Human absorption, distribution, metabolism and excretion properties of drug molecules: a plethora of approaches

Concomitant oral and intravenous pharmacokinetics of trametinib, a MEK inhibitor, in subjects with solid tumours

(2014) Cathrine Leonowens et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Sensitivity-based analytical approaches to support human absolute bioavailability studies

(2014) Xiaohui (Sophia) Xu et al.   Bioanalysis

A Novel Double-Tracer Technique to Characterize Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]Tofogliflozin After Oral Administration and Concomitant Intravenous Microdose Administration of [13C]Tofogliflozin in Humans

(2013) Dietmar Schwab et al.   CLINICAL PHARMACOKINETICS

Addressing MIST (Metabolites in Safety Testing): Bioanalytical Approaches to Address Metabolite Exposures in Humans and Animals

(2013) Hongying Gao et al.   CURRENT DRUG METABOLISM

PBPK models for the prediction of in vivo performance of oral dosage forms

(2013) Edmund S. Kostewicz et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Microdosing and drug development: past, present and future

(2013) Graham Lappin et al.   Expert Opinion on Drug Metabolism & Toxicology

Bioavailability, metabolism and disposition of oral pazopanib in patients with advanced cancer

(2013) Yanli Deng et al.   XENOBIOTICA

Trametinib, a first-in-class oral MEK inhibitor mass balance study with limited enrollment of two male subjects with advanced cancers

(2013) May Y. K. Ho et al.   XENOBIOTICA

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633, a CC-chemokine receptor 4 antagonist, in healthy male subjects: results from an open-label and from a randomised study

(2013) Anthony Cahn et al.   BMC Pharmacology & Toxicology

Practical and Efficient Strategy for Evaluating Oral Absolute Bioavailability with an Intravenous Microdose of a Stable Isotopically-Labeled Drug Using a Selected Reaction Monitoring Mass Spectrometry Assay

(2012) Hao Jiang et al.   ANALYTICAL CHEMISTRY

Human microdose evaluation of the novel EP1 receptor antagonist GSK269984A

(2012) Thor Ostenfeld et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Assessment of potential drug interactions by characterization of human drug metabolism pathways using non-invasive bile sampling

(2012) Jackie C. Bloomer et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Microdosing: A Critical Assessment of Human Data

(2012) Malcolm Rowland   JOURNAL OF PHARMACEUTICAL SCIENCES

Use of Entero-Test, a simple approach for non-invasive clinical evaluation of the biliary disposition of drugs

(2011) William J. Guiney et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers

(2011) Graham Lappin et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

PhRMA CPCDC Initiative on Predictive Models of Human Pharmacokinetics, Part 1: Goals, Properties of the Phrma Dataset, and Comparison with Literature Datasets

(2011) Patrick Poulin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 4: Prediction of plasma concentration–time profiles in human from in vivo preclinical data by using the Wajima approach

(2011) Ragini Vuppugalla et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration–time profiles in human by using the physiologically‐based pharmacokinetic modeling approach

(2011) Patrick Poulin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: Comparative assessement of prediction methods of human clearance

(2011) Barbara J. Ring et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: Comparative assessment of prediction methods of human volume of distribution

(2011) Rhys Do Jones et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

From definition to implementation: a cross-industry perspective of past, current and future MIST strategies

(2011) Angus N.R. Nedderman et al.   XENOBIOTICA

Case studies addressing human pharmacokinetic uncertainty using a combination of pharmacokinetic simulation and alternative first in human paradigms

(2011) Anthony Harrison et al.   XENOBIOTICA

Approaches for the rapid identification of drug metabolites in early clinical studies

(2011) Gordon J Dear et al.   Bioanalysis

Novel MS solutions inspired by MIST

(2010) Ragu Ramanathan et al.   Bioanalysis

Human radiolabeled mass balance studies: objectives, utilities and limitations

(2009) Natalia Penner et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Obtaining Exposures of Metabolites in Preclinical Species through Plasma Pooling and Quantitative NMR: Addressing Metabolites in Safety Testing (MIST) Guidance without Using Radiolabeled Compounds and Chemically Synthesized Metabolite Standards

(2008) Karthick Vishwanathan et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Metabolism and Disposition of Fluticasone Furoate, an Enhanced-Affinity Glucocorticoid, in Humans

(2008) S. C. Hughes et al.   DRUG METABOLISM AND DISPOSITION

Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokinetics

(2008) Graham Lappin et al.   Expert Opinion on Drug Metabolism & Toxicology

Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma

(2008) G.J. Dear et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES