Related Experiment Video
Updated: Aug 8, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
Postmarketing surveillance: curriculum for the clinical pharmacologist. Part II: Clinical and regulatory
1Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, Maryland 20857.
Abstract:
This is the second of a two-part series that develops a curriculum on postmarketing surveillance. With the ongoing emphasis on drug safety and possible earlier marketing of drugs, this becomes an essential element of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a specific drug or drug class, perhaps in the context of clinical trial study design and analysis. This curriculum complements this approach and provides an overview of drug safety surveillance from regulatory and epidemiologic perspectives.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Preclinical Development: Overview
Dosage Regimens: Designs and Approaches
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

