Quality assurance of drugs used in clinical trials: proposal for adapting guidelines

Paul Newton and colleagues propose that clinical trial guidelines should include a requirement to assess and state the quality of the drugs and other medical products used

[1]  J. Wyatt,et al.  Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide , 2014, BMJ : British Medical Journal.

[2]  Isabelle Boutron,et al.  Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals , 2013, PLoS medicine.

[3]  David Moher,et al.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials , 2013, BMJ.

[4]  P. Newton,et al.  The Primacy of Public Health Considerations in Defining Poor Quality Medicines , 2011, PLoS Medicine.

[5]  Raffaella Ravinetto,et al.  Quality of medical devices and in vitro diagnostics in resource‐limited settings , 2011, Tropical medicine & international health : TM & IH.

[6]  Trudie Lang,et al.  Clinical research: time for sensible global guidelines , 2011, The Lancet.

[7]  Jeremy Howick,et al.  What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials , 2010, Annals of Internal Medicine.

[8]  L. Slutsker,et al.  Mefloquine pharmacokinetics and mefloquine-artesunate effectiveness in Peruvian patients with uncomplicated Plasmodium falciparum malaria , 2009, Malaria Journal.

[9]  P. Bossuyt,et al.  Standards for Reporting on Diagnostic Accuracy Studies , 2009 .

[10]  C. Mace,et al.  Substandard medicines in resource‐poor settings: a problem that can no longer be ignored , 2008, Tropical medicine & international health : TM & IH.

[11]  H. Mshinda,et al.  Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants. , 2007, The American journal of clinical nutrition.

[12]  Paul N Newton,et al.  Counterfeit anti-infective drugs. , 2006, The Lancet. Infectious diseases.

[13]  David Moher,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. , 2004, Family practice.

[14]  F. Sörgel,et al.  Lack of bioequivalence of a generic mefloquine tablet with the standard product , 1998, European Journal of Clinical Pharmacology.

[15]  C. Csillag.  Epidemic of counterfeit drugs causes concern in Brazil. , 1998, Lancet.

[16]  C. Csillag.  SÃO PAOLO Epidemic of counter feit drugs causes concern in Brazil , 1998, The Lancet.

[17]  L. Salako,et al.  Bioavailability of sulphate and dihydrochloride salts of quinine. , 1994, African journal of medicine and medical sciences.

[18]  D G Altman,et al.  The hidden effect of time. , 1988, Statistics in medicine.

[19]  T. R. Shaw.  The digoxin affair , 1974 .

[20]  黄亚明（整理）,et al.  Equator network , 2012 .

[21]  D. Barends,et al.  Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride. , 2011, Journal of pharmaceutical sciences.

[22]  J. Abraham.  The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[23]  I R König,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. , 2003, Clinical chemistry.

[24]  T. R. Shaw.  Trade names or approved names. Part III. Special cases. The digoxin affair. , 1974, Postgraduate medical journal.