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Clinical Pharmacokinetics

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01-03-2002 | Leading Article

The Product Label

How Pharmacokinetics and Pharmacodynamics Reach the Prescriber

Authors: Dr Patrick J. Marroum, Jogarao Gobburu

Published in: Clinical Pharmacokinetics | Issue 3/2002

Abstract

The product label, or package insert, is the ‘manual’ for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events.

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Title: The Product Label
How Pharmacokinetics and Pharmacodynamics Reach the Prescriber
Authors: Dr Patrick J. Marroum
Jogarao Gobburu
Publication date: 01-03-2002
Publisher: Springer International Publishing
Published in: Clinical Pharmacokinetics / Issue 3/2002
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI: https://doi.org/10.2165/00003088-200241030-00001

2024 ASCO Annual Meeting

Springer Medicine

The Product Label

How Pharmacokinetics and Pharmacodynamics Reach the Prescriber

Abstract

2024 ASCO Annual Meeting

Springer Medicine

Abstract

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