Pharmacokinetics and ADME Fundamentals

These flashcards provide essential vocabulary and definitions related to pharmacokinetics, pharmacodynamics, and their roles in the drug development process based on the lecture notes.

Pharmacokinetics (PK)

The study of a drug's distribution throughout the body that provides a mathematical basis to assess the time course of drugs and their cumulative systemic exposure.

ADME

An acronym representing the four quantified processes of Pharmacokinetics: Absorption, Distribution, Metabolism, and Excretion.

Pharmacodynamics (PD)

The study of the physiological effects of a drug and the pharmacologic reaction that takes place once the drug reaches its site of action.

Intrinsic factors

Patient-specific variables including age, weight, sex, and genetics that affect how medications are metabolized.

Lead optimization

The evaluation of promising drug candidates by assessing factors such as oral bioavailability, metabolic stability, and distribution characteristics.

Dose selection

Determining the appropriate dosage regimen for a drug using information provided by absorption, distribution, metabolism, and excretion (ADME).

Formulation development

The process of influencing drug design to improve bioavailability, stability, and patient compliance.

Drug-drug interaction

The effect caused when one drug affects the action or metabolism of another drug.

Clinical trial design

The planning of studies including dose-ranging, bioequivalence, and pharmacokinetics and pharmacodynamics modeling.

Regulatory approval

A necessary phase involving the FDA or other bodies to ensure the safety, efficacy, and quality of pharmaceutical products.

Post-marketing surveillance

The monitoring of real-world drug exposure, variability, and safety in larger patient populations after a drug has been approved.

Allucent

A leading PK science consulting group in the industry specialized in PK, PD, and clinical pharmacology.