FDA Finalizes Guidance on Osteoporosis Drug Development
The FDA issued final recommendations for designing nonclinical bone quality studies to support osteoporosis drug and biologic approvals.
The guidance includes general recommendations for study designs and evaluations. For example, the agency advises sponsors to conduct a study in rats and in a larger nonrodent species, such as nonhuman primates, sheep, pigs or dogs.
Sponsors should generally conduct nonclinical studies with a minimum of two doses, including a dose that has an optimal pharmacological effect on bone mass, in addition to a high dose that’s an “adequate multiple” of the optimally effective dose, the agency says.