Model-Based Assessments of CYP-Mediated Drug-Drug Interaction Risk of Alectinib: Physiologically Based Pharmacokinetic Modeling Supported Clinical Development

Author:

Cleary Yumi1,Gertz Michael1,Morcos Peter N.2,Yu Li2,Youdim Kuresh1,Phipps Alex3,Fowler Stephen1,Parrott Neil1

Affiliation:

1. Roche Innovation Center; Basel Switzerland

2. Roche Innovation Center; New York New York USA

3. Roche Innovation Center; Welwyn UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference43 articles.

1. PMDA Report on the Deliberation Results (Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (Japan) http://www.pmda.go.jp/files/000208811.pdf 2014

2. FDA Approval Letter: Application Number 208434Orig1s000 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000Approv.pdf 2015

3. EMA Summary of Opinion (initial authorisation) - Alecensa (alectinib) http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004164/WC500218188.pdf 2016

4. Metabolites of alectinib in human: their identification and pharmacological activity;Sato-Nakai;Heliyon,2017

5. Preclinical evaluation of the potential for cytochrome P450 inhibition and induction of the selective ALK inhibitor, alectinib;Sekiguchi;Xenobiotica,2017

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