CLINICAL PHARMACOLOGY and BIOPHARMACEUTICS REVIEW

Center for Drug Evaluation and Research Application Number 20-972 Clinical Pharmacology and Biopharmaceutics Review

MEMORANDUM DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration

Please find here attached the draft Clinical Pharmacology/Biopharmaceutics Review of NDA 22,527.

Clinical Pharmacology and Biopharmaceutics Review

Tiotropium bromide monohydrate is an anticholinergic drug with specificity for muscarinic receptors, proposed to be used for the long-term, once-daily, maintenance treatment of bronchospasm and dyspnea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The proposed dosage of tiotropium is inhalation of the contents of one capsule (18 μg of ...

Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies.

Gualberto Ruaño1,2, Jerry M Collins3, Andrew J Dorner4, Sue-Jane Wang5, Roberto Guerciolini6 & Shiew-Mei Huang†7 †Author for correspondence 1President, Genomas LLC, New Haven, CT, USA 2Department of Biochemistry and Molecular Biology, George Washington University, Washington DC, USA 3Director, Laboratory of Clinical Pharmacology, CDER, FDA, USA 4Senior Director, Molecular Medicine, Wyeth Resear...

Population Pharmacokinetic Analysis of Therapeutic Drug Monitoring Data in Optimizing Pharmacotherapy of Antiepileptic Drugs

Katarina Vučićević1, Branislava Miljković1, Sandra Vezmar Kovačević1, Zoran Todorović2, Milica Prostran2 and Iztok Grabnar3 1Department of Pharmacokinetics and Clinical Pharmacy, Faculty of Pharmacy, University of Belgrade, 2Department of Pharmacology, Clinical Pharmacology and Toxicology, School of Medicine, University of Belgrade, 3Chair of Biopharmaceutics and Pharmacokinetics, Faculty of Ph...