Potency determination of drugs and biologics: design, and development of reliable potency bioassays
Venue: Online Event
|Event Date/Time: May 26, 2010||End Date/Time: May 26, 2010|
Potency of all drugs and biologics is a requisite characteristic of pre-clinical and clinical grade materials for regulatory agencies. In some cases, the detailed mechanism of action of many drugs and biologics are either relatively obscure or under investigation, and obviate the protective attributes of the drug candidate. Therefore, potency measurements are considered a reliable indicator of therapeutic potential and also an indicator of physio-chemical and immunological integrity of a therapeutic candidate during product release and stability testing. The methods and optimization of potency assays can evolve during phases of drug development, and in conjunction with an accruing scientific and clinical knowledge-base on the targeted disease condition, and the therapeutic candidate.
This webinar will provide a comprehensive overview of potency. The design and development of assays to measure potency, key validation parameters, and specifications will be addressed. Problems due to method variability, the impact on accuracy of potency measurements, and relevant case studies will be discussed. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.