Related references
Note: Only part of the references are listed.Oxaliplatin-DNA Adducts as Predictive Biomarkers of FOLFOX Response in Colorectal Cancer: A Potential Treatment Optimization Strategy
Maike Zimmermann et al.
MOLECULAR CANCER THERAPEUTICS (2020)
Dynamic imaging in patients with tuberculosis reveals heterogeneous drug exposures in pulmonary lesions
Alvaro A. Ordonez et al.
NATURE MEDICINE (2020)
Application of a microdosed cocktail of 3 oral factor Xa inhibitors to study drug-drug interactions with different perpetrator drugs
Gerd Mikus et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2020)
Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma
Kenneth R. Gundle et al.
CLINICAL CANCER RESEARCH (2020)
How do the pharmacokinetics of drugs change in astronauts in space?
Sara Eyal
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY (2020)
Pilot Study to Predict Pharmacokinetics of a Therapeutic Gemcitabine Dose From a Microdose
M. Van Nuland et al.
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT (2020)
The endless frontier? The recent increase of R&D productivity in pharmaceuticals
Fabio Pammolli et al.
JOURNAL OF TRANSLATIONAL MEDICINE (2020)
Estimation of clinical trial success rates and related parameters
Chi Heem Wong et al.
BIOSTATISTICS (2019)
Probes and Cocktails for Drug-Drug Interaction Evaluation: The Future Is Microdosing?
Gerd Mikus
CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)
Predictive Value of Microdose Pharmacokinetics
Merel van Nuland et al.
CLINICAL PHARMACOKINETICS (2019)
Prediction of Human Nonlinear Pharmacokinetics of a New Bcl-2 Inhibitor Using PBPK Modeling and Interspecies Extrapolation Strategy
Philippe B. Pierrillas et al.
DRUG METABOLISM AND DISPOSITION (2019)
The biodistribution and clearance of AlbudAb, a novel biopharmaceutical medicine platform, assessed via PET imaging in humans
Kevin S. Thorneloe et al.
EJNMMI RESEARCH (2019)
Dose-linearity of the pharmacokinetics of an intravenous [14C]midazolam microdose in children
Bianca D. van Groen et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2019)
Simultaneous phenotyping of CYP2E1 and CYP3A using oral chlorzoxazone and midazolam microdoses
Nicolas Hohmann et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2019)
A Phase 0 Trial of Ribociclib in Recurrent Glioblastoma Patients Incorporating a Tumor Pharmacodynamic- and Pharmacokinetic-Guided Expansion Cohort
An-Chi Tien et al.
CLINICAL CANCER RESEARCH (2019)
Off-Label Prescribing in Children Remains High: A Call for Prioritized Research
Katelyn Yackey et al.
PEDIATRICS (2019)
Medications in Space: In Search of a Pharmacologist's Guide to the Galaxy
Sara Eyal et al.
PHARMACEUTICAL RESEARCH (2019)
Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients
Nader Sanai et al.
CLINICAL CANCER RESEARCH (2018)
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective
Mohamad Shebley et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2018)
Importance of target-mediated drug disposition for small molecules
Dennis A. Smith et al.
DRUG DISCOVERY TODAY (2018)
A Clinical Quantitative Evaluation of Hepatobiliary Transport of [11C] Dehydropravastatin in Humans Using Positron Emission Tomography
Ken-Ichi Kaneko et al.
DRUG METABOLISM AND DISPOSITION (2018)
Preclinical characterization of three transient receptor potential vanilloid receptor 1 antagonists for early use in human intradermal microdose analgesic studies
E. Sjogren et al.
EUROPEAN JOURNAL OF PAIN (2018)
Ultra-sensitive LC-MS/MS method for the quantification of gemcitabine and its metabolite 2′,2′-difluorodeoxyuridine in human plasma for a microdose clinical trial
M. van Nuland et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2018)
Developing a cassette microdosing approach to enhance the throughput of PET imaging agent screening
Hao Xiao et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2018)
Microdosing Cocktail Assay Development for Drug-Drug Interaction Studies
Cynthia M. Chavez-Eng et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2018)
Impact of a five-dimensional framework on R&D productivity at AstraZeneca
Paul Morgan et al.
