title: Utility of Exposure-Response Analysis in Regulatory Decision on the Selection of Starting Dose of Pasireotide for Cushing Disease.
authors.affiliation: Division of Pharmacometrics, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Jingyu
authors.initials: J
authors.lastname: Yu
authors.affiliation: Division of Clinical Pharmacology 2, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Sang
authors.initials: S
authors.lastname: Chung
authors.affiliation: Division of Clinical Pharmacology 2, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Immo
authors.initials: I
authors.lastname: Zadezensky
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Hu
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Christelle
authors.initials: C
authors.lastname: Darstein
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Jerry
authors.initials: J
authors.lastname: Nedelman
authors.affiliation: Division of Pharmacometrics, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Mehrotra
mesh_terms: D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D047748:Pituitary ACTH Hypersecretion / Q000188:drug therapy*; D013004:Somatostatin / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D006728:Hormones; D013004:Somatostatin; C517782:pasireotide
keywords: Clinical Pharmacology (CPH); Clinical Trials (CTR); Endocrinology (END); Pharmacometrics; Regulatory/Scientific Affairs (REG)