J. Chien

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Pharmacokinetics/pharmacodynamics and the stages of drug development: Role of modeling and simulation

Vikram Sinha, Jenny Y. Chien, J. Chien, 2005, The AAPS Journal.

A 5‐week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long‐acting glucagon‐like peptide‐1 analogue, in patients with type 2 diabetes

T. Hardy, F. Tibaldi, J. Chien, 2011, Diabetes, obesity & metabolism.

An Adaptive, Dose-Finding, Seamless Phase 2/3 Study of a Long-Acting Glucagon-like Peptide-1 Analog (Dulaglutide): Trial Design and Baseline Characteristics

J. Chien, S. Berry, Z. Skrivanek, 2012, Journal of diabetes science and technology.

Development and Qualification of a Drug‐Disease Modeling Platform to Characterize Clinically Relevant Endpoints in Type 2 Diabetes Trials

J. Chien, F. K. Hurtado, S. Schmidt, 2018, Clinical pharmacology and therapeutics.

Optimization of Drug-Drug Interaction Study Design: Comparison of Minimal Physiologically Based Pharmacokinetic Models on Prediction of CYP3A Inhibition by Ketoconazole

J. Chien, J. Mao, S. Hall, 2013, Drug Metabolism and Disposition.

Dose dependent inhibition of midazolam elimination by ketoconazole: Effect of CYP3A5 genotype

J. Chien, S. Hall, M. Hamman, 2005 .

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.

Rhys D O Jones, Vikash K. Sinha, V. Fischer, 2011, Journal of pharmaceutical sciences.

CYP2E1 activity before and after weight loss in morbidly obese subjects with nonalcoholic fatty liver disease

E. P. Dellinger, K. Kowdley, E. Kharasch, 2003, Hepatology.

LY2189265, a long‐acting glucagon‐like peptide‐1 analogue, showed a dose‐dependent effect on insulin secretion in healthy subjects

F. Tibaldi, J. Chien, P. Barrington, 2011, Diabetes, obesity & metabolism.

Trends in translational medicine and drug targeting and delivery: new insights on an old concept-targeted drug delivery with antibody-drug conjugates for cancers.

J. Chien, R. Ho, 2014, Journal of pharmaceutical sciences.

Inhaled micronized crystalline human insulin using a dry powder inhaler: dose‐response and time‐action profiles 1

L. Heinemann, K. Rave, L. Nosek, 2004, Diabetic medicine : a journal of the British Diabetic Association.

Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials

J. Chien, M. Heathman, A. de la Peña, 2016, Clinical Pharmacokinetics.

Saturable Tissue Binding and Imirestat Pharmacokinetics in Rats

J. Chien, C. Banfield, J. Slattery, 1992, Pharmaceutical Research.

First‐in‐Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID‐19

Karen L. Price, M. Mulligan, N. Rouphael, 2021, Clinical pharmacology and therapeutics.

Optimization of trial duration to predict long‐term HbA1c change with therapy: A pharmacometrics simulation‐based evaluation

J. Chien, M. Kjellsson, P. Garhyan, 2022, CPT: pharmacometrics & systems pharmacology.

Drug delivery trends in clinical trials and translational medicine: Updated analysis of ClinicalTrials.gov database.

J. Chien, R. Ho, 2009, Journal of pharmaceutical sciences.

Influence of polymorphic N‐acetyltransferase phenotype on the inhibition and induction of acetaminophen bioactivation with long‐term isoniazid

J. Chien, R. Peter, S. Nelson, 1997, Clinical pharmacology and therapeutics.

Estimating Dose Equivalence for New Routes of Drug Administration

J. Chien, D. Muchmore, G. Weerakkody, 2004, Journal of biopharmaceutical statistics.

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

Malcolm Rowland, Thierry Lavé, Rhys D O Jones, 2011, Journal of pharmaceutical sciences.

Age-dependent tetrahydrothiophenium ion formation in young children and adults receiving high-dose busulfan.

J. Chien, J. Gibbs, J. Slattery, 1997, Cancer research.

Predictions of the In Vivo Clearance of Drugs from Rate of Loss Using Human Liver Microsomes for Phase I and Phase II Biotransformations

B. Ring, S. Wrighton, M. Mohutsky, 2006, Pharmaceutical Research.

Ethanol and production of the hepatotoxic metabolite of acetaminophen in healthy adults

P. Watkins, J. Chien, S. Nelson, 2000, Clinical pharmacology and therapeutics.

Pharmacokinetic consequences of induction of CYP2E1 by ligand stabilization.

J T Slattery, J. Chien, K. Thummel, 1997, Drug metabolism and disposition: the biological fate of chemicals.

The effects of LY2405319, an FGF21 analog, in obese human subjects with type 2 diabetes.

H. Fu, D. Moller, J. Chien, 2013, Cell metabolism.

Application of Adaptive Design Methodology in Development of a Long-Acting Glucagon-like Peptide-1 Analog (Dulaglutide): Statistical Design and Simulations

Brenda Gaydos, Zachary Skrivanek, Mary Jane Geiger, 2012, Journal of diabetes science and technology.

