Stability Program Management,
Clinical Trial Materials

PTC When Using A Contract Stability Lab

A white paper by Alexander Mello & Jessica Labrie of Microtest Labs.

Much more than just regurgitating the ICH guidelines, this paper focuses on the start-up and set-up of a stability program when it must be outsourced to a third-party laboratory. The discussion centers on the following key issues:

Initial communications with the contract stability organization
Transfer of methods
Required product knowledge and program management
Data presentation for important decision making on label claims

The authors review the development of a parenteral stability program from the standpoint of effective program management — not from the regulatory or scientific requirements approach covered extensively by most other stability white papers.

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Stability Program Management, Clinical Trial Materials

PTC When Using A Contract Stability Lab

A white paper by Alexander Mello & Jessica Labrie of Microtest Labs.

Stability Program Management,
Clinical Trial Materials