AAPS Workshop on Clinical Pharmacology and ADME of Biotherapeutic Proteins

  • Date: 05-19-2012 -- 05-20-2012
  • Type: Workshop
  • CE Available?: Yes
  • Exhibit Available?: No
  • Posters Available?: No
  • Location: Sheraton San Diego Hotel and Marina, San Diego
  • Description/Summary: This workshop will provide the current best practices in Clinical Pharmacology of Biotherapeutic proteins by experts from industry, academia, and regulatory colleagues and discuss challenges we are facing. The emphasis will be on monoclonal antibodies and antibody-drug conjugates and cover topics such as FIH study design, QT assessment, pharmacokinetic characterization, bioanalytical assays, therapeutic protein-drug interactions, QT risk assessment, and immunogenicity testing. Additionally, traditional clinical pharmacology aspects including special populations (Paediatrics, Hepatic and renal impairment) and ADME characterization will be reviewed, as well as regulatory expectations in this area. 
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  • Telephone: +1.703.243.2800
  • Fax: +1.703.243.5582
  • URL: ClinPharm