Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

This pharmaceutical manufacturing training 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.

Who Should Attend

Those attending this training should have some knowledge of the aforementioned processes, as well as, a desire to learn more about how ADME, PK/TK, and DM studies are designed, conducted, and interpreted in order to characterize the fate of a drug candidate in the body. Nonclinical and clinical scientists, managers, and project team leaders at pharmaceutical companies and related industries will gain a basic understanding of the types of ADME, PK/TK, and DM research studies conducted to support submissions to regulatory authorities.

This three-day overview course is specifically designed for personnel in the pharmaceutical manufacturing and biotechnology industries, as well as, contract research organizations (CROs) who need to understand the requirements for ADME (absorption, distribution, metabolism, elimination), pharmacokinetics (PK) and toxicokinetics (TK), and drug metabolism (DM) experiments during the drug discovery and the preclinical/nonclinical and clinical development processes.

Duane B. Lakings, Ph.D.

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.