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

 
  July 09, 2014  
     
 
Center for Professional Innovation & Education, Inc., Berlin, Germany
Nov. 3 – 5, 2014


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.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Duane B. Lakings, Ph.D., is the Principal and President of Drug Safety Evaluation Consulting, Inc. DSE Consulting assists pharmaceutical and biotechnology companies in designing, conducting, and interpreting results from experiments for characterizing and developing drug candidates into therapeutic products. Dr. Lakings has over 25 years of experience in drug discovery and developability assessment, preclinical and nonclinical development, and clinical development and has designed and conducted animal and human research studies on both small organic molecules and macromolecules.

His primary areas of expertise include pharmacokinetics and toxicokinetics, drug metabolism and ADME, drug delivery, and bioanalytical chemistry and he has excellent knowledge of the pharmacology, toxicology, and clinical requirement for successful drug development. During his career, he has been involved in characterizing drug candidates for a number of therapeutic diseases and disorders, including CNS, cardiovascular, metabolic diseases, oncology, infectious diseases (bacterial and viral), and dermatology. Since opening DSE Consulting, he has used his knowledge to assist clients with defining drug development logic plans, selecting and managing CROs, and preparing study reports for completed nonclinical and clinical research studies.

 
Deadline for Abstracts: n/a
 
Registration: click here to register
E-mail: info@cfpie.com
 
   
 
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