Biological potency is determined by measuring the increase in body weight induced in hypophysectomized rats. The reconstituted solution has a pH of 6.5 to 8.5. Saizen is available in vials. Clinical studies in normal adults also demonstrated equivalent pharmacokinetics. Saizen stimulates skeletal growth in prepubertal children with pituitary growth hormone deficiency.
Skeletal growth is accomplished at the epiphyseal plates at the ends of long bone.
Linear growth continues until the growth plates fuse at the end of puberty. Growth hormone of human pituitary origin influences the size and function of internal organs and increases red cell mass. Saizen has been shown to promote similar organ weight increase to pituitary human growth hormone in an adequate animal model. B. Protein Metabolism Linear growth is facilitated in part by growth hormone-stimulated protein synthesis. This is reflected by increased cellular uptake of amino acids and nitrogen retention as demonstrated by a decline in urinary nitrogen excretion and blood urea nitrogen during growth hormone therapy.