Bonnes pratiques d'achat pour les antipaludéens à ... - libdoc.who.int
Bonnes pratiques d'achat pour les antipaludéens à ... - libdoc.who.int
Bonnes pratiques d'achat pour les antipaludéens à ... - libdoc.who.int
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43. International programs. President’s Emergency Plan for AIDS Relief. Approved and tentatively approvedantiretrovirals in association with the President’s Emergency Plan. Silver Spring, Maryland, UnitedStates Food and Drug Administration.http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119232.htm44. McIntosh HM, Olliaro P. Artemisinin derivatives for treating uncomplicated malaria. Cochrane Databaseof Systematic Reviews, 2000, 2:CD000256.http://www.cochrane.org/reviews/en/ab000256.html45. Artemisinin derivatives: summary of non-clinical safety data. (Prepared for use in the assessment ofthe safety of active ingredients and drug products submitted by manufacturers of artemisinin-derivedantimalarial products for approval in the WHO Prequalification Scheme.) Available on the WHOPQP web site,http://www.<strong>who</strong>.<strong>int</strong>/prequal (under ‘Documents’).46. Ogbonna A, Uneke CJ. Artemisinin-based combination therapy for uncomplicated malaria in sub-Saharan Africa: the efficacy, safety, resistance and policy implementation since Abuja 2000. Trans RSoc Trop Med Hyg, 2008, 102: 621–627.47. Lignes directrices relatives aux <strong>Bonnes</strong> Pratiques Cliniques (BPC) <strong>pour</strong> l’essai des médicaments. Genève,Organisation mondiale de la Santé. Série de Rapports techniques, N° 850 ; annexe 3, 1995.http://apps.<strong>who</strong>.<strong>int</strong>/medicinedocs/fr/d/Jh2957f/48. Handbook. Good laboratory practice (GLP). Quality practices for regulated non-clinical research anddevelopment. Genève, Programme spécial de recherche et de développement concernant <strong>les</strong> maladiestropica<strong>les</strong> (TDR) coparrainé par l’UNICEF/le PNUD/la Banque mondiale/l’OMS, 2001.http://www.<strong>who</strong>.<strong>int</strong>/tdr/svc/publications/training-guideline-publications/good-laboratory-practice-handbook49. Guidelines for organizations performing in vivo bioequivalence studies. Genève, Organisation mondialede la Santé. Série de Rapports techniques, N° 937 ; annexe 9, 2006.http://whq<strong>libdoc</strong>.<strong>who</strong>.<strong>int</strong>/trs/WHO_TRS_937_eng.pdf50. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the start of shelf life ofthe finished dosage form. London, European Medicines Agency, 2001 (CPMP/QWP/072/96).http://www.emea.europa.eu/PDFs/human/qwp/007296en.pdf51. List of available <strong>int</strong>ernational chemical reference substances and <strong>int</strong>ernational infrared reference spectra.Genève, Organisation mondiale de la Santé. Série de Rapports techniques, N° 953 ; annexe 1, 2009.http://www.<strong>who</strong>.<strong>int</strong>/medicines/publications/pharmprep/pdf_trs953.pdf#page=8952. USP non-US standards: standards for artic<strong>les</strong> legally marketed outside the US. Rockville, Maryland,United States Pharmacopeial Convention, Inc., 2009.http://www.usp.org/standards/<strong>int</strong>ernational/53. Harmonised tripartite guideline Q2(R1). Validation of analytical procedures: text and methodology.Geneva, International Conference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use, 2009.http://www.ich.org/lob/media/media417.pdf54. Harmonised tripartite guideline Q6A. Specifications: test procedures and acceptance criteria for newdrug substances and new drug products: chemical substances. Geneva, International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2009.http://www.ich.org/LOB/media/MEDIA430.pdf55. Model certificate of analysis. Genève, Organisation mondiale de la Santé. Série de Rapports techniques,N° 902 ; annexe 10, 2002.http://whq<strong>libdoc</strong>.<strong>who</strong>.<strong>int</strong>/trs/WHO_TRS_902.pdf56. Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use inpharmaceutical products. Genève, Organisation mondiale de la Santé. Série de Rapports techniques,N° 953 ; annexe 4, 2009.http://www.<strong>who</strong>.<strong>int</strong>/medicines/publications/pharmprep/pdf_trs953.pdf#page=16488 <strong>Bonnes</strong> <strong>pratiques</strong> d’achat <strong>pour</strong> <strong>les</strong> antipaludéens à base d’artémisinine