Dose adjustment in orphan disease populations: the quest to fulfill the requirements of physiologically based pharmacokinetics

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

(2018) Mohamad Shebley et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically based pharmacokinetic modelling to guide drug delivery in older people

(2018) Manoranjenni Chetty et al.   ADVANCED DRUG DELIVERY REVIEWS

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group

(2017) Stuart M. Lichtman et al.   JOURNAL OF CLINICAL ONCOLOGY

Challenges and Opportunities with Non-CYP Enzymes Aldehyde Oxidase, Carboxylesterase, and UDP-Glucuronosyltransferase: Focus on Reaction Phenotyping and Prediction of Human Clearance

(2016) Upendra A. Argikar et al.   AAPS Journal

Ontogeny of Hepatic Drug Transporters as Quantified by LC-MS/MS Proteomics

(2016) B Prasad et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Dosage Adjustments Related to Young or Old Age and Organ Impairment

(2016) James F. Burris et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

(2016) Islam R. Younis et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetic drug interactions in liver disease: An update

(2016) Pietro Palatini   WORLD JOURNAL OF GASTROENTEROLOGY

Abnormal laboratory results: Therapeutic drug monitoring: which drugs, why, when and how to do it

(2016) RA Ghiculesco   Australian Prescriber

Population pharmacokinetics: an overview

(2016) Bruce Charles   Australian Prescriber

Paediatric pharmacokinetics: key considerations

(2015) Hannah Katharine Batchelor et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Human Ontogeny of Drug Transporters: Review and Recommendations of the Pediatric Transporter Working Group

(2015) KLR Brouwer et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Translational value of liquid chromatography coupled with tandem mass spectrometry-based quantitative proteomics forin vitro–in vivoextrapolation of drug metabolism and transport and considerations in selecting appropriate techniques

(2015) Hajar Al Feteisi et al.   Expert Opinion on Drug Metabolism & Toxicology

Influence of multidrug resistance and drug transport proteins on chemotherapy drug metabolism

(2015) Helena Joyce et al.   Expert Opinion on Drug Metabolism & Toxicology

Ten years of QconCATs: Application of multiplexed quantification to small medically relevant proteomes

(2015) Brahim Achour et al.   INTERNATIONAL JOURNAL OF MASS SPECTROMETRY

A proposal for scientific framework enabling specific population drug dosing recommendations

(2015) Pravin R. Jadhav et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Meta-analysis of hepatic cytochrome P450 ontogeny to underwrite the prediction of pediatric pharmacokinetics using physiologically based pharmacokinetic modeling

(2015) Vijay V. Upreti et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Biliary Atresia

(2015) Amy G. Feldman et al.   JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION

An analysis of the attrition of drug candidates from four major pharmaceutical companies

(2015) Michael J. Waring et al.   NATURE REVIEWS DRUG DISCOVERY

Pharmacometrics in Pregnancy: An Unmet Need

(2014) Alice Ban Ke et al.   Annual Review of Pharmacology and Toxicology

Drug metabolism for the paediatrician

(2014) S. N. de Wildt et al.   ARCHIVES OF DISEASE IN CHILDHOOD

Dosing in Children: A Critical Review of the Pharmacokinetic Allometric Scaling and Modelling Approaches in Paediatric Drug Development and Clinical Settings

(2014) Iftekhar Mahmood   CLINICAL PHARMACOKINETICS

Phase 0 and phase III transport in various organs: Combined concept of phases in xenobiotic transport and metabolism

(2014) Barbara Döring et al.   DRUG METABOLISM REVIEWS

Drug disposition alterations in liver disease: extrahepatic effects in cholestasis and nonalcoholic steatohepatitis

(2014) Mark J Canet et al.   Expert Opinion on Drug Metabolism & Toxicology

Quantification of the Proteins of the Bacterial Ribosome Using QconCAT Technology

(2014) Zubida M. Al-Majdoub et al.   JOURNAL OF PROTEOME RESEARCH

Clinical development success rates for investigational drugs

(2014) Michael Hay et al.   NATURE BIOTECHNOLOGY

Effects of age at Kasai portoenterostomy on the surgical outcome: a review of the literature

(2014) Masaki Nio et al.   SURGERY TODAY

Human Hepatic UGT2B15 Developmental Expression

(2014) Karthika Divakaran et al.   TOXICOLOGICAL SCIENCES

Hepatic inflammation and progressive liver fibrosis in chronic liver disease

(2014) Albert J Czaja   WORLD JOURNAL OF GASTROENTEROLOGY

Pediatric non-alcoholic fatty liver disease: Recent advances

(2014) Claudia Della Corte et al.   Clinics and Research in Hepatology and Gastroenterology

