The product label: how pharmacokinetics and pharmacodynamics reach the prescriber

Clinical Pharmacokinetics
P J Marroum, Jogarao Gobburu

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.

References

Aug 3, 1999·Clinical Pharmacology and Therapeutics·R YuanP Marroum

❮ Previous
Next ❯

Citations

Dec 16, 2004·European Journal of Clinical Pharmacology·Meret Martin-FacklamWalter E Haefeli
Jan 29, 2013·Journal of Biomedical Semantics·Richard D BoyceMaria Liakata
Dec 24, 2003·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Hisashi IijimaMakoto Shiragami
Sep 6, 2005·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Hisashi IijimaMakoto Shiragami
Feb 12, 2010·American Journal of Public Health·Angelica P HerreraArmin D Weinberg
Aug 7, 2007·IEEE Transactions on Information Technology in Biomedicine : a Publication of the IEEE Engineering in Medicine and Biology Society·Richard D BoyceIra Kalet
Oct 5, 2019·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Megumi Watanabe-UchidaMamoru Narukawa
Nov 2, 2013·Nuclear Medicine Communications·Federica E BuroniCarlo Aprile

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
Lisa E HinesD C Malone
© 2022 Meta ULC. All rights reserved