An integrated assessment of the ADME properties of the CDK4/6 Inhibitor ribociclib utilizing preclinical in vitro, in vivo, and human ADME data-Reference-Cited by-同舟云学术

An integrated assessment of the ADME properties of the CDK4/6 Inhibitor ribociclib utilizing preclinical in vitro, in vivo, and human ADME data

Published:2020-06 Issue:3 Volume:8 Page:
ISSN:2052-1707
Container-title:Pharmacology Research & Perspectives
language:en
Short-container-title:Pharmacol Res Perspect

Author:

James Alexander D.¹^ORCID,Schiller Hilmar¹,Marvalin Cyrille¹,Jin Yi¹,Borell Hubert¹,Roffel Ad F.²,Glaenzel Ulrike¹,Ji Yan³,Camenisch Gian¹

Affiliation:

1. PK Sciences (ADME) Novartis Institutes for Biomedical Research Basel Switzerland

2. PRA Health Sciences, Scientific and Medical Affairs Groningen the Netherlands

3. PK Sciences (Oncology TA) Novartis Institutes for Biomedical Research East Hanover USA

Funder

Novartis Pharma

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,Neurology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/prp2.599

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4. International conference onHarmonisation Guidance on non‐clinical safety studies for human clinical trials and marketing authorization for pharmaceuticalsM3(R2). EMA: London UK 2009; (https://www.ema.europa.eu/en/ich‐m3‐r2‐non‐clinical‐safety‐studies‐conduct‐human‐clinical‐trials‐pharmaceuticals) Accessed May 15 2019.

5. U.S. Food and Drug Administration Safety testing of drug metabolites: guidance for industry.FDA: Silver Spring 2016; (https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/safety‐testing‐drug‐metabolites). Accessed May 15 2019.

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