Young, Graeme C, Spracklin, Douglas K, James, Alexander David, Hvenegaard, Mette G, Pedersen, Mette L, Wagner, David S, Georgi, Katrin, Schieferstein, Hanno, Bjornsdottir, Inga, Romeo, Andrea A, Cassidy, Kenneth C, Da-Violante, Georges, Blech, Stefan, Hoffman, Matthew, Schulz, Simone I, Cuyckens, Filip, Nguyen, Mai Anh and Scarfe, Graeme (2023) Non-labelled, Stable Labelled or Radiolabelled Approaches for Provision of Intravenous Pharmacokinetics in Humans: a Discussion Piece. Clinical pharmacology and therapeutics. ISSN 1532-6535

Abstract

A review of the use of microdoses and isotopic microtracers for clinical intravenous pharmacokinetic (IV PK) data provision is presented. The extent of application of the varied approaches available and the relative merits of each are highlighted with the aim of assisting practitioners in making informed decisions on the most scientifically appropriate design to adopt for any given new drug in development. It is envisaged that significant efficiencies will be realized as IV PK data in humans becomes more routinely available for suitable assets in early development, than has been the case prior to the last decade.

Item Type:	Article
Date Deposited:	13 Dec 2023 00:45
Last Modified:	13 Dec 2023 00:45
URI:	https://oak.novartis.com/id/eprint/51033