What is rechallenge in pharmacovigilance?
Rechallenge – This refers to the restarting of the same drug after having stopped it, usually for an AE. Rechallenges may also be complete or partial. Thus the patient may have restarted ampicillin a week later after having stopped it. A positive rechallenge – This refers to the AE recurring after restarting the drug.
What is co suspect drug?
a medication which when prescribed with another one causes an adverse event.
What is safety data generation process?
Clinical Trial Safety Data Generation Reporting timelines: Any Serious, unexpected or life threatening adverse events must be reported within 7 days Any other unexpected AEs that are neither fatal not life threatening should be reported within 15 days. Post Marketing Safety Data Generation 27.
What is meant by rechallenge?
transitive verb. : to challenge again But now a new breed of independent store is beginning to rechallenge the chains and discount online retailers.—
What is a rechallenge study?
Challenge–dechallenge–rechallenge (CDR) is a medical testing protocol in which a medicine or drug is administered, withdrawn, then re-administered, while being monitored for adverse effects at each stage.
What is concomitant use?
From Wikipedia, the free encyclopedia. Concomitant drugs are two or more drugs used or given at or almost at the same time (one after the other, on the same day, etc.). The term has two contextual uses: as used in medicine or as used in drug abuse.
What is main purpose of PVPI?
The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.
What are ICH guidelines for pharmacovigilance?
The following principles underpin this guideline: • Planning of pharmacovigilance activities throughout the product life-cycle; • Science-based approach to risk documentation; • Effective collaboration between regulators and industry; • Applicability of the Pharmacovigilance Plan across the three ICH regions.