NATURE REVIEWS DRUG DISCOVERY (2018)
Impact of target interactions on small-molecule drug disposition: an overlooked area
Robert A. B. van Waterschoot et al.
NATURE REVIEWS DRUG DISCOVERY (2018)
A Microdose PET Study of the Safety, Immunogenicity, Biodistribution, and Radiation Dosimetry of 18F-FB-A20FMDV2 for Imaging the Integrin αvβ6
Nicholas Keat et al.
JOURNAL OF NUCLEAR MEDICINE TECHNOLOGY (2018)
Phase 0, Including Microdosing Approaches: Applying the Three Rs and Increasing the Efficiency of Human Drug Development
Tal Burt et al.
ATLA-ALTERNATIVES TO LABORATORY ANIMALS (2018)
A human microdose study of the antimalarial drug GSK3191607 in healthy volunteers
Malek Okour et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2018)
Preclinical Characterization and Human Microdose Pharmacokinetics of ITMN-8187, a Nonmacrocyclic Inhibitor of the Hepatitis C Virus NS3 Protease
Ravi Rajagopalan et al.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY (2017)
Tumor-Specific Uptake of Fluorescent Bevacizumab-IRDye800CW Microdosing in Patients with Primary Breast Cancer: A Phase I Feasibility Study
Laetitia E. Lamberts et al.
CLINICAL CANCER RESEARCH (2017)
Validation of a Microdose Probe Drug Cocktail for Clinical Drug Interaction Assessments for Drug Transporters and CYP3A
T. Prueksaritanont et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2017)
Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - a practical guide
Tal Burt et al.
EXPERT OPINION ON DRUG DELIVERY (2017)
Small-Molecule Compounds Exhibiting Target-Mediated Drug Disposition (TMDD): A Minireview
Guohua An
JOURNAL OF CLINICAL PHARMACOLOGY (2017)
Microdose-Induced Drug-DNA Adducts as Biomarkers of Chemotherapy Resistance in Humans and Mice
Maike Zimmermann et al.
MOLECULAR CANCER THERAPEUTICS (2017)
Fluorescent Affibody Molecule Administered In Vivo at a Microdose Level Labels EGFR Expressing Glioma Tumor Regions
Ana Luiza Ribeiro de Souza et al.
MOLECULAR IMAGING AND BIOLOGY (2017)
Toxicity and Pharmacokinetic Profile for Single-Dose Injection of ABY-029: a Fluorescent Anti-EGFR Synthetic Affibody Molecule for Human Use
Kimberley S. Samkoe et al.
MOLECULAR IMAGING AND BIOLOGY (2017)
A diagnostic microdosing approach to investigate platinum sensitivity in non-small cell lung cancer
Si-Si Wang et al.
INTERNATIONAL JOURNAL OF CANCER (2017)
The Use of Microdosing in the Development of Small Organic and Protein Therapeutics
Mats Bergstrom
JOURNAL OF NUCLEAR MEDICINE (2017)
An ultra-sensitive LC-MS/MS method to determine midazolam levels in human plasma: development, validation and application to a clinical study
Mu Chen et al.
BIOANALYSIS (2017)
Drug-drug interaction of microdose and regular-dose omeprazole with a CYP2C19 inhibitor and inducer
Gab-Jin Park et al.
DRUG DESIGN DEVELOPMENT AND THERAPY (2017)
Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing
T. Burt et al.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2017)
Intra-Target Microdosing - A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans
T. Burt et al.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2017)
Comparison of pharmacokinetics of newly discovered aromatase inhibitors by a cassette microdosing approach in healthy Japanese subjects
Hiroyuki Kusuhara et al.
DRUG METABOLISM AND PHARMACOKINETICS (2017)
The Burden of the False-Negatives in Clinical Development: Analyses of Current and Alternative Scenarios and Corrective Measures
T. Burt et al.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2017)
Successful Use of [14C]Paracetamol Microdosing to Elucidate Developmental Changes in Drug Metabolism
Miriam G. Mooij et al.
