Laboratory Compliance 2011 - Designing appropriate product specifications for lyophilized parenteral products

Why Should You Attend:

During the early phases of drug and formulation development, discovery regarding the quality attributes of a new drug substance or a new drug product emerge. Setting specifications is a critical part of the development, as this ultimately defines how a drug product can be considered, safe, effective and of an appropriate quality.

Lyophilized products to be used for injection have some typical requirements for appropriate testing. The appropriate tests are based upon determining the quality and efficacy of the drug, which is impacted not only by the manufacturing process but also by the physical changes which take place via lyophilization.

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