Statistical approaches to indirectly compare bioequivalence between generics: A comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO

European Journal of Clinical Pharmacology

Volumn 68, Issue 12, 2012, Pages 1611-1618

  Gwaza, Luther ^a,b   Gordon, John ^c   Welink, Jan ^d   Potthast, Henrike ^e   Hansson, Henrik ^f   Stahl, Matthias ^g   García Arieta, Alfredo ^h  

^a Medicines Control Authority of Zimbabwe   (Zimbabwe)

^b UNIVERSITY OF ZIMBABWE   (Zimbabwe)

^c HEALTH CANADA   (Canada)

^d MEDICINES EVALUATION BOARD   (Netherlands)

^e Federal Institute for Drugs and Medical Devices   (Germany)

^f MEDICAL PRODUCTS AGENCY   (Sweden)

^g WORLD HEALTH ORGANIZATION   (Switzerland)

^h Division de Farmacologia y Evaluacion Clinica   (Spain)

Author keywords

Bioequivalence; Drug switching; Generic drug; Indirect treatmentcomparison; Malaria; Prequalification; Prequalification of Medicines Programme; Therapeutic equivalency; World Health Organization

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; GENERIC DRUG;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; HUMAN; INTERMETHOD COMPARISON; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REFERENCE VALUE; SAMPLE SIZE; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; STUDENT T TEST; TABLET FORMULATION; WORLD HEALTH ORGANIZATION;

ADULT; ANTIMALARIALS; AREA UNDER CURVE; ARTEMISININS; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; DRUGS, GENERIC; ETHANOLAMINES; FLUORENES; HUMANS; MALE; THERAPEUTIC EQUIVALENCY;

EID: 84871342607     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1396-1     Document Type: Article

References (18)

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2003) Guidance for Industry. Bioavailability and bioequivalence. Studies for orally adminsitered drug products - general considerations. CDER, Washington D.C.
2. Committee for Medicinal Products for Human Use (CHMP) (2010) Guideline on the investigation of bioequivalence. European Medicines Agency (EMA), London
3. WHO Expert Committee on Specifications for Pharmaceutical Preparations, World Health Organization (2006) Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series 937. . WHO Press, Geneva, pp 347-390
4. Chow SC, Liu J (1997) Meta-analysis for bioequivalence review. J Biopharm Stat 7(1):97-111
5. Chow SC, Shao J (1999) Bioequivalence review for drug interchangeability. J Biopharm Stat 9(3):485-497
6. Bucher HC, Guyatt GH, Griffith LE, Walter SD (1997) The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 50(6):683-691
7. Glenny AM, Altman DG, Song F, Sakarovitch C, Deeks JJ, D'Amico R, Bradburn M, Eastwood AJ (2005) Indirect comparisons of competing interventions. Health Technol Assess 9(26):1- 148
8. Maliepaard M, Banishki N, Gispen-de Wied CC, Teerenstra S, Elferink AJ (2011) Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin. Eur J Clin Pharmacol 67:1007-1016
9. Krauss GL, Caffo B, Chang YT, Hendrix CW, Chuang K (2011) Assessing bioequivalence of generic antiepilepsy drugs. Ann Neurol 70(2):221-228
10. Welch BL (1947) The generalisation of student's problems when several different population variances are involved. Biometrika 34(1-2):28-35
11. Schottker B, Luhmann D, Boulkhemair D, Raspe H (2009) Indirect comparisons of therapeutic interventions. GMS Health Technol Assess 5:Doc09
12. Johnston A, He X, Holt DW (2006) Bioequivalence of entericcoated mycophenolate sodium and mycophenolate mofetil: a metaanalysis of three studies in stable renal transplant recipients. Transplantation 82(11):1413-1418
13. Song F, Altman DG, Glenny AM, Deeks JJ (2003) Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. Br Med J 326(7387):472
14. Privitera M (2011) Is antiepileptic drug generic substitution always safe? Slow progress toward definitive answers. Ann Neurol 70(2):192-193
15. Edwards SJ, Clarke MJ, Wordsworth S, Borrill J (2009) Indirect comparisons of treatments based on systematic reviews of randomised controlled trials. Int J Clin Pract 63(6):841-854
16. Song F, Harvey I, Lilford R (2008) Adjusted indirect comparison may be less biased than direct comparison for evaluating new pharmaceutical interventions. J Clin Epidemiol 61(5):455-463
17. García Arieta A, Blázquez Pérez A, Rodriguez Mendizabal M (2006) Interchangeability between the different generic products in Spain: Gabapentin. In: 20th Congreso Nacional de la Sociedad Española de Farmacología Clínica, Puerto de la Cruz
18. Almeida Lopes R, Rocha Neves FA (2010) Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not for those with Enalapril Maleate. J Bras Nefrol 32(2):173-181