CLINICAL PHARMACOKINETICS (2017)
Human microdosing and mice xenograft data of AGM-130 applied to estimate efficacious doses in patients
Wan-Su Park et al.
CANCER CHEMOTHERAPY AND PHARMACOLOGY (2017)
New methodologies for the preparation of carbon-11 labeled radiopharmaceuticals
Kenneth Dahl et al.
CLINICAL AND TRANSLATIONAL IMAGING (2017)
Validation of a liquid chromatography-triple quadrupole mass spectrometric method for the determination of 5-nitro-5-hydroxy-indirubin-3-oxime (AGM-130) in human plasma and its application to microdose clinical trial
Min-Ho Park et al.
BIOMEDICAL CHROMATOGRAPHY (2016)
To Apply Microdosing or Not? Recommendations to Single Out Compounds with Non-Linear Pharmacokinetics
Sieto Bosgra et al.
CLINICAL PHARMACOKINETICS (2016)
Mechanistic understanding of the nonlinear pharmacokinetics and intersubject variability of simeprevir: A PBPK-guided drug development approach
J. Snoeys et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2016)
Quantifying Carbon-14 for Biology Using Cavity Ring-Down Spectroscopy
A. Daniel McCartt et al.
ANALYTICAL CHEMISTRY (2016)
A phase 0 clinical trial of novel candidate extended-release formulations of capecitabine
Bart A. W. Jacobs et al.
CANCER CHEMOTHERAPY AND PHARMACOLOGY (2016)
Human Microdosing with Carcinogenic Polycyclic Aromatic Hydrocarbons: In Vivo Pharmacokinetics of Dibenzo[def,p]chrysene and Metabolites by UPLC Accelerator Mass Spectrometry
Erin P. Madeen et al.
CHEMICAL RESEARCH IN TOXICOLOGY (2016)
Parallel In Vivo Assessment of Drug Phenotypes at Various Time Points during Systemic BRAF Inhibition Reveals Tumor Adaptation and Altered Treatment Vulnerabilities
Oliver Jonas et al.
CLINICAL CANCER RESEARCH (2016)
Clinical Micro-Dose Studies to Explore the Human Pharmacokinetics of Four Selective Inhibitors of Human Nav1.7 Voltage-Dependent Sodium Channels
Hannah M. Jones et al.
CLINICAL PHARMACOKINETICS (2016)
Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development
T. Burt et al.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2016)
Innovation in the pharmaceutical industry: New estimates of R&D costs
Joseph A. DiMasi et al.
JOURNAL OF HEALTH ECONOMICS (2016)
Vision 20/20: Molecular-guided surgical oncology based upon tumor metabolism or immunologic phenotype: Technological pathways for point of care imaging and intervention
Brian W. Pogue et al.
MEDICAL PHYSICS (2016)
Microdose fluorescence imaging of ABY-029 on an operating microscope adapted by custom illumination and imaging modules
Jonathan T. Elliott et al.
BIOMEDICAL OPTICS EXPRESS (2016)
Pharmacokinetic, Dosimetry and Toxicity Study of 177Lu-EDTMP in Patients: Phase 0/I Study
Chandrasekhar Bal et al.
CURRENT RADIOPHARMACEUTICALS (2016)
The Prediction of the Relative Importance of CYP3A/P-glycoprotein to the Nonlinear Intestinal Absorption of Drugs by Advanced Compartmental Absorption and Transit Model
Junichi Takano et al.
DRUG METABOLISM AND DISPOSITION (2016)
Midazolam microdose to determine systemic and pre-systemic metabolic CYP3A activity in humans
Nicolas Hohmann et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2015)
Observational infant exploratory [14C]-paracetamol pharmacokinetic microdose/therapeutic dose study with accelerator mass spectrometry bioanalysis
Colin R. Garner et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2015)
A clinical pharmacokinetic microdosing study of docetaxel with Japanese patients with cancer
Ken-ichi Fujita et al.
