Bringing a New Drug to Market

Presented by

Kirk Mousley

This training seminar is an introduction to the drug development process. It is intended for all professionals working in or intending to work in the pharmaceutical industry. Below is a list of the topics covered in the talk.

 Drug Development Initiation

...the reasons why companies develop drugs.

Conjuring up the compounds

...the discovery of potential drug substances.

Producing the compound

...the process of producing enough drug substance to run tests and clinical trials.

Pre-clinical (Non-clinical)/in vitro

...initial testing in test tubes and petri dishes to determine the viability of the substance.

Pre-clinical (Non-clinical)/in vivo

...animal testing performed to verify the substance’s pharmacology, pathology, and toxicology.

Investigational New Drug Application

...the FDA requirements for permission to use the substance in human testing.

Clinical Trials

...the four phases of clinical trials. What are they and what do they accomplish.

Submission/NDA

...the FDA requirements for obtaining approval to market the drug.

Large scale manufacturing

...the process development effort to scale up production to meet marketing demands.

Marketing

...the actual selling of the drug substance.

Post Marketing

...additional testing and clinical trials on marketed drug substances to expand the use of the drug.

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