Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets

International Journal of Clinical Pharmacology and Therapeutics

Volumn 45, Issue 5, 2007, Pages 293-299

  van Os, Sandra ^a   Relleke, M ^a   Piniella, P Muniz ^a  

^a SYNTHON BV   (Netherlands)

Author keywords

Bioequivalence; Pharmacokinetics; Risperidone; Solution; Tablet

Indexed keywords

PALIPERIDONE; RISPERIDONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMMON COLD; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; FEMALE; FLUSHING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHLEBITIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; VOLUNTEER;

EID: 34248382891     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/cpp45293     Document Type: Article

References (25)

1. 21 CRF 320.1. Code of federal regulation: bioavailability and bioequivalence requirements (1977). As amended in 2002.
2. Anderson S, Hauck WW. The transitivity of bioequivalence testing: potential for drift. Int J Clin Pharmacol Ther. 1996; 34: 369-374.
3. Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet. 1995; 346: 477-481.
4. Barone JA, Byerly WG. Determination of bioequivalence of psychotropic drugs and concerns involving product interchange. J Clin Psychiatry. 1986; 47 (Suppl): 28-32.
5. CPMP/EWP/QWP/1401/98. Note for Guidance on the Investigation of Bioavailability and Bioequivalence; 2001.
6. 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 provision 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 Journal of the European Communities, L 121/34-44; 2005.
7. Directive 2004/27/EC amending Directive 2001/83/EC on the community code relating to medicinal products for human use; 2004.
8. Ereshefsky L, Lacombe S. Pharmacological profile of risperidone. Can J Psychiatry. 1993; 38 (Suppl 3): S80-S88.
9. FDA Guidance for Industry. Waiver of in viva bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a Biopharmaceutics Classification System; 2000.
10. FDA Guidance for Industry. Bioanalytical method validation; 2001a.
11. FDA Guidance for Industry. Statistical approaches to establishing bioequivalence; 2001b.
12. FDA Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products - general considerations; 2003.
13. Green B. Focus on risperidone. Curr Med Res Opin. 2000; 16: 57-65.
14. Gutierrez R, Lee PI, Huang ML, Woestenborghs R. Risperidone: effects of formulations on oral bioavailability. Pharmacotherapy. 1997; 17: 599-605.
15. Hosalli P, Davis JM. Depot risperidone for schizophrenia. Cochrane Database Syst Rev. 2003; 4: 1-41.
16. ICH E6. Guideline for good clinical practice; 1996.
17. Jain NK, Patel VP, Pitchumoni CS. Sorbitol intolerance in adults. Prevalence and pathogenesis on two continents. J Clin Gastroenterol. 1987; 9: 317-319.
18. Livesey G. Tolerance of low-digestible carbohydrates: a general view. Br J Nutr. 2001; 85 (Suppl 1): 7-16.
19. Mannens G, Huang ML, Meuldermans W, Hendrickx J, Woestenborghs R, Heykants J. Absorption, metabolism, and excretion of risperidone in humans. Drug Metab Dispos. 1993; 21: 1134-1141.
20. Megens AAHP, Awouters FHL. In vivo pharmacological profile of 9-hydroxyrisperidone, the major metabolite of the novel antipsychotic risperidone. Drug Dev Res. 1994; 33: 399-412.
21. OECD. Principles of good laboratory practice (as revised in 1997). OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1, ENV/MC/ CHEM(98)17, Environment Directorate, Paris 1998.
22. Risperdal SmPC. Electronic Medicines Compendium. www.medicines.org.uk; 2004.
23. Sheitman BB, Lee H, Strauss R, Lieberman JA. The evaluation and treatment of first-episode psychosis. Schizophr Bull. 1997; 23: 653-661.
24. Wijnand HP. Updates of bioequivalence programs (including statistical power approximated by Student's t). Comput Methods Programs in Biomed. 1994; 42: 275-281.
25. Wyatt RJ. Neuroleptics and the natural course of schizophrenia. Schizophr Bull. 1991; 17: 325-351.