CANCER CHEMOTHERAPY AND PHARMACOLOGY (2015)
Pediatric Microdose and Microtracer Studies Using 14C in Europe
M. A. Turner et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Microdosing Studies in Children: A US Regulatory Perspective
M. Roth-Cline et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Microdosing of a Carbon-14 Labeled Protein in Healthy Volunteers Accurately Predicts Its Pharmacokinetics at Therapeutic Dosages
M. L. H. Vlaming et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology
Michelle Roth-Cline et al.
CURRENT PHARMACEUTICAL DESIGN (2015)
EANM’15
EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING (2015)
Large Variation in Brain Exposure of Reference CNS Drugs: a PET Study in Nonhuman Primates
Magnus Schou et al.
INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY (2015)
Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats
Tal Burt et al.
JOURNAL OF NUCLEAR MEDICINE (2015)
An Assessment of the Oral Bioavailability of Three Ca-Channel Blockers Using a Cassette-Microdose Study: A New Strategy for Streamlining Oral Drug Development
Shinji Yamashita et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2015)
Why is it hard to terminate failing projects in pharmaceutical R&D?
Richard W. Peck et al.
NATURE REVIEWS DRUG DISCOVERY (2015)
Progression-seeking bias and rational optimism in research and development
Dennis W. Lendrem et al.
NATURE REVIEWS DRUG DISCOVERY (2015)
The Cost of Drug Development
Joseph A. DiMasi et al.
NEW ENGLAND JOURNAL OF MEDICINE (2015)
Development of rapid multistep carbon-11 radiosynthesis of the myeloperoxidase inhibitor AZD3241 to assess brain exposure by PET microdosing
Peter Johnstrom et al.
NUCLEAR MEDICINE AND BIOLOGY (2015)
An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors
Oliver Jonas et al.
SCIENCE TRANSLATIONAL MEDICINE (2015)
Lapatinib access into normal brain and brain metastases in patients with Her-2 overexpressing breast cancer
Azeem Saleem et al.
EJNMMI RESEARCH (2015)
Human in Vivo Pharmacokinetics of [14C]Dibenzo[def,p]chrysene by Accelerator Mass Spectrometry Following Oral Microdosing
Erin Madeen et al.
CHEMICAL RESEARCH IN TOXICOLOGY (2015)
A decade of innovation in pharmaceutical R&D: the Chorus model
Paul K. Owens et al.
NATURE REVIEWS DRUG DISCOVERY (2015)
Modulation of P-glycoprotein at the Human Blood-Brain Barrier by Quinidine or Rifampin Treatment: A Positron Emission Tomography Imaging Study
Li Liu et al.
DRUG METABOLISM AND DISPOSITION (2015)
Use of Microdosing and Accelerator Mass Spectrometry To Evaluate the Pharmacokinetic Linearity of a Novel Tricyclic GyrB/ParE Inhibitor in Rats
Michael A. Malfatti et al.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY (2014)
Pediatric Microdose Study of [14C] Paracetamol to Study Drug Metabolism Using Accelerated Mass Spectrometry: Proof of Concept
Miriam G. Mooij et al.
CLINICAL PHARMACOKINETICS (2014)
Response to Can CYP3A Activity Be Evaluated for Drug Interaction Using a Nanogram Dose of Probe Drug?: Evaluation of CYP3A Activity With Microdoses of Midazolam
N. Hohmann et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2014)
Preclinical evaluation of BAY 1075553, a novel 18F-labelled inhibitor of prostate-specific membrane antigen for PET imaging of prostate cancer
Ralf Lesche et al.
EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING (2014)
Pharmacokinetic analysis of 14C-ursodiol in newborn infants using accelerator mass spectrometry
Toufigh Gordi et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2014)
Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework
David Cook et al.
NATURE REVIEWS DRUG DISCOVERY (2014)
Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital
Jennifer R. Bellis et al.
BMC MEDICINE (2013)
First-in-Human Phase 0 Trial of Oral 5-Iodo-2-Pyrimidinone-2′-Deoxyribose in Patients with Advanced Malignancies
Shivaani Kummar et al.
