Non‐Labeled, Stable Labeled, or Radiolabelled Approaches for Provision of Intravenous Pharmacokinetics in Humans: A Discussion Piece-Reference-Cited by-同舟云学术

Non‐Labeled, Stable Labeled, or Radiolabelled Approaches for Provision of Intravenous Pharmacokinetics in Humans: A Discussion Piece

Published:2023-12-22 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Young Graeme C.¹^ORCID,Spracklin Douglas K.²^ORCID,James Alexander D.³^ORCID,Hvenegaard Mette G.⁴^ORCID,Pedersen Mette L.⁵,Wagner David S.⁶^ORCID,Georgi Katrin⁷,Schieferstein Hanno⁷,Bjornsdottir Inga⁸,Romeo Andrea A.⁹^ORCID,Cassidy Kenneth C.¹⁰,Da‐violante Georges¹¹,Blech Stefan¹²^ORCID,Schulz Simone I.¹³,Cuyckens Filip¹⁴^ORCID,Nguyen Mai Anh¹⁵^ORCID,Scarfe Graeme¹⁶^ORCID

Affiliation:

1. GSK Research &Development Ltd. Stevenage UK

2. Pfizer Inc. Groton Connecticut USA

3. Novartis Basel Switzerland

4. H. Lundbeck A/S Copenhagen Denmark

5. Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D AstraZeneca Gothenburg Sweden

6. AbbVie North Chicago Illinois USA

7. The Healthcare Business of Merck KGaA Darmstadt Germany

8. Novo Nordisk Maaloev Denmark

9. Roche Pharma Research and Early Development Basel Switzerland

10. Eli Lilly and Company Indianapolis Indiana USA

11. Technologie Servier Orleans France

12. Boehringer‐Ingelheim Pharma GmbH & Co. KG Biberach Germany

13. Bayer AG Wuppertal Germany

14. Janssen R&D Beerse Belgium

15. Sanofi, R&D Frankfurt Germany

16. Sosei Heptares Great Abington, Cambridge UK

Abstract

A review of the use of microdoses and isotopic microtracers for clinical intravenous pharmacokinetic (i.v. 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 i.v. PK data in humans becomes more routinely available for suitable assets in early development, than has been the case prior to the last decade.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3121

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