News

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Parexel announces PAREXEL® Access, a service that is directed toward clients’ market access and ongoing commercial success.

CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.

This scenario seeks to limit animal and clinical studies to only those needed to eliminate residual uncertainty about product performance. Although innovators maintain that clinical trials still are needed to fully examine immunogenicity and other unique attributes of proteins and monoclonal antibodies, biosimilar developers look to extensive product characterization and to pharmacokinetic (PK) or pharmacodynamic (PD) studies to address these concerns.