Issues in Preclinical and Clinical Development for Drugs to Treat Osteoporosis

The clinical development of drugs for the treatment of osteoporosis is required to satisfy specific regulatory guidelines prior to approval for marketing. In 1994, the US FDA released draft guidelines covering preclinical and clinical development of osteoporosis drugs of postmenopausal osteoporosis.52 The World Health Organization has developed similar guidelines53 and these are available on its website. The FDA guidelines are under current review and variations may be expected. In addition, as these guidelines have continuing draft status, particular requirements could be open to negotiation, as shown by the recent approval of teriparatide (PTH 1-34), with phase III data of approximately 2 years' duration rather than the 3 years described in the guidelines.

Blood Pressure Health

Blood Pressure Health

Your heart pumps blood throughout your body using a network of tubing called arteries and capillaries which return the blood back to your heart via your veins. Blood pressure is the force of the blood pushing against the walls of your arteries as your heart beats.Learn more...

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