When opportunity met aspirational goals: accelerator MS, microdosing and absolute bioavailability studies-Reference-Cited by-同舟云学术

When opportunity met aspirational goals: accelerator MS, microdosing and absolute bioavailability studies

Published:2012-08 Issue:15 Volume:4 Page:1831-1834
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Arnold Mark E¹,LaCreta Frank²

Affiliation:

1. Bioanalytical Sciences, Analytical & Bioanalytical Sciences, Bristol-Myers Squibb, PO Box 4000, Princeton, NJ 08543, USA.

2. Clinical Pharmacology & Pharmacometrics, Cardiovascular & Metabolic Diseases, Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb, NJ, USA

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.12.147

Reference4 articles.

1. Simultaneous oral therapeutic and intravenous14C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin.Br. J. Clin. Pharmacol.doi:10.1111/j.1365-2125.2012.04391.x. (Epub ahead of print) (2012).

2. ADEC PSC 109th meeting recommendations: Ratified recommendations of the 109th (2006/4) meeting of the Pharmaceutical Subcommittee (PSC) of the Australian Drug Evaluation Committee (ADEC) held 24 July 2006. Recommendation 1866.www.tga.gov.au/docs/html/adec/psc0109.htm

3. US FDA Center for Drug Evaluation and Research. Guidance for Industry, Investigators and Reviewers – Exploratory IND Studies (2006).www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf

4. Committee for Medicinal Products for Human Use. Position paper on the non-clinical safety studies to support clinical trials with a single micro dose. EMEA CPMP/SWP/2599/02/Rev. 1 (2004).www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002720.pdf

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