CLINICAL CANCER RESEARCH (2013)
A Nanogram Dose of the CYP3A Probe Substrate Midazolam to Evaluate Drug Interactions
B. Halama et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2013)
Cost-effectiveness Analysis of Microdose Clinical Trials in Drug Development
Naoe Yamane et al.
DRUG METABOLISM AND PHARMACOKINETICS (2013)
A microdose study of 14C-AR-709 in healthy men: pharmacokinetics, absolute bioavailability and concentrations in key compartments of the lung
G. Lappin et al.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2013)
Microdose pharmacogenetic study of 14C-tolbutamide in healthy subjects with accelerator mass spectrometry to examine the effects of CYP2C9*3 on its pharmacokinetics and metabolism
Toshihiko Ikeda et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2013)
AFN-1252 in vitro absorption studies and pharmacokinetics following microdosing in healthy subjects
Nachum Kaplan et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2013)
Microdosing and drug development: past, present and future
Graham Lappin et al.
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY (2013)
Mechanisms of Pharmacokinetic Enhancement Between Ritonavir and Saquinavir; Micro/Small Dosing Tests Using Midazolam (CYP3A4), Fexofenadine (p-Glycoprotein), and Pravastatin (OATP1B1) as Probe Drugs
Ichiro Ieiri et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2013)
Phase 0 Microdosing PET Study Using the Human Mini Antibody F16SIP in Head and Neck Cancer Patients
Derrek A. Heuveling et al.
JOURNAL OF NUCLEAR MEDICINE (2013)
High-sensitive LC-MS/MS method for the simultaneous determination of mirodenafil and its major metabolite, SK-3541, in human plasma: Application to microdose clinical trials of mirodenafil
Doo-Yeoun Cho et al.
JOURNAL OF SEPARATION SCIENCE (2013)
Power failure: why small sample size undermines the reliability of neuroscience
Katherine S. Button et al.
NATURE REVIEWS NEUROSCIENCE (2013)
Radiolabeling of the cannabinoid receptor agonist AZD1940 with carbon-11 and PET microdosing in non-human primate
Magnus Schou et al.
NUCLEAR MEDICINE AND BIOLOGY (2013)
Iodine-129 microdosing for protein and peptide drug development: erythropoietin as a case study
Robert-Jan A. N. Lamers et al.
BIOANALYSIS (2013)
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
Anthony Cahn et al.
BMC PHARMACOLOGY & TOXICOLOGY (2013)
Positron Emission Tomography as a Method for Measuring Drug Delivery to Tumors in vivo: The Example of [C-11]docetaxel.
Astrid A. M. van der Veldt et al.
FRONTIERS IN ONCOLOGY (2013)
Quantification of femtomolar concentrations of the CYP3A substrate midazolam and its main metabolite 1'-hydroxymidazolam in human plasma using ultra performance liquid chromatography coupled to tandem mass spectrometry
Juergen Burhenne et al.
ANALYTICAL AND BIOANALYTICAL CHEMISTRY (2012)
Ultrasensitive Liquid Chromatography-Tandem Mass Spectrometric Methodologies for Quantification of Five HIV-1 Integrase Inhibitors in Plasma for a Microdose Clinical Trial
Li Sun et al.
ANALYTICAL CHEMISTRY (2012)
Human microdose evaluation of the novel EP1 receptor antagonist GSK269984A
Thor Ostenfeld et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2012)
Predicting Drug Candidate Victims of Drug-Drug Interactions, using Microdosing
Marie Croft et al.
CLINICAL PHARMACOKINETICS (2012)
Pgp-Mediated Interaction Between (R)-[11C]Verapamil and Tariquidar at the Human Blood-Brain Barrier: A Comparison With Rat Data
M. Bauer et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2012)
Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival
Paul Morgan et al.
