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.
There are some tests which are commonly used to measure the quality and efficacy of the drug product, and these will be discussed. The discussion will focus on defining the appropriate procedures and establishing appropriate specification limits. The manufacture of sterile parenteral products includes the requirement of maintaining a higher requirement of safety for drug injection. There are some key factors involved in the testing for safety and how specifications will be determined.
Areas Covered in the Seminar: - ICH guidelines for procedure selection.
- ICH guidelines for specification establishment.
- Considerations for sterile drug products.
- Considerations for lyophilized drug products.
- Guidance for appropriate direction during early development phases.
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