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| Microdosing - The Past 5 Years Date Published: 01 Nov 2008 Expert Opinion, Drug Metabolism and Toxicology: A review of current literature on microdosing and assess how well microdose data have predicted the pharmacokinetics obtained at a therapeutic dose. read more >> |
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| Recent applications of AMS in metabolism and PK Date Published: 01 Aug 2008 Expert Opinion, Drug Metabolism and Toxicology: This review addresses the metabolism and pharmacokinetics relevant to cases where therapeutic drug concentrations are achieved in humans. It focusses on two study designs: i) administration of tracer 14C-drug intravenously with a simultaneous non-labelled extravascular therapeutic dose; and ii) use of low levels of 14C-drug during Phase I studies to investigate the quantitative metabolism of the drug in humans early, as required by the FDA guidelines issued February 2008. read more >> |
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| FDA Guidance For Industry Date Published: 01 Feb 2008 US Food and Drug Administration, Guidance for Industry. Safety Testing of Drug Metabolites. read more >> |
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| PK Investigation of Imatinib in Chronic Myeloid Leukemia Patients Date Published: 01 Feb 2007 Clinical Cancer Research: Pharmacokinetic Investigation of Imatinib Using Accelerator Mass Spectrometry in Patients with Chronic Myeloid Leukemia. read more >> |
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| Regulatory Mass Balance Study for an autoradiolytic oncologic in patients Date Published: 01 Feb 2007 Investigational New Drugs : Mass Balance study on a microtubule stabilizing epothilone B analogue. read more >> |
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| Review of Human Phase 0 Clinical Trials Date Published: 22 Jun 2006 A review of Human Phase 0 (Microdosing) Clinical Trials Following the US FDA Exploratory New Drug Studies Guidance. read more >> |
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| 'CREAM' - 5 compound Microdosing Trial Date Published: 01 May 2006 Clinical Pharmacology and Therapeutics Pharmacokinetics and Drug Disposition: Use of Microdosing to Predict Pharmacokinetics at the Therapeutic dose: Experience with 5 drugs. Supported by the Consortium for Resourcing and Evaluating AMS Microdosing (CREAM) read more >> |
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| Quantification of Systemic Therapeutic Recombinant Protein by AMS Date Published: 01 Mar 2006 Journal of Pharmaceutical and Biomedical Analysis: Novel use of Accelerator Mass Spectrometry for the Quantification of Low Levels of Systemic Therapeutic Recombinant Protein. read more >> |
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