Pharmaceutical Technology-02-01-2003

Stability studies are essential to every phase of a drug's life cycle. They not only document that a product will maintain its potency during its stated shelf life, but that it will do so under a variety of storage conditions as well.

Selection of a contract research organization is a decision that encompasses many key factors. In this article, the author discusses various considerations that surface when selecting and working with a CRO and provides tips for establishing a beneficial relationship.

Raw materials testing ensures that the raw materials used in pharmaceutical products are suitable for their intended use. Conducting raw materials analysis using appropriate test methods and successfully meeting the challenges of such testing can prevent costly production problems and delays.

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.