A Comprehensive Review of Novel Drug–Disease Models in Diabetes Drug Development

Mirjam N Trame, J. Chien, S. Schmidt, 2016, Clinical Pharmacokinetics.

Dose‐finding results in an adaptive, seamless, randomized trial of once‐weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD‐5)

J. Chien, M. Heathman, S. Berry, 2014, Diabetes, obesity & metabolism.

Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study.

J. Frias, J. Chien, W. Landschulz, 2023, The lancet. Diabetes & endocrinology.

Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once‐weekly dosing for the treatment of patients with diabetes

J. M. Beals, T. Heise, J. Chien, 2022, Diabetes, obesity & metabolism.

STOCHASTIC PREDICTION OF CYP3A-MEDIATED INHIBITION OF MIDAZOLAM CLEARANCE BY KETOCONAZOLE

Jenny Y Chien, S. Wrighton, J. Chien, 2006, Drug Metabolism and Disposition.

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: goals, properties of the PhRMA dataset, and comparison with literature datasets.

Thierry Lavé, Rhys D O Jones, James W T Yates, 2011, Journal of pharmaceutical sciences.

The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents

J. Chien, V. Sinha, 2011 .

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.

Malcolm Rowland, Thierry Lavé, Rhys D O Jones, 2011, 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.

Malcolm Rowland, Thierry Lavé, Volker Fischer, 2011, Journal of pharmaceutical sciences.

Development and Verification of a Body Weight–Directed Disease Trial Model for Glucose Homeostasis

J. Chien, S. Schmidt, P. Garhyan, 2020, Journal of clinical pharmacology.

Drug delivery trends in clinical trials and translational medicine: evaluation of pharmacokinetic properties in special populations.

J. Chien, R. Ho, 2011, Journal of pharmaceutical sciences.

Evaluation of Various Static In Vitro–In Vivo Extrapolation Models for Risk Assessment of the CYP3A Inhibition Potential of an Investigational Drug

J Snoeys, S D Hall, L Zhang, 2014, Clinical pharmacology and therapeutics.

A new probabilistic rule for drug–dug interaction prediction

Lang Li, Menggang Yu, J. Chien, 2009, Journal of Pharmacokinetics and Pharmacodynamics.

DMD050732 1329..1338

J. Chien, J. Mao, S. Hall, 2013 .

A Quantitative Modeling and Simulation Framework to Support Candidate and Dose Selection of Anti‐SARS‐CoV‐2 Monoclonal Antibodies to Advance Bamlanivimab Into a First‐in‐Human Clinical Trial

Timothy D. Knab, J. Chien, M. Riggs, 2021, Clinical pharmacology and therapeutics.

Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID‐19 Infection

J. Chien, E. Chigutsa, A. Long, 2021, Clinical pharmacology and therapeutics.

Once Weekly Basal Insulin Fc (BIF) is Safe and Efficacious in Patients with Type 2 Diabetes Mellitus (T2DM) Previously Treated With Basal Insulin

J. Frias, J. Chien, W. Landschulz, 2021, Journal of the Endocrine Society.

Basal Insulin Fc (BIF), A Novel Insulin Suited For Once Weekly Dosing For The Treatment of Patients With Diabetes Mellitus

J. M. Beals, T. Heise, J. Chien, 2021 .

Drug delivery trends in clinical trials and translational medicine.

J. Chien, R. Ho, 2008, Journal of pharmaceutical sciences.

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial

J. Bue-Valleskey, J. Frias, J. Chien, 2023, Diabetes care.

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

J. Bue-Valleskey, J. Chien, W. Landschulz, 2023, Diabetes care.

Drug delivery trends in clinical trials and translational medicine: growth in biologic molecule development and impact on rheumatoid arthritis, Crohn's disease, and colitis.

J. Chien, R. Ho, 2012, Journal of pharmaceutical sciences.

Desipramine, substrate for CYP2D6 activity: population pharmacokinetic model and design elements of drug-drug interaction trials.

Kimberley Jackson, Ivelina Gueorguieva, Jenny Y Chien, 2010, British journal of clinical pharmacology.

The effects of LY2405319, an FGF21 analog, in obese human subjects with type 2 diabetes.

H. Fu, D. Moller, J. Chien, 2013, Cell metabolism.

Physiological approaches to the prediction of drug-drug interactions in study populations.

S. Wrighton, M. Mohutsky, J. Chien, 2003, Current drug metabolism.

Drug–Disease Model-Based Development of Therapeutic Agents for Treatment of Diabetes

M. Danhof, B. Topp, J. Chien, 2014 .

PK/PD modeling links accelerated resolution of COVID‐19‐related clinical symptoms to SARS‐CoV‐2 viral load reduction in patients following treatment with Bamlanivimab alone or Bamlanivimab and Etesevimab together

J. Chien, C. Ernest, E. Chigutsa, 2022, CPT: pharmacometrics & systems pharmacology.