Consideration on a few aspects of the stability studies post licensure.
Stability studies represent a significant workload for both manufacturers and regulatory reviewers and therefore a careful selection of the study design and of the stability indicator test is required to make sure that the study will provide the relevant information. Moreover, alternatives to the existing regulatory approaches should be favoured in order to better or quicker analyze the impact of a specific change. In this article, examples of alternative approaches are given. For the stability monitoring study, emphasis is put on the bulk stability program. Concerning comparability stability study, two case studies illustrating how accelerated stability studies could be used to support manufacturing changes are presented.
Pierard
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GlaxoSmithKline Biologicals, Rixensart, Belgium. isabelle.pierard@gskbio.com
Spelte
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G
Le Tallec
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D
Duchêne
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M
D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000379:methods; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000379:methods*; D004355:Drug Stability; D005612:Freeze Drying / Q000379:methods / Q000592:standards; D006801:Humans; D008009:Licensure, Pharmacy; D014612:Vaccines / Q000493:pharmacokinetics* / Q000592:standards; D054928:Validation Studies as Topic
D014612:Vaccines