A framework to guide dose & regimen strategy for clinical drug development.


Journal

CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011

Informations de publication

Date de publication:
11 2021
Historique:
revised: 15 06 2021
received: 15 06 2021
accepted: 19 07 2021
pubmed: 26 9 2021
medline: 5 4 2022
entrez: 25 9 2021
Statut: ppublish

Résumé

Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, the idea of finding the right treatment at the right dose for the right patient to ensure an appropriate balance of risks and benefits is challenging and requires a multidisciplinary approach. In this paper, we present a framework developed as a tool for organizing knowledge and facilitating collaboration in development teams.

Identifiants

pubmed: 34562310
doi: 10.1002/psp4.12701
pmc: PMC8592517
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1276-1280

Informations de copyright

© 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

Références

CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429
pubmed: 28722322
Drug Discov Today. 2018 Apr;23(4):776-787
pubmed: 29406264
J Pharmacokinet Pharmacodyn. 2005 Apr;32(2):199-211
pubmed: 16283539
Biometrics. 2005 Sep;61(3):738-48
pubmed: 16135025
Clin Pharmacol Ther. 1997 Mar;61(3):275-91
pubmed: 9084453
Pharmacoepidemiol Drug Saf. 2002 Sep;11(6):439-46
pubmed: 12426927
JAMA. 2014 Jan 22-29;311(4):378-84
pubmed: 24449316
CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1276-1280
pubmed: 34562310

Auteurs

Oliver Sander (O)

Novartis Pharma AG, Basel, Switzerland.

Baldur Magnusson (B)

Novartis Pharma AG, Basel, Switzerland.

Inga Ludwig (I)

Novartis Pharma AG, Basel, Switzerland.

Astrid Jullion (A)

Novartis Pharma AG, Basel, Switzerland.

Christophe Meille (C)

Novartis Pharma AG, Basel, Switzerland.

Daniel Lorand (D)

Novartis Pharma AG, Basel, Switzerland.

Björn Bornkamp (B)

Novartis Pharma AG, Basel, Switzerland.

Markus Hinder (M)

Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.

Steven J Kovacs (SJ)

Translational Medicine, Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.

Michael Looby (M)

Novartis Pharma AG, Basel, Switzerland.

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Classifications MeSH