48
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Generic Substitution and Bioequivalence of Sodium Valproate at Steady-State in Healthy Volunteers

, , , &
Pages 183-195 | Published online: 17 Nov 2008

REFERENCES

  • JF Marriott. BNF Recommendations on substitution: are they followed in practice?. Pharmaceutical Journal. 1999; 263 (7059):289–292.
  • Assessment: generic substitution for antiepileptic medication. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology1990; 40(11):1641–1643.
  • MR Nuwer, TR Browne, WE Dodson, and et al Generic substitutions for antiepileptic drugs. Neurology. 1990; 40 (11):1647–1651.
  • MS Duh, A Gosselin, and PE Paradis. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007; 48 (3):464–469.
  • G Koch, and JP Allen. Untoward effects of generic carbamazepine therapy. Arch Neurol. 1987; 44 (6):578–579.
  • JT MacDonald. Breakthrough seizure following substitution of Depakene capsules (Abbott) with a generic product. Neurology. 1987; 37 (12):1885.
  • SI Borst, and CH Lockwood. Plasma level studies on different brands of sodium diphenylhydantoin (DPH) and primidone. Int J Clin Pharmacol Biopharm. 1975; 12 (3):309–314.
  • S Pynnonen, R Mantyla, and E Iisalo. Bioavailability of four different pharmaceutical preparations of carbamazepine. Acta Pharmacol Toxicol (Copenh). 1978; 43 (4):306–310.
  • K Kauko, and P Tammisto. Comparison of two generically equivalent carbamazepine preparations. Ann Clin Res. 1974; 6 (Suppl 11):21–25.
  • SC Bhatia, AD Bhatt, RJ Bakshi, and et al Comparative bioavailability with two brands of carbamazepine-Tegretol and Mazetol in healthy volunteers. J Assoc Physicians India. 1988; 36 (10):611–612.
  • RA Shakir, RH Johnson, DG Lambie, and et al Comparison of sodium valproate and phenytoin as single drug treatment in epilepsy. Epilepsia. 1981; 22 (1):27–33.
  • N Callaghan, RA Kenny, B O'Neill, and et al A prospective study between carbamazepine, phenytoin and sodium valproate as monotherapy in previously untreated and recently diagnosed patients with epilepsy. J Neurol Neurosurg Psychiatry. 1985; 48 (7):639–644.
  • JS Barrett, V Batra, A Chow, and et al PhRMA perspective on population and individual bioequivalence. J Clin Pharmacol. 2000; 40 (6):561–570.
  • FM Besag. Is generic prescribing acceptable in epilepsy?. Drug Saf. 2000; 23 (3):173–182.
  • Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products—General considerations. US Food and Drug Administration, Centre for Drug Evaluation and Research; U.S. March 2003. Revision 1.
  • Guidance for industry: Bioequivalence requirements—Comparative bioavailability studies conducted in the Fed State. Published by Ministry of Health Canada. Effective 2005.
  • A Pidgen. Bioequivalence and generic prescribing: An industrial view. J Pharmacol. 1996; 48 (1):11–16.
  • BF Banahan, and EM Kolassa. A physician survey on generic drugs and substitution of critical dose medications. Arch Intern Med. 1997; 157 (18):2080–2088.
  • JD Henderson, and RH Esham. Generic substitution: Issues for problematic drugs. South Med J. 2001; 94 (1):16–21.
  • Featured Report: Generic drugs. Report, presented as Council on Scientific Affairs Report 6 at the 2002 AMA Annual Meeting, represents information and AMA policy on this subject as of June 2002. Available from URL: http://www.amaassn.org/ama/pub/category/15279.htmL [Accessed March 2, 2006].
  • PH Rheinstein. Therapeutic inequivalence. Drug Saf. 1990; 1 (5 Suppl):114–119.
  • G Borgheini. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther. 2003; 25 (6):1578–1592.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.