Comparison of the bioequivalence of generic versus branded clozapine

Journal of Clinical Psychiatry

Volumn 62, Issue SUPPL. 5, 2001, Pages 25-27

  Ereshefsky, L ^a   Glazer, W M ^a  

^a Mays Cancer Center at UT Health San Antonio   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLOZAPINE; GENERIC DRUG; NEUROLEPTIC AGENT;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG MARKETING; DRUG MONITORING; HUMAN; MANIC DEPRESSIVE PSYCHOSIS; NOTE; PRIORITY JOURNAL; PSYCHOSIS; SCHIZOPHRENIA;

ANTIPSYCHOTIC AGENTS; CLOZAPINE; DRUG APPROVAL; DRUG MONITORING; DRUGS, GENERIC; HUMANS; PRACTICE GUIDELINES; SCHIZOPHRENIA; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035075197     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (13)

1. Texas Medication Algorithm Project (TMAP) schizophrenia algorithms
2. United States Food and Drug Administration requirements for approval of generic drug products
3. Normal volunteers should not be used for bioavailability or bioequivalence studies of clozapine
4. Branded versus generic clozapine: Bioavailability comparison and interchangeability issues
5. Pharmacokinetic studies of antipsychotics in healthy volunteers versus patients
6. Clinical effects of a randomized switch of patients from Clozaril to generic clozapine
7. 2 receptor occupancy
8. Clozapine bioequivalence in patients
9. Pharmaceutical giants embroiled in generic-drug controversy