ABSTRACT

This chapter provides short-term tests of acute biological action and safety in adult volunteers. Human growth hormone (hGH) is a 191 amino acid polypeptide hormone which is secreted by the pituitary gland and has profound effects on skeletal growth in the immature human. It is clear that hGH also plays a role in the modulation of carbohydrate metabolism. Adequate amounts of the recombinant DNA synthesized hGH has been produced so that extensive biological testing has been carried out in both animal models and in humans. Adequate amounts of the recombinant DNA synthesized hGH has been produced so that extensive biological testing has been carried out in both animal models and in humans. Animal testing in rats and rabbits showed that the synthetic hGH was biologically active in animals, and equipotent to pituitary hGH. Furthermore, the recombinant DNA synthetic hGH was remarkably free of side effect in the acute animal studies.