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Reportlinker Adds Advances in Drug-Diagnostic Co-Development

Thu, 05/26/2011 - 4:34am
Bio-Medicine.Org

NEW YORK, May 26, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Advances in Drug-Diagnostic Co-Development

http://www.reportlinker.com/p0511990/Advances-in-Drug-Diagnostic-Co-Development.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

Introduction

This report provides in depth analysis of the current and evolving regulatory framework for drugs and diagnostics in the US and EU and specific guidance for their co-development. Advances in biomarker development and validation are assessed and case studies given of regulatory approvals of drugs and companion tests. Strategies for drug-diagnostic co-development are evaluated.

Features and benefits

* Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development.

* Understand the biomarker discovery and validation process.

* Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU.

* Discover the various types of collaborations used by pharma and diagnostic companies.

* Assess the impact of drug-diagnostic co-development on key stakeholders including the industry, regulators, physicians, and pharmacy benefit managers.

Highlights

The regulatory landscape for drug-diagnostic co-development projects is evolving. The FDA and EMA both have similar biomarker qualification processes in place that enable companies to obtain advice or qual

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