Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism

Author:

Khurana Manoj1,Zadezensky Immo2,Lowy Naomi3,Roman Dragos3,Guettier Jean‐Marc4,Li Liang1,Florian Jeffry3,Sahajwalla Chandrahas G.1,Sinha Vikram5,Mehrotra Nitin5

Affiliation:

1. Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration (FDA) Silver Spring Maryland, USA

2. EMD Serono Washington DC USA

3. Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration (FDA) Silver Spring Maryland, USA

4. Sanofi‐Aventis Deutschland GmbH Industriepark Hoechst Frankfurt Germany

5. Merck & Co North Wales Pennsylvania, USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference23 articles.

1. Quantitative and systems pharmacology in the post‐genomic era: new approaches to discovering drugs and understanding therapeutic mechanisms. .

2. The Regulation of Renal Calcium Excretion: An Approach to Hypercalciuria

3. BLA125511 (Natpara®) FDA Label. .

4. BLA125511 FDA Medical Officer Review(page 48 of 169). .

5. PK in late phase trials: collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing;Wang Y.;Applied Clinical Trials,2012

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