Development and delivery of clinical pharmacology in regulatory agencies

British Journal of Clinical Pharmacology

Volumn 73, Issue 6, 2012, Pages 866-869

  Breckenridge, Alasdair ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; CLINICAL PHARMACOLOGY; COST EFFECTIVENESS ANALYSIS; DRUG SAFETY; HEALTH SERVICE; HUMAN; MEDICOLEGAL ASPECT; NOTE; PRIORITY JOURNAL; PUBLIC HEALTH; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; VOLUNTARY REPORTING;

CLINICAL TRIALS AS TOPIC; COST-BENEFIT ANALYSIS; GOVERNMENT AGENCIES; GREAT BRITAIN; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOLOGY, CLINICAL; PHARMACOVIGILANCE; RISK MANAGEMENT;

EID: 84860677518     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04226.x     Document Type: Note

References (3)

1. Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov 2009; 8: 779-82.
2. Raine J, Wise L, Talbot J, Aronson JK. Proactive pharmacovigilance and risk management. In: Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, 6th edn, eds Talbot J, Aronson JK. Oxford: Wiley-Blackwell, 2012; 389-409.
3. The European Parliament and the Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Commun 2001; L121: 34-44.