ADMET in Drug Development

Approximately one out of every 1,000 compounds identified in preclinical studies is eventually found suitable for human use. This creates a need to shorten the time and cost to increase the "hit" rate of finding drug candidates. This course will give you a comprehensive understanding of the biochemical aspects of drug metabolism in the drug discovery process and related pharmaceutical principles. Topics include pharmacokinetics, Phase I and II drug metabolism, factors affecting drug metabolism, and recent advances in drug metabolizing and absorption technology. The goal of this course is to...

Get an overview of the application of pharmacokinetic concepts to all stages of drug development. The focus will be on the practical application of pharmacokinetic principles in the design and conducting and interpreting preclinical and clinical pharmacokinetic studies. Areas to be covered will include pharmacokinetic concepts (absorption, distribution, metabolism, and elimination), pharmacodynamics, regulatory requirements, and guidance for in vitro and in vivo studies, and practical examples of preclinical and clinical pharmacokinetic and pharmacodynamic analyses. This entry-level course...

Gain a basic understanding of the introductory concepts and use of toxicology in drug discovery and development. The basic principles of toxicology will be presented as they relate to the assessment of drug safety from the initial selection of a drug for development through the registration of a drug for human use and post-marketing surveillance. The principles and applications of toxicology will be taught through the use of actual examples encountered in the drug discovery and development process to help you deal with toxicology issues you may encounter in the work environment. Chemists,...

Learn the process and considerations in predicting and selecting the most promising alternative among various candidate drug compounds. In a very practical way, this course applies the principles taught in previous courses related to the likelihood of positive absorption, distribution, metabolism, excretion and toxicology/patient safety outcomes of each compound. This course will include the use of in vitro studies utilized to predict in vivo outcomes in both test animals and humans

Discover the FDA regulatory requirements as they pertain to biotech and pharmaceutical companies. In this course, you will review topics such as: FDA organization and operations; U.S. Pharmacopoeial convention; INDs; the product development process; product characterization and pre-clinical evaluation; pharmacology/toxicology for new drugs and GLPs; clinical investigations, bioresearch monitoring and GCPs; and CMC requirements and GMPs. Also covered are the roles that regulatory affairs professionals play in the process.