Epilepsy — Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets
Citation(s)
Bialer M Extended-release formulations for the treatment of epilepsy. CNS Drugs. 2007;21(9):765-74. doi: 10.2165/00023210-200721090-00005.
Dulac O, Alvarez JC Bioequivalence of a new sustained-release formulation of sodium valproate, valproate modified-release granules, compared with existing sustained-release formulations after once- or twice-daily administration. Pharmacotherapy. 2005 Jan
Dutta S, Reed RC, Cavanaugh JH Absolute bioavailability and absorption characteristics of divalproex sodium extended-release tablets in healthy volunteers. J Clin Pharmacol. 2004 Jul;44(7):737-42. doi: 10.1177/0091270004266782.
Perucca E Extended-release formulations of antiepileptic drugs: rationale and comparative value. Epilepsy Curr. 2009 Nov-Dec;9(6):153-7. doi: 10.1111/j.1535-7511.2009.01326.x.
Roberts D, Easter D, O'Bryan-Tear G Epilim chrono: a multidose, crossover comparison of two formulations of valproate in healthy volunteers. Biopharm Drug Dispos. 1996 Mar;17(2):175-82. doi: 10.1002/(SICI)1099-081X(199603)17:23.0.CO;2-J.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
