Utility of Exposure-Response Analysis in Regulatory Decision on the Selection of Starting Dose of Pasireotide for Cushing Disease

J Clin Pharmacol. 2016 Aug;56(8):1035-8. doi: 10.1002/jcph.694. Epub 2016 Feb 10.

Authors

Jingyu Yu¹, Sang Chung², Immo Zadezensky², Ke Hu³, Christelle Darstein⁴, Jerry Nedelman³, Nitin Mehrotra¹

Affiliations

¹ Division of Pharmacometrics, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
² Division of Clinical Pharmacology 2, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
³ Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
⁴ Novartis Pharma AG, Basel, Switzerland.

PMID: 26686944
DOI: 10.1002/jcph.694

No abstract available

Keywords: Clinical Pharmacology (CPH); Clinical Trials (CTR); Endocrinology (END); Pharmacometrics; Regulatory/Scientific Affairs (REG).

MeSH terms

Hormones / therapeutic use*
Humans
Pituitary ACTH Hypersecretion / drug therapy*
Somatostatin / analogs & derivatives*
Somatostatin / therapeutic use

Substances

Hormones
Somatostatin
pasireotide