title: Clinical pharmacology and regulatory consequences of GnRH analogues in prostate cancer.
abstract: BACKGROUND
  GnRH (gonadotropin-releasing hormone) analogues are long-term known to be safe and effective in the clinical management of hormone-dependent advanced prostate cancer. However, their unusual mechanism of action of de-sensitizing pituitary receptors makes generic market entry challenging. In addition, safety aspects like initial flare-up, breakthrough escape, and miniflares render planning and organization of clinical registration trials a complex project.
  Regulatory requirements are high as these medicines are compared to bilateral surgical castration with a 100% success rate. GnRH analogues will be used probably even wider in the near future due to demographic development and extension of indications. However, they are challenged by their antagonistic counterparts, which are avoiding flare-up phenomena. The following article deals with regulatory requirements of GnRH analogues in regard to their clinical characteristics.
authors.affiliation: Federal Institute of Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany, niels.eckstein@bfarm.de.
authors.forename: Niels
authors.initials: N
authors.lastname: Eckstein
authors.forename: Bodo
authors.initials: B
authors.lastname: Haas
mesh_terms: D000818:Animals; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007987:Gonadotropin-Releasing Hormone / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D016568:Drugs, Generic; D007987:Gonadotropin-Releasing Hormone
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