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

Course Description

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.

Who Should Attend

This three-day overview course is specifically designed for personnel in the pharmaceutical 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.

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.

Learning Objectives

Upon completing this course, participants will have a basic knowledge of the research studies conducted to characterize the likelihood of success for a drug candidate (either a small organic molecule (NCE) or macromolecule) after administration to animal models and humans.

Participants will learn about and understand the requirements for ADME, PK/TK, and DM studies conducted to select the optimal drug discovery lead (developability assessment), to support first-in-human clinical trials (preclinical studies) and to compare and extrapolate metabolism profiles from animal models to humans (nonclinical and clinical evaluations).

Past Participants' Comments

"Very good and comprehensive course. Extremely helpful overview of non clinical and preclinical component of the development process. Course materials were well-designed and will serve as a good resource for reference." Ella D., Associate Medical Director, J&J R&D

"This course was fantastic. Not only was it thorough and sufficiently detailed, the material was very well explained. I especially appreciated that the instructor actively encouraged questions and discussion, which made the class even more valuable. I appreciated the high level of energy (as well as knowledge) of the instructor. He provided many useful examples, which helped me to understand how to apply the information to real-world examples." Andrea S., Business Manager, Cancer Research Technology

"I found the course very beneficial. I do not work in the preclinical or clinical area. For me, I have heard some of this terminology in team meetings and wanted to become versed in the subject matter. I achieved this goal. This information will help me better connect my CMC/late development tasks with preclinical and clinical." Kerri Z., Sr. Scientist

"The instructor shared a lot of information which I found to be very valuable to me as a Regulatory person on the CMC side. His examples and evaluations are extremely helpful to me. Although I am not a pharmacist nor have clinical/nonclinical experience, the information is just enough for me to understand the discussion in project meetings." Carol P., Director of Regulatory Affairs, ENDO Pharmaceuticals

"The information was presented in a way where everyone will understand, whether they only have a basic understanding of PK or are in need of a refresher. Everything in the course came together and can assist these scientists who need an understanding of the whole aspect of pharmacokinetics. The course will definitely help me in my day to day work. I plan on keeping my binder and notes close to me at my desk to answer any questions I have during my daily work." Elizabeth H., Associate Scientist, J&J PRD

"This was an excellent course that exceeded my expectations. The breadth and depth of instruction was perfect for my personal needs. The instructor was highly knowledgeable and had extensive experience to draw from. Examples were effectively illustrated. The facilities were very good." Kathleen H., Study Delivery Director, AstraZeneca

Frequently Asked Questions

Is the course content too detailed for someone with no or only a limited understanding of pharmacokinetics and drug metabolism?

No, the course is designed as an overview course to provide information, with numerous examples, on the when, why, and how PK/TK, ADME, and DM studies are conducted to first select a discovery lead for development and then to characterize and develop that drug candidate into a therapeutic product.

Will information be provided on the nonclinical and clinical pharmacokinetic and drug metabolism studies required by the regulatory agencies?

The expectations of regulatory authorities with regards to PK/TK and drug metabolism studies will be discussed. However, the overall development program for each drug candidate is unique and thus the PK/TK and drug metabolism studies needed, and when those studies should be conducted, to successfully characterize a drug candidate are usually compound and disease indication specific.

Will pharmacokinetic and drug metabolism requirements for macromolecules be provided?

Yes, the nonclinical and clinical PK/TK and ADME studies needed to successfully characterize macromolecule drug candidates, such as proteins, will be discussed and examples of nonclinical and clinical PK studies on protein drug candidates will be provided.

Will discovery lead optimization studies be discussed?

Yes, many of PK, ADME, and DM studies commonly conducted during developability assessment or lead optimization to select a discovery lead for further development will be discussed and examples will be shared.

Does the course require detailed knowledge of mathematics, such as integral calculus, to understand the pharmacokinetics to be presented?

No, the course does provide a discussion on pharmacokinetic theory, how various PK parameter estimates are determined, and how these PK parameters are used to characterize the fate of a drug candidate in the body but this information is presented without using detailed mathematics.