Equivalence of two generic brands of amlodipine besylate under biowaiver conditions

International Journal of Pharmacy and Pharmaceutical Sciences

Volumn 4, Issue 2, 2012, Pages 265-268

  Olusola, Akinleye M ^a   Olubukola, Oyetunde O ^a   Emeka, Okpara H ^a   Lilian, Ayerota E ^a  

^a UNIVERSITY OF LAGOS   (Nigeria)

Author keywords

BCS; Bioequivalence; Biowaiver; Generic medicines and amlodipine

Indexed keywords

AMLODIPINE BESYLATE; GENERIC DRUG;

ARTICLE; BIOEQUIVALENCE; DRUG QUALITY; DRUG SOLUBILITY; PH; PHYSICAL CHEMISTRY; TABLET DISINTEGRATION; TABLET FORMULATION; ULTRAVIOLET SPECTROPHOTOMETRY;

EID: 84859941862     PISSN: None     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. Health Action International Africa. 30 years of Essential drugs list: Celebrating the gains. Health Action International Africa Network Update 2007; 7: 1-2.
2. Garattini L, Tediosi F. A comparative analysis of generics markets in five European countries. Health policy 2000; 51: 149-162
3. Al-Gedadi N, Hassali M. 'Pharmacists' view on generic drugs: A review of literature', Journal of Generic Drugs 2000; 5(3): 209-218.
4. DeJoncheere K R, Rietveld HA, Huttin C. Experiences with generics. Int J Risk Saf Med 2002; 15: 101-109
5. Hassali M A, Kong D C, Stewart K. 'Generic drugs: perceptions of consumers in Melbourne, Australia' International Journal of Pharmacy Practice 2005; 13: 257-264.
6. Dighe SV. 'A review of the safety of generic drugs' Transplantation Proceedings 1991; 31: (suppl 3A), 23S-24S.
7. King DR, Kanavos P. Encouraging the use of generic medicines: Implications for transition economies. Croat. Med. J. 2002; 43 (4): 462-469.
8. Lindenberg M, Kopp S, Dressman J. 'Classification of orally administered drugs on the World Health Organization Model list of essential drugs according to the 4. Biopharmaceutics Classification System' Eur J Pharm Biopharm 2004; 58: 265-278.
9. FDA/CDER. Guidance for industry. Waiver of In vivo bioavailability and bioequivalence studies for immediate- release solid oral dosage forms based on a biopharmaceutics classification system,2000 Available at http://www.fda.gov/cder/guidance/index.htm (Accessed 19/05/2006).
10. WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, No. 937, Annex 8. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; World Health Organization: Geneva.
11. Blume H, Schug B. The Biopharmaceutics Classification System (BCS): class III drugs better candidates for BA/BE waiver? Eur J Pharm Sci. 1999; 9: 117-121.
12. Somnath S, Sunil C, Bhaswat C. Biowaver monograph for immediate release solid oral dosage forms:- Ofloxacin, Int J Pharm Pharm Sci, 2010; 2(4): 156-161.
13. Lokamatha KM, Bharathi A, Shnata Kumar SM, Rama Rao N. Effect of PVP-K30 on complexation and dissolution rate of Nevirapine-β-cyclodextrin complexes. Int J Pharm Pharm Sci, 2010; 2(4): 169-176.
14. Shohin IE, Ramenskaya GV, Vasilenko GF, Malashenko EA. Invitro dissolution kinetics of amlodipine tablets marketed in Russia under biowaivers conditions. Dissolution Techonlogies 2010
15. British Pharmacopoeia Volume I & II. British Pharmacopoeia commission. The stationery office limited, London; 2007. pp 249-267.
16. Food Drug and Administration (FDA). Guideline on the validation of analytical procedures: methodology (62 FR 27463). International conference on Harmonisation ICH Harmonised Tripartite Guidelines, Biotechnical services INC North Little Rock USA: FDA;1997
17. Kirking DM, Gaither CA, Ascione FJ, Welage LS. Physicians' Individual and Organizational Views on Generic Medications. J Am Pharm Assoc 2001; 41(5): 718-722.