Studies on pharmacokinetics of recombinant human follicle stimulating hormone

Follicle stimulating hormone (FSH) is a heterodimeric glycoprotein hormones secreted by anterior pituitary gland and is composed of two non-covalently linked protein subunits, the α-subunit which is common to other glycoprotein hormones, and the a hormone-specific β-subunit. FSH preparation plays an essential role in the treatment of human infertility. Recombinant human follicle stimulating hormone (r-hFSH) is now produced by recombinant DNA technology and has been introduced to the market. Pharmacokinetics studies of single and repeated dose were conducted in rat and monkey. Since u-hFSH and r-hFSH have similar pharmacokinetic profiles in vivo in both animals and humans. Toxicokinetic and clinical studies however confirmed that animals had been exposed to high levels of r-hFSH despite antibody formation. In this reviews, all relevant pharmacokinetic and pharmacodynamic information of FSH and r-hFSH provides a scientific basis and is value for reasonable application of the product.