DRUG DISCOVERY TODAY (2012)
A positron emission tomography microdosing study with sertraline in healthy volunteers
Kwang-Hee Shin et al.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS (2012)
Pharmacogenomic/pharmacokinetic assessment of a four-probe cocktail for CYPs and OATPs following oral microdosing
Ichiro Ieiri et al.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS (2012)
Biphasic Elimination of Tenofovir Diphosphate and Nonlinear Pharmacokinetics of Zidovudine Triphosphate in a Microdosing Study
Jianmeng Chen et al.
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES (2012)
Combining PET biodistribution and equilibrium dialysis assays to assess the free brain concentration and BBB transport of CNS drugs
Roger N. Gunn et al.
JOURNAL OF CEREBRAL BLOOD FLOW AND METABOLISM (2012)
Microdosing Clinical Study: Pharmacokinetic, Pharmacogenomic (SLCO2B1), and Interaction (Grapefruit Juice) Profiles of Celiprolol Following the Oral Microdose and Therapeutic Dose
Ichiro Ieiri et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2012)
PET Imaging Based Evaluation of Hepatobiliary Transport in Humans with (15R)-11C-TIC-Me
Tadayuki Takashima et al.
JOURNAL OF NUCLEAR MEDICINE (2012)
Microdosing: A critical assessment of human data
Malcolm Rowland
JOURNAL OF PHARMACEUTICAL SCIENCES (2012)
Diagnosing the decline in pharmaceutical R&D efficiency
Jack W. Scannell et al.
NATURE REVIEWS DRUG DISCOVERY (2012)
Case studies addressing human pharmacokinetic uncertainty using a combination of pharmacokinetic simulation and alternative first in human paradigms
Anthony Harrison et al.
XENOBIOTICA (2012)
Applications of accelerator MS in pediatric drug evaluation
L. T. Vuong et al.
BIOANALYSIS (2012)
PET imaging for receptor occupancy: meditations on calculation and simplification
Yumin Zhang et al.
JOURNAL OF BIOMEDICAL RESEARCH (2012)
Evaluation of Physical and Chemical Changes in Pharmaceuticals Flown on Space Missions
Brian Du et al.
AAPS JOURNAL (2011)
Impact of microdosing clinical study - Why necessary and how useful?
Yuichi Sugiyama et al.
ADVANCED DRUG DELIVERY REVIEWS (2011)
Ethical, legal, and social implications (ELSI) of microdose clinical trials
Chieko Kurihara
ADVANCED DRUG DELIVERY REVIEWS (2011)
Novel strategies for microdose studies using non-radiolabeled compounds
Kazuya Maeda et al.
ADVANCED DRUG DELIVERY REVIEWS (2011)
Quantifying exploratory low dose compounds in humans with AMS
Stephen R. Dueker et al.
ADVANCED DRUG DELIVERY REVIEWS (2011)
Approaches using molecular imaging technology - use of PET in clinical microdose studies
Claudia C. Wagner et al.
ADVANCED DRUG DELIVERY REVIEWS (2011)
Phase 0 Clinical Chemoprevention Trial of the Akt Inhibitor SR13668
Joel M. Reid et al.
CANCER PREVENTION RESEARCH (2011)
A Combined Accelerator Mass Spectrometry-Positron Emission Tomography Human Microdose Study with C-14- and C-11-Labelled Verapamil
Claudia C. Wagner et al.
CLINICAL PHARMACOKINETICS (2011)
Nonlinear Pharmacokinetics of Oral Quinidine and Verapamil in Healthy Subjects: A Clinical Microdosing Study
K. Maeda et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Effects of a MATE Protein Inhibitor, Pyrimethamine, on the Renal Elimination of Metformin at Oral Microdose and at Therapeutic Dose in Healthy Subjects
H. Kusuhara et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Identification of the Rate-Determining Process in the Hepatic Clearance of Atorvastatin in a Clinical Cassette Microdosing Study
K. Maeda et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Individualized quantification of brain β-amyloid burden: results of a proof of mechanism phase 0 florbetaben PET trial in patients with Alzheimer's disease and healthy controls
Henryk Barthel et al.
EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING (2011)
Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers
Graham Lappin et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2011)
The cost of drug development: A systematic review
Steve Morgan et al.
HEALTH POLICY (2011)
A microdosing approach for characterizing formation and repair of carboplatin-DNA monoadducts and chemoresistance
Paul T. Henderson et al.
INTERNATIONAL JOURNAL OF CANCER (2011)
Lead PK Commentary: Predicting Human Pharmacokinetics
Malcolm Rowland et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2011)
A highly sensitive LC-MS/MS method capable of simultaneously quantitating celiprolol and atenolol in human plasma for a cassette cold-microdosing study
Yoshiyuki Minamide et al.
JOURNAL OF SEPARATION SCIENCE (2011)
How were new medicines discovered?
David C. Swinney et al.
NATURE REVIEWS DRUG DISCOVERY (2011)
The productivity crisis in pharmaceutical R&D
Fabio Pammolli et al.
NATURE REVIEWS DRUG DISCOVERY (2011)
Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs
Julia Dunne et al.
PEDIATRICS (2011)
Clinical Relevance of Liquid Chromatography Tandem Mass Spectrometry as an Analytical Method in Microdose Clinical Studies
Naoe Yamane et al.
PHARMACEUTICAL RESEARCH (2011)
Pharmacokinetic and pharmacogenomic profiles of telmisartan after the oral microdose and therapeutic dose
Ichiro Ieiri et al.
PHARMACOGENETICS AND GENOMICS (2011)
Radiopharmaceutical chemistry for positron emission tomography
Zibo Li et al.
ADVANCED DRUG DELIVERY REVIEWS (2010)
The novel benzopyran class of selective cyclooxygenase-2 inhibitors. Part III: The three microdose candidates
Jane L. Wang et al.
BIOORGANIC & MEDICINAL CHEMISTRY LETTERS (2010)
Microdose Study of 14C-Acetaminophen With Accelerator Mass Spectrometry to Examine Pharmacokinetics of Parent Drug and Metabolites in Healthy Subjects
Z. Tozuka et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2010)
Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs
J. A. DiMasi et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2010)
Pharmacokinetics of fexofenadine: Evaluation of a microdose and assessment of absolute oral bioavailability
Graham Lappin et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2010)
Microdose study of a P-glycoprotein substrate, fexofenadine, using a non-radioisotope-labelled drug and LC/MS/MS
A. Yamazaki et al.
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS (2010)
Pharmacodynamic (Phase 0) Study Using Etaracizumab in Advanced Melanoma
Stergios J. Moschos et al.
JOURNAL OF IMMUNOTHERAPY (2010)
How to improve R&D productivity: the pharmaceutical industry's grand challenge
Steven M. Paul et al.
NATURE REVIEWS DRUG DISCOVERY (2010)
Microdosing for early biokinetic studies in humans
K. Stenstrom et al.
RADIATION PROTECTION DOSIMETRY (2010)
Human microdosing for the prediction of patient response
Paul T. Henderson et al.
BIOANALYSIS (2010)
Sensitivity and proportionality assessment of metabolites from microdose to high dose in rats using LC-MS/MS
Jinsong Ni et al.
BIOANALYSIS (2010)
Practical experience of using human microdosing with AMS analysis to obtain early human drug metabolism and PK data
R. Colin Garner
BIOANALYSIS (2010)
Early human ADME using microdoses and microtracers: bioanalytical considerations
Stephen R. Dueker et al.
BIOANALYSIS (2010)
Prediction of Hepatic Clearance in Human From In Vitro Data for Successful Drug Development
Masato Chiba et al.
AAPS JOURNAL (2009)
A pharmacokinetic evaluation of five H1 antagonists after an oral and intravenous microdose to human subjects
Ajay Madan et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2009)
Effective Use of Microdosing and Positron Emission Tomography (PET) Studies on New Drug Discovery and Development
Yuichi Sugiyama
DRUG METABOLISM AND PHARMACOKINETICS (2009)
Microdose Clinical Trial: Quantitative Determination of Nicardipine and Prediction of Metabolites in Human Plasma
Naoe Yamane et al.
