Microdosing and drug development: past, present and future

Calculation and Mitigation of Isotopic Interferences in Liquid Chromatography–Mass Spectrometry/Mass Spectrometry Assays and Its Application in Supporting Microdose Absolute Bioavailability Studies

(2012) Huidong Gu et al.   ANALYTICAL CHEMISTRY

Ultrasensitive Liquid Chromatography–Tandem Mass Spectrometric Methodologies for Quantification of Five HIV-1 Integrase Inhibitors in Plasma for a Microdose Clinical Trial

(2012) Li Sun et al.   ANALYTICAL CHEMISTRY

Human microdose evaluation of the novel EP1 receptor antagonist GSK269984A

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

Predicting Drug Candidate Victims of Drug-Drug Interactions, using Microdosing

(2012) Marie Croft et al.   CLINICAL PHARMACOKINETICS

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Pharmacogenomic/pharmacokinetic assessment of a four-probe cocktail for CYPs and OATPs following oral microdosing

(2012) Ichiro Ieiri et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Biphasic Elimination of Tenofovir Diphosphate and Nonlinear Pharmacokinetics of Zidovudine Triphosphate in a Microdosing Study

(2012) Jianmeng Chen et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Microdosing: A Critical Assessment of Human Data

(2012) Malcolm Rowland   JOURNAL OF PHARMACEUTICAL SCIENCES

Applications of accelerator MS in pediatric drug evaluation

(2012) LT Vuong et al.   Bioanalysis

BDDCS Applied to Over 900 Drugs

(2011) Leslie Z. Benet et al.   AAPS Journal

Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials

(2011) Soo Kyung Bae et al.   ARCHIVES OF PHARMACAL RESEARCH

Nonlinear Pharmacokinetics of Oral Quinidine and Verapamil in Healthy Subjects: A Clinical Microdosing Study

(2011) K Maeda et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Effects of a MATE Protein Inhibitor, Pyrimethamine, on the Renal Elimination of Metformin at Oral Microdose and at Therapeutic Dose in Healthy Subjects

(2011) H Kusuhara et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Identification of the Rate-Determining Process in the Hepatic Clearance of Atorvastatin in a Clinical Cassette Microdosing Study

(2011) K Maeda et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

Lead PK Commentary: Predicting Human Pharmacokinetics

(2011) Malcolm Rowland et al.   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

Clinical Relevance of Liquid Chromatography Tandem Mass Spectrometry as an Analytical Method in Microdose Clinical Studies

(2011) Naoe Yamane et al.   PHARMACEUTICAL RESEARCH

Prediction of Nonlinear Intestinal Absorption of CYP3A4 and P-Glycoprotein Substrates from their In Vitro Km Values

(2011) Tatsuhiko Tachibana et al.   PHARMACEUTICAL RESEARCH

Pharmacokinetic and pharmacogenomic profiles of telmisartan after the oral microdose and therapeutic dose

(2011) Ichiro Ieiri et al.   Pharmacogenetics and Genomics

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

(2011) Anthony Harrison et al.   XENOBIOTICA

The novel benzopyran class of selective cyclooxygenase-2 inhibitors. Part III: The three microdose candidates

(2010) Jane L. Wang et al.   BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

A Combined Accelerator Mass Spectrometry-Positron Emission Tomography Human Microdose Study with 14C- and 11C-Labelled Verapamil

(2010) Claudia C. Wagner et al.   CLINICAL PHARMACOKINETICS

Accelerator Mass Spectrometry Measurement of Intracellular Concentrations of Active Drug Metabolites in Human Target Cells In Vivo

(2010) J Chen et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Biotransformation Profiling of [14C]Ixabepilone in Human Plasma, Urine and Feces Samples Using Accelerator Mass Spectrometry (AMS)

(2010) S. Nilgün Çömezoğlu et al.   Drug Metabolism and Pharmacokinetics

Microdose study of a P-glycoprotein substrate, fexofenadine, using a non-radioisotope-labelled drug and LC/MS/MS

(2010) A. Yamazaki et al.   JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS

Interview: Interview with Professor Malcolm Rowland

(2010) Malcolm Rowland   Bioanalysis

Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development

(2010) Berend Oosterhuis   Bioanalysis

Microdosing: current and the future

(2010) Graham Lappin   Bioanalysis

Single-Dose Escalation and Multiple-Dose Safety, Tolerability, and Pharmacokinetics of IDX899, a Candidate Human Immunodeficiency Virus Type 1 Nonnucleoside Reverse Transcriptase Inhibitor, in Healthy Subjects

(2009) X.-J. Zhou et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

A pharmacokinetic evaluation of five H1antagonists after an oral and intravenous microdose to human subjects

(2009) Ajay Madan et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Effective Use of Microdosing and Positron Emission Tomography (PET) Studies on New Drug Discovery and Development

(2009) Yuichi Sugiyama   Drug Metabolism and Pharmacokinetics

Microdose Clinical Trial: Quantitative Determination of Nicardipine and Prediction of Metabolites in Human Plasma

(2009) Naoe Yamane et al.   Drug Metabolism and Pharmacokinetics

Phase 0 Clinical Trial of the Poly (ADP-Ribose) Polymerase Inhibitor ABT-888 in Patients With Advanced Malignancies

(2009) Shivaani Kummar et al.   JOURNAL OF CLINICAL ONCOLOGY

Microdose Pharmacokinetics of IDX899 and IDX989, Candidate HIV-1 Non-Nucleoside Reverse Transcriptase Inhibitors, Following Oral and Intravenous Administration in Healthy Male Subjects

(2009) Xiao-Jian Zhou et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Microdosing: a valuable tool for accelerating drug development and the role of bioanalytical methods in meeting the challenge

(2009) Robert MJ Ings   Bioanalysis

New ultrasensitive detection technologies and techniques for use in microdosing studies

(2009) Graham Lappin et al.   Bioanalysis

Subattomole Sensitivity in Biological Accelerator Mass Spectrometry

(2008) Mehran Salehpour et al.   ANALYTICAL CHEMISTRY

The Development of Phase I Cancer Trial Methodologies: the Use of Pharmacokinetic and Pharmacodynamic End Points Sets the Scene for Phase 0 Cancer Clinical Trials

(2008) A. H. Calvert et al.   CLINICAL CANCER RESEARCH

The utility of microdosing over the past 5 years

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

Microdosing Assessment to Evaluate Pharmacokinetics and Drug Metabolism in Rats Using Liquid Chromatography-Tandem Mass Spectrometry

(2008) Jinsong Ni et al.   PHARMACEUTICAL RESEARCH

Use of Accelerator Mass Spectrometry to Measure the Pharmacokinetics and Peripheral Blood Mononuclear Cell Concentrations of Zidovudine

(2007) Le T. Vuong et al.   JOURNAL OF PHARMACEUTICAL SCIENCES