title: Discussion on early clinical drug development in the target population with respect to the field of reproductive endocrinology.
abstract: The study populations taking part in early clinical drug development of reproductive endocrine treatments are discussed. After having compared subjects in phase I studies with subsequent target populations, the question was posed as to whether the inclusion of the later target population could accelerate the developmental process. This applies only to certain specific clinical questions that are posed in phase I studies. From the authors' perspective, the key goal of rapid and well-structured early drug development is to be attained by using reliable surrogate markers that are able to reflect the clinical effects.
authors.affiliation: DINOX BV med investigations, Nijmegen, The Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Klipping
authors.forename: D
authors.initials: D
authors.lastname: Heger-Mahn
mesh_terms: D000328:Adult; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D003276:Contraceptives, Oral / Q000627:therapeutic use*; D004341:Drug Evaluation / Q000379:methods*; D004704:Endocrinology; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D018579:Patient Selection
chemical_list: D003276:Contraceptives, Oral