DRUG METABOLISM AND PHARMACOKINETICS (2009)
Phase 0 Clinical Trial of the Poly (ADP-Ribose) Polymerase Inhibitor ABT-888 in Patients With Advanced Malignancies
Shivaani Kummar et al.
JOURNAL OF CLINICAL ONCOLOGY (2009)
Microdose Pharmacokinetics of IDX899 and IDX989, Candidate HIV-1 Non-Nucleoside Reverse Transcriptase Inhibitors, Following Oral and Intravenous Administration in Healthy Male Subjects
Xiao-Jian Zhou et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2009)
Lessons from 60 years of pharmaceutical innovation
Bernard Munos
NATURE REVIEWS DRUG DISCOVERY (2009)
Traversing the Valley of Death: A Guide to Assessing Prospects for Translational Success
Barry S. Coller et al.
SCIENCE TRANSLATIONAL MEDICINE (2009)
Use of accelerator mass spectrometry to measure the pharmacokinetics and peripheral blood mononuclear cell concentrations of zidovudine
Le T. Vuong et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2008)
Microdosing studies in humans - The role of positron emission tomography
Martin Bauer et al.
DRUGS IN R&D (2008)
Plasma pharmacokinetic evaluation of cytotoxic agents radiolabelled with positron emitting radioisotopes
A. Saleem et al.
CANCER CHEMOTHERAPY AND PHARMACOLOGY (2008)
Commentary on ACCP position statement on the use of microdosing in the drug development process
Malcolm Rowland
JOURNAL OF CLINICAL PHARMACOLOGY (2007)
Ethics at phase 0: Clarifying the issues
Jonathan Kimmelman
JOURNAL OF LAW MEDICINE & ETHICS (2007)
Characterization of oxaliplatin-DNA adduct formation in DNA and differentiation of cancer cell drug sensitivity at microdose concentrations
Sang Soo Hah et al.
CHEMICAL RESEARCH IN TOXICOLOGY (2007)
2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N(methylsulfonyl)acetamide (NS-304), an orally available and long-acting prostacyclin receptor agonist prodrug
Keiichi Kuwano et al.
JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS (2007)
Use of microdosing to predict pharmacokinetics at the therapeutic dose: Experience with 5 drugs
Graham Lappin et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2006)
A positron emission tomography microdosing study with a potential antiamyloid drug in healthy volunteers and patients with Alzheimer's disease
Martin Bauer et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2006)
Using positron emission tomography to facilitate CNS drug development
Chi-Ming Lee et al.
TRENDS IN PHARMACOLOGICAL SCIENCES (2006)
Cocktail approaches and strategies in drug development: Valuable tool or flawed science?
HH Zhou et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2004)
Whatever happened to cassette-dosing pharmacokinetics?
P Manitpisitkul et al.
DRUG DISCOVERY TODAY (2004)
Evaluation of microdosing strategies for studies in preclinical drug development: Demonstration of linear pharmacokinetics in dogs of a nucleoside analog over a 50-fold dose range
P Sandhu et al.
DRUG METABOLISM AND DISPOSITION (2004)
Positron emission tomography microdosing:: a new concept with application in tracer and early clinical drug development
M Bergström et al.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2003)
Big physics, small doses: the use of AMS and PET in human microdosing of development drugs
G Lappin et al.
NATURE REVIEWS DRUG DISCOVERY (2003)
The price of innovation: new estimates of drug development costs
JA DiMasi et al.
JOURNAL OF HEALTH ECONOMICS (2003)
General pharmacokinetic model for drugs exhibiting target-mediated drug disposition
DE Mager et al.
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS (2001)
Accelerator mass spectrometry (AMS): recent experience of its use in a clinical study and the potential future of the technique
G Young et al.
XENOBIOTICA (2001)
Pharmacokinetic evaluation of N-[2(dimethylamino)ethyl]acridine-4-carboxamide in patients by positron emission tomography
A Saleem et al.
JOURNAL OF CLINICAL ONCOLOGY (2001)
Share Paper
