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Literature DB >> 21193854

Evolution of regulatory frameworks.

Alasdair Breckenridge¹, Peter Feldschreiber, Simon Gregor, June Raine, Leigh-Ann Mulcahy.

Abstract

Mesh：

Substances：

Year: 2011 PMID： 21193854 DOI： 10.1038/nrd3348

Source DB: PubMed Journal: Nat Rev Drug Discov ISSN： 1474-1776 Impact factor: 84.694

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4 in total

Review 1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Authors: Hans-Georg Eichler; Francesco Pignatti; Bruno Flamion; Hubert Leufkens; Alasdair Breckenridge
Journal: Nat Rev Drug Discov Date: 2008-09-12 Impact factor: 84.694

Review 2. New approaches to drug safety: a pharmacovigilance tool kit.

Authors: Lesley Wise; John Parkinson; June Raine; Alasdair Breckenridge
Journal: Nat Rev Drug Discov Date: 2009-09-18 Impact factor: 84.694

3. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Authors: Jan Regnstrom; Franz Koenig; Bo Aronsson; Tatiana Reimer; Kristian Svendsen; Stelios Tsigkos; Bruno Flamion; Hans-Georg Eichler; Spiros Vamvakas
Journal: Eur J Clin Pharmacol Date: 2009-11-20 Impact factor: 2.953

Review 4. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

Authors: Hans-Georg Eichler; Brigitte Bloechl-Daum; Eric Abadie; David Barnett; Franz König; Steven Pearson
Journal: Nat Rev Drug Discov Date: 2010-02-26 Impact factor: 84.694

4 in total

3 in total

Evolution of regulatory frameworks.

Review 1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Review 2. New approaches to drug safety: a pharmacovigilance tool kit.

3. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Review 4. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

1. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

2. Timelines of translational science: From technology initiation to FDA approval.

3. The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.