Clinical Pharmacokinetic Studies in Drug Development

I wanted to compile a list of various PK studies conducted during the course of drug development. Several studies are conducted in the early phase of clinical development to understand the pharmacokinetics (PK) of a new drug in healthy human volunteers and/or patients. The objective of such PK studies is to evaluate the absorption, distribution, metabolism and excretion (ADME) of a new drug in humans.

Information gathered during these studies include PK parameters such as area under the curve (AUC, exposure), Cmax (maximum concentration) , Tmax (Time to Cmax), half life, clearance, volume of distribution, bioavailability, steady state plasma concentrations, accumulation ratio, linear or nonlinear PK, time dependent PK (auto-induction), plasma protein binding, metabolite identity and their PK.

Here goes the list.

1. Single Ascending Dose (SAD)
2. Multiple Ascending Dose (MAD)
3. Food Effect Studies
4. ADME Mass Balance Studies
5. Absolute/Relative Bioavailability
6. Thorough QTc Study
7. Drug Interaction Studies - Enzyme Inhibition/Induction
8. Effect of Age and Gender
9. Special Population - Hepatic Impairment
10. Special Populaiton - Renal Impairment
11. Impact of Genetic Polymorphisms of Drug Metabolizing Enzymes

I will be blogging on each of these topics in the next few weeks. I am quite keen to know how modeling & simulation approaches have been used in early clinical PK studies. Feel free to share your thoughts/comments, any unusual experiences in the conduct of these studies.