How safe are bioequivalence studies in healthy volunteers?

Therapie

Volumn 51, Issue 4, 1996, Pages 410-413

  Huic, M ^a   Vrhovac, B ^a   Macolic Sarinic, V ^a   Francetic, I ^a   Bakran, I ^a   Giljanovic, S ^a  

^a KBC Zagreb   (Croatia)

Author keywords

Bioequivalence studies; Healthy volunteers; XDRs

Indexed keywords

BROMOCRIPTINE; FUROSEMIDE; GENERIC DRUG; GLIPIZIDE; TICLOPIDINE;

ADVERSE DRUG REACTION; BIOEQUIVALENCE; CLINICAL TRIAL; CONFERENCE PAPER; DATA ANALYSIS; DISEASE SEVERITY; EDEMA; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMPOTENCE; META ANALYSIS; NAUSEA; NORMAL HUMAN; NOSE CONGESTION; PRIORITY JOURNAL; SWEATING; TINNITUS; VOLUNTEER;

ADOLESCENT; ADULT; CROATIA; FEMALE; HEALTHY WORKER EFFECT; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; RETROSPECTIVE STUDIES; RISK; THERAPEUTIC EQUIVALENCY; VOLUNTARY WORKERS;

EID: 0029782474     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (8)

1. Orme M, Harry J, Routledge P, Hobson S. Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Br J Clin Pharmacol 1989; 27: 125.
2. Royle JM, Snell ES. Medical research on normal volunteers. Br J Clin Pharmacol 1986; 21: 548.
3. Cardon PV, Dommel FW, Trumble RR. Injuries to research subject. N Engl J Med 1976; 295: 650.
4. Karch FE, Lasagna L. Adverse drug reactions. A critical review. JAMA 1975; 234: 1236.
5. Document of the Collaboratory ADR monitoring centre, Geneva: WHO 1994.
6. Harry JD. Research on healthy volunteers - a report of the Royal College of Physicians. Br J Clin Pharmacol 1987; 23: 379-381.
7. Inter-changeable multi-source pharmaceutical products. WHO Draft guideline on marketing requirements 1994; 4.
8. Vrhovac R, Francetic I, Rotim K. Drug trials on healthy volunteers in Yugoslavia. Clin Pharmacol Toxicol 1990; 28: 375-379.