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AAPS J. 2013 Oct;15(4):933-40. doi: 10.1208/s12248-013-9495-1. Epub 2013 Jun 21.

Therapeutic protein drug-drug interactions: navigating the knowledge gaps-highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA workshop.

Author information

1
Department of Drug Metabolism & Pharmacokinetics, Genentech Inc., South San Francisco, California, USA, kenny.jane@gene.com.

Abstract

The investigation of therapeutic protein drug-drug interactions has proven to be challenging. In May 2012, a roundtable was held at the American Association of Pharmaceutical Scientists National Biotechnology Conference to discuss the challenges of preclinical assessment and in vitro to in vivo extrapolation of these interactions. Several weeks later, a 2-day workshop co-sponsored by the U.S. Food and Drug Administration and the International Consortium for Innovation and Quality in Pharmaceutical Development was held to facilitate better understanding of the current science, investigative approaches and knowledge gaps in this field. Both meetings focused primarily on drug interactions involving therapeutic proteins that are pro-inflammatory cytokines or cytokine modulators. In this meeting synopsis, we provide highlights from both meetings and summarize observations and recommendations that were developed to reflect the current state of the art thinking, including a four-step risk assessment that could be used to determine the need (or not) for a dedicated clinical pharmacokinetic interaction study.

PMID:
23794076
PMCID:
PMC3787234
DOI:
10.1208/s12248-013-9495-1
[Indexed for MEDLINE]
Free PMC Article
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