced degradation; Impurities; Pharmaceutical development; Stability; Stress; Validation

Indexed keywords

ANALYTIC METHOD; DEGRADATION KINETICS; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MONITORING; DRUG PACKAGING; DRUG STABILITY; HEAT STRESS; HUMIDITY; OXIDATIVE STRESS; PH MEASUREMENT; PHOTODEGRADATION; REVIEW;

EID: 34250712836     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. D.W. Reynolds et al. - Available guidance and best practices for conducting forced degradation studies. - Pharmaceutical Technology, February 2002.
2. K.M. Alsante et al. - A stress testing benchmarking study. - Pharmaceutical Technology, February 2003.
3. M. Kats - Forced degradation studies : regulatory considerations and implementation. - Biopharm International, 18, 7, 2005.
4. S. Singh, M. Bakshi - Guidance on conduct of stress tests to determine inherent stability of drugs. - Pharmaceutical Technology on-line, April 2000.
5. S. Klick et al. - Toward a generic approach for stress testing of drug substances and drug products. - Pharmaceutical Technology, February 2005.
6. Recommendation internationale - Échelle d'humidité relative de l'air par rapport à des solutions saturées de sels. - Organisation internationale de métrologie légale, OIML R 121, Ed. 1996.