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ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
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The content of this overview course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines.

5/18/2015 to 5/20/2015
When: May 18-20, 2015
Where: Desmond Hotel and Conference Center
Malvern, Pennsylvania 
United States
Presenter: The Center for Professional Innovation and Innovation
Contact: 855.752.9320

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ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development

The content of this overview course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed.

Study designs and potential results along with possible interpretations from each of the study types will be presented. The generation study reports and summaries, both of which are to be included in submissions to regulatory authorities for completed research experiments, will also be discussed.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.


 

 

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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