Comparative bioavailability and safety of a single dose and a multiple dose formulation of recombinant human follicle stimulating hormone (Gonal-F®)

Journal of Clinical Research

Volumn 4, Issue 19-26, 2001, Pages 89-96

  Munafo, A ^a   Bilham, W ^a   Trinchard Lugan, I ^a   Buraglio, M ^a  

^a Serono International SA   (Switzerland)

Author keywords

Bioequivalence; Formulations; r hFSH; Tolerability

Indexed keywords

ETHINYLESTRADIOL PLUS LEVONORGESTREL; FOLLITROPIN; RECOMBINANT FOLLITROPIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERANCE; FEMALE; HEADACHE; HUMAN; MASTALGIA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REPRODUCTION;

EID: 0034870464     PISSN: 13695207     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. Genetic engineering of human FSH (Gonal-F)
2. Sample size determination for bioequivalence assessment by means of confidence intervals
3. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH). I. Comparative pharmacokinetics with urinary human FSH
4. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH). II. Single doses and steady state pharmacokinetics
5. A comparison of the efficacy and tolerability of two recombinant human follicle-stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer