Bioequivalence of liquid and freeze-dried recombinant human follicle-stimulating hormone

Current Medical Research and Opinion

Volumn 21, Issue 1, 2005, Pages 121-125

  Lugan, Isabelle ^a   Febbraro, S ^b   Lecuelle, H ^a   Papasouliotis, O ^a   Ho Nguyen, Q ^a   Buraglio, M ^a  

^a Serono International SA   (Switzerland)

^b SIMBEC RESEARCH LTD   (United Kingdom)

Author keywords

Filled by mass; Follicle stimulating hormone, recombinant human; Freeze dried; Liquid; Pharmacokinetics; Therapeutic equivalency

Indexed keywords

GOSERELIN; ORAL CONTRACEPTIVE AGENT; RECOMBINANT FOLLITROPIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE TIME EFFECT RELATION; DRUG BIOAVAILABILITY; DRUG FORMULATION; ERYTHEMA; FEMALE; FREEZE DRYING; HEADACHE; HUMAN; HUMAN EXPERIMENT; INJECTION SITE REACTION; LIQUID; MALE; NORMAL HUMAN; OPEN STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; UPPER RESPIRATORY TRACT INFECTION;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; CROSS-OVER STUDIES; FEMALE; FOLLICLE STIMULATING HORMONE; FREEZE DRYING; HUMANS; MALE; MIDDLE AGED; STATISTICS, NONPARAMETRIC; THERAPEUTIC EQUIVALENCY;

EID: 14744271371     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079904X18027     Document Type: Article

References (8)

1. Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem 1981;50:465-95
2. Follitropin. In: Dollery C, editor. Therapeutic drugs, 2nd ed. Edinburgh: Churchill Livingstone; 1999: F146-9
3. Lunenfeld B. Development of gonadotrophins for clinical use. Reprod Biomed Online 2002;4(Suppl 1):11-7
4. Marzo A, Balant LP. Bioequivalence. An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products. Arzneimittelforschung 1995;45:109-15
5. Pabst G, Jaeger H. Review of methods and criteria for the evaluation of bioequivalence studies. Eur J Clin Pharmacol 1990;38:5-10
6. Daya S. Updated meta-analysis of recombinant follicle-stimulating hormone (FSH) versus urinary FSH for ovarian stimulation in assisted reproduction. Fertil Steril 2002;77:711-4
7. Ravhon A, Lavery S, Aurell R, Trew G, Margara R, Winston R. Clinical experience with recombinant follicle-stimulating hormone (FSH) and urinary FSH: a retrospective case-controlled analysis. Fertil Steril 2001;75:920-5
8. Driebergen R, Baer G. Quantification of follicle stimulating hormone (follitropin alfa): is in vivo bioassay still relevant in the recombinant age? Curr Med Res Opin 2003;19:41-6