Abstract
During the life of a drug product, it is almost certain that at some point, changes will be made, for example to the manufacturing process, the API material, or the formulation. For each change, it is necessary to demonstrate the acceptability of the proposed change, in order to prove that the specified change does not have an adverse effect on the product. The type of change will determine what type of stability data will be required to support it and to understand the impact on the stability profile of the drug product. An appropriate stability design must be developed to understand the impact of the change on the stability profile of the drug product and to demonstrate the acceptability of the proposed change. The type of change will dictate the amount of data needed and the type of regulatory reporting required. Guidance documents provide direction on the reporting category for different types of changes. For a proposed study design or data package that is different from the guidance documents, it is best to discuss the proposal with the regulatory agency first to obtain their opinion. This presentation will review the various reporting categories and provide stability strategies to support some specific types of changes, including some case examples of stability designs that have been conducted.
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- 1.
Guidance for Industry: Changes to an Approved NDA or ANDA, CDER April 2004.
- 2.
ICH Guideline: Guidance for Industry Q5E Comparability of Biotechnological/ Biological Products Subject to Changes in their Manufacturing Process.
- 3.
ICH Guideline: Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products.
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© 2010 American Association of Pharmaceutical Scientists
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Webb, P.J.Y. (2010). Maximize Data for Post Approval Changes. In: Huynh-Ba, K. (eds) Pharmaceutical Stability Testing to Support Global Markets. Biotechnology: Pharmaceutical Aspects, vol XII. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0889-6_24
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DOI: https://doi.org/10.1007/978-1-4419-0889-6_24
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