Review article: prescribing medications in patients with cirrhosis - a practical guide

(2013) J. H. Lewis et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Role of Nrf2 in Oxidative Stress and Toxicity

(2013) Qiang Ma   Annual Review of Pharmacology and Toxicology

Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19

(2013) Alice Ban Ke et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Tricyclic Antidepressants

(2013) J K Hicks et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Alternative Fusion Protein Strategies to Express Recalcitrant QconCAT Proteins for Quantitative Proteomics of Human Drug Metabolizing Enzymes and Transporters

(2013) Matthew R. Russell et al.   JOURNAL OF PROTEOME RESEARCH

Disease, Drug Metabolism, and Transporter Interactions

(2013) Jeffrey L. Staudinger   PHARMACEUTICAL RESEARCH

Clues to the Etiology of Bile Duct Injury in Biliary Atresia

(2013) Cara Mack et al.   SEMINARS IN LIVER DISEASE

Covariate Pharmacokinetic Model Building in Oncology and its Potential Clinical Relevance

(2012) Markus Joerger   AAPS Journal

Physiologically Based Pharmacokinetics Joined With In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

(2012) A Rostami-Hodjegan   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically Based Pharmacokinetic Modeling at the Extremes of Age

(2012) C Johnston et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

(2012) R Leong et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Drug Disposition in Pathophysiological Conditions

(2012) Adarsh Gandhi et al.   CURRENT DRUG METABOLISM

Pediatric Versus Adult Drug Trials for Conditions With High Pediatric Disease Burden

(2012) F. T. Bourgeois et al.   PEDIATRICS

Clinically Significant Psychotropic Drug-Drug Interactions in the Primary Care Setting

(2012) Brett A. English et al.   Current Psychiatry Reports

Clinically Relevant Genetic Variations in Drug Metabolizing Enzymes

(2011) Navin Pinto et al.   CURRENT DRUG METABOLISM

Pharmacogenetics, Pharmacogenomics, and Individualized Medicine

(2011) Q. Ma et al.   PHARMACOLOGICAL REVIEWS

Factors and Mechanisms for Pharmacokinetic Differences between Pediatric Population and Adults

(2011) Eva Fernandez et al.   Pharmaceutics

Deconstructing the Drug Development Process: The New Face of Innovation

(2010) K I Kaitin   CLINICAL PHARMACOLOGY & THERAPEUTICS

Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs

(2010) J A DiMasi et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Membrane transporters in drug development

(2010)   NATURE REVIEWS DRUG DISCOVERY

Predicting Drug–Drug Interactions: An FDA Perspective

(2009) Lei Zhang et al.   AAPS Journal

Insights into the Substrate Specificity, Inhibitors, Regulation, and Polymorphisms and the Clinical Impact of Human Cytochrome P450 1A2

(2009) Shu-Feng Zhou et al.   AAPS Journal

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

(2009) Efthymios Manolis et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

What is the right dose for children?

(2009) Massimo Cella et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Mass spectrometry-based absolute quantification of microsomal cytochrome P450 2D6 in human liver

(2009) Elmar Langenfeld et al.   PROTEOMICS

Pediatric liver transplantation

(2009) Marco Spada et al.   WORLD JOURNAL OF GASTROENTEROLOGY

The Nuclear Factor NF- B Pathway in Inflammation

(2009) T. Lawrence   Cold Spring Harbor Perspectives in Biology

Overview of Therapeutic Drug Monitoring

(2009) Ju-Seop Kang et al.   KOREAN JOURNAL OF INTERNAL MEDICINE

Developmental Changes in Human Liver CYP2D6 Expression

(2008) J. C. Stevens et al.   DRUG METABOLISM AND DISPOSITION

Decreased Expression of Cytochromes P450 1A2, 2E1, and 3A4 and Drug Transporters Na+-Taurocholate-Cotransporting Polypeptide, Organic Cation Transporter 1, and Organic Anion-Transporting Peptide-C Correlates with the Progression of Liver Fibrosis in Chronic Hepatitis C Patients

(2008) K. Nakai et al.   DRUG METABOLISM AND DISPOSITION

The ontogeny of drug metabolism enzymes and implications for adverse drug events

(2008) Ronald N. Hines   PHARMACOLOGY & THERAPEUTICS