In general, clinical pharmacology studies are designed to gain understanding regarding the safety, pharmacokinetics (PK), pharmacodynamics (PD), drug interactions, and PK/PD in special populations of new chemical entities (NCEs) or biologics.
Part two of this clinical pharmacology 101 series covers clinical pharmacology strategy fundamentals including:
- Scope and significance
- Why we need clinical pharmacology studies
Meet the Speaker
David Y. Mitchell, PhD
Chief Scientific Officer
Dr. Mitchell has more than 28 years of leadership experience in clinical pharmacology and pharmacokinetics (PK). His focus is on strategic drug development, protocol design and planning, clinical and nonclinical data analysis/simulation/interpretation, and clinical pharmacology representation at regulatory meetings.