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1. Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial

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

3. 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

4. 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

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

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

8. 192-OR: Glycemic Control with Once-Weekly Basal Insulin Fc (BIF) in Persons with Type 2 Diabetes Mellitus (T2DM) Using Continuous Glucose Monitoring (CGM) in a Phase 2 Study

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

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

11. Simulation-Based Evaluation of Dose-Titration Algorithms for Rapid-Acting Insulin in Subjects with Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antihyperglycemic Medications

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

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

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

15. A Comprehensive Review of Novel Drug-Disease Models in Diabetes Drug Development

16. 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

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

18. 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

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

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

21. A new probabilistic rule for drug–dug interaction prediction

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

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

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

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

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

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

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

29. Influence of polymorphic N-acetyltransferase phenotype on the inhibition and induction of acetaminophen bioactivation with long-term isoniazid*

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

31. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics

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

33. Drug Delivery Trends in Clinical Trials and Translational Medicine: Growth in Biologic Molecule Development and Impact on Rheumatoid Arthritis, Crohn’s Disease, and Colitis

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

35. 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

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

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

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

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

40. [Untitled]

41. Drug delivery trends in clinical trials and translational medicine

42. Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation

43. Ho RJ, Chien JY. 2012. 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 Pharm Sci 101:2668–2674

46. Projection of doses for QT-prolongation studies based on modeling of the worst-case inhibition of CYP3A

47. A bivariate confidence interval approach to calculate drug interaction and bioequivalence study power

48. The Effects of LY2405319, an FGF21 Analog, in Obese Human Subjects with Type 2 Diabetes

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