clinical trials; good manufacturing practice; investigational medical product; investigational medical product dossier; Medicines and Healthcare products Regulatory Agency; positron emission tomography; radiotracers; regulations
Indexed keywords
INVESTIGATIONAL MEDICAL PRODUCT;
PLACEBO;
TRACER;
UNCLASSIFIED DRUG;
ALGORITHM;
DRUG COST;
DRUG LEGISLATION;
DRUG MANUFACTURE;
DRUG MARKETING;
FOLLOW UP;
HEALTH SERVICE;
HUMAN;
IN VIVO STUDY;
LICENSING;
MEDICAL RESEARCH;
PATIENT SAFETY;
PHYSICIAN;
POSITRON EMISSION TOMOGRAPHY;
RADIATION PROTECTION;
REVIEW;
RISK ASSESSMENT;
TOTAL QUALITY MANAGEMENT;
UNITED KINGDOM;
ANIMALS;
CLINICAL TRIALS AS TOPIC;
HUMANS;
POSITRON-EMISSION TOMOGRAPHY;
RADIOPHARMACEUTICALS;
RESEARCH PERSONNEL;
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
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. Official J Eur Communities 2001; L121:34-44.
Good manufacturing practices for manufacture of investigational medicinal products. February 2010. Available at: http://ec.europa.eu/health/documents/ eudralex/vol-10/index-en.htm. Accessed 1 April 2011.
Guidance on investigational medicinal products (IMPs) and 'non investigational medicinal products' (NIMPs). 1 March 2011. Available at: http://ec.europa.eu/health/documents/eudralex/vol-10/index-en.htm. Accessed 1 April 2011.
Review of new regulations for the conduct of clinical trials of investigational medicinal products
DOI 10.1111/j.1471-0528.2007.01415.x
Bollapragada SS, Norrie JD, Norman JE. Review of new regulations for the conduct of clinical trials of investigational medicinal products. BJOG 2007; 114:917-921. (Pubitemid 47053874)
Is it a clinical trial of a medicinal product? Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/ Multidisciplinary/M3-R2/Step4/M3-R2-Guideline.pdf. Accessed 13 September 2011.
Clinical trials for medicines: Is a clinical trial authorisation (CTA) required? 11 March 2011. Available at: http://www.mhra.gov.uk/Howweregulate/ Medicines/Licensingofmedicines/Clinicaltrials/Isaclinicaltrialauthorisation CTArequired/index.htm. Accessed 1 April 2011.
New notification scheme for clinical trials. 1 April 2011. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/ CON114358. Accessed 22 December 2011.
Economic evaluation of PET and pet/ct in oncology: Evidence and methodologic approaches
Buck AK, Herrmann K, Stargardt T, Dechow T, Krause BJ, Schreyögg J. Economic evaluation of PET and PET/CT in oncology: evidence and methodologic approaches. J Nucl Med 2010; 51:401-412.
PET trials: additional information. 23 May 2011. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/ Clinicaltrials/SpecialInterestGroups/PET/PETAdditionalinformation/index.htm. Accessed 13 September 2011.
A list of investigational medicinal product dossiers (IMPDs) available through the Radiopharmacy Committee and Drug Development Committee sites. Available at: http://www.eanm.org/committees/radiopharmacy/rapha-impds.php? navId=672. Accessed 13 September 2011.
PET trials: general information. 11 February 2011. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/ Clinicaltrials/SpecialInterestGroups/PET/PETGeneralinformation/index.htm. Accessed 13 September 2011.
Quality risk management (Q9). November 2005. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Quality/Q9/ Step4/Q9-Guideline.pdf. Accessed 13 September 2011.
Guidance PET drugs-current good manufacturing practice (CGMP). December 2009. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070306.pdf. Accessed 13 September 2011.
Guidance PET drugs-current good manufacturing practice (CGMP) (small entity compliance guide). August 2011. Available at: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM266640.pdf. Accessed 13 September 2011.
Manufacturing and importation: good manufacturing practise (GMP). Available at: http://ec.europa.eu/health/human-use/quality/manufacturing- practices/index-en.htm. Accessed 14 September 2011.
EU guidelines to good manufacturing practice. Medicinal products for human and veterinary use. Annex 13: investigational medicinal products. 3 February 2010. Available at: http://ec.europa.eu/health/files/eudralex/vol-4/ 2009-06-annex13.pdf. Accessed 13 September 2011.
The rules governing medicinal products in the European Union-EU guidelines to good manufacturing practice medicinal products for human and veterinary use. Part I, Chapter 6: quality control. October 2005. Available at: http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/2005-10-chapter-6-en. pdf. Accessed 13 September 2011.
Strategies for clinical implementation and quality management of PET tracers, 2009. Available at: http://www-pub.iaea.org/books/IAEABooks/7983/ Strategies-for-Clinical-Implementation-and-Quality-Management-of-PET-Tracers. Accessed 8 November 2011.
Impurities: guideline for residual solvents Q3C (R5). 4 February 2011. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Quality/Q3C/Step4/Q3C-R5-Step4.pdf. Accessed 13 September 2011.
Guidance for industry CGMP for phase 1 investigational drugs. July 2008. Available at: http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm070273.pdf. Accessed 13 September 2011.
Annex 1: manufacture of sterile medicinal products. 14 February 2008 Accessed 13 September 2011
The rules governing medicinal products in the European Union-EU guidelines to good manufacturing practice medicinal products for human and veterinary use. Annex 1: manufacture of sterile medicinal products. 14 February 2008. Available at: http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/ 2008-02-12-gmp-annex1-en.pdf. Accessed 13 September 2011.
Quality risk management (ICH Q9). January 2011. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500002873.pdf. Accessed 14 September 2011.
Annex 3: manufacture of radiopharmaceuticals. 1 September 2008 Accessed 14 September 2011
EU guidelines to good manufacturing practice medicinal products for human and veterinary use, Vol. 4. Annex 3: manufacture of radiopharmaceuticals. 1 September 2008. Available at: http://ec.europa.eu/health/files/eudralex/vol-4/ 2008-09-annex3-en.pdf. Accessed 14 September 2011.
Directive 2001/83/Ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. Official J Eur Communities 2001; L 311:67-121.
Notes for applicants and holders of a manufacturer's license. August 2006. Available at: http://www.mhra.gov.uk/Publications/Regulatoryguidance/ Medicines/Guidancenotes/index.htm. Accessed 14 September 2011.
How to register your product under the traditional herbal medicines registration scheme: qualified and responsible persons. 9 May 2011. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/ RegisteredTraditionalHerbalMedicines/ HowtoregisteryourproductundertheTraditionalHerbalMedicinesRegistration Scheme/QualifiedandResponsiblePersons/index.htm. Accessed 14 September 2011.
