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76 results on '"Lawrence J. Lesko"'

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1. Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate

2. Is Bioequivalence Established Based on the Reference‐Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations

3. Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study

4. Quantitative Systems Pharmacology Model-Based Predictions of Clinical Endpoints to Optimize Warfarin and Rivaroxaban Anti-Thrombosis Therapy

5. Association of Oral Anticoagulants and Verapamil or Diltiazem With Adverse Bleeding Events in Patients With Nonvalvular Atrial Fibrillation and Normal Kidney Function

7. Application of Pharmacometrics and Systems Pharmacology to Current and Emerging Biologics in Inflammatory Bowel Diseases

8. Semi-mechanistic modelling platform to assess cardiac contractility and haemodynamics in preclinical cardiovascular safety profiling of new molecular entities

9. How Informative Are Drug‐Drug Interactions of Gene‐Drug Interactions?

10. Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)

11. Anticoagulants: What is new and what is the standard?

12. Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products

13. Quantitative Systems Pharmacology Model to Predict the Effects of Commonly Used Anticoagulants on the Human Coagulation Network

14. Identifying clinically relevant sources of variability: The clopidogrel challenge

15. Improving drug safety with a systems pharmacology approach

16. Development of a physiology-directed population pharmacokinetic and pharmacodynamic model for characterizing the impact of genetic and demographic factors on clopidogrel response in healthy adults

17. Predicting Drug Interaction Potential With a Physiologically Based Pharmacokinetic Model: A Case Study of Telithromycin, a Time-Dependent CYP3A Inhibitor

18. Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

19. The Creating an Optimal Warfarin Nomogram (CROWN) Study

20. Couma-Gen: implications for future randomized trials of pharmacogenetic-based warfarin therapy

21. Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues

22. Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

23. The Effect of Food on the Relative Bioavailability of Rapidly Dissolving Immediate-Release Solid Oral Products Containing Highly Soluble Drugs

24. Variability in cimetidine absorption and plasma double peaks following oral administration in the fasted state in humans: correlation with antral gastric motility

25. Use of the erythromycin breath test for in vivo assessments of cytochrome P4503A activity and dosage individualization

26. [Untitled]

27. Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations

28. [Untitled]

29. The Impact of Formulation and Process Changes on In Vitro Dissolution and the Bioequivalence of Piroxicam Capsules

30. Identification of Formulation and Manufacturing Variables That Influence In Vitro Dissolution and In Vivo Bioavailability of Propranolol Hydrochloride Tablets

31. [Untitled]

32. [Untitled]

33. Pharmacokinetics of dacarbazine in the regional perfusion of extremities with melanoma

34. Bioavailability measurements of methazolamide in plasma, red blood cells and whole blood: Implications for bioequivalence studies

35. Clopidogrel: a case for indication-specific pharmacogenetics

36. Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation

37. [Untitled]

38. The effects of age on the pharmacokinetics and biotransformation of theophylline in vivo and in vitro in the Mongolian gerbil (Meriones unguiculatus)

39. A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity

40. The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics

41. Effect of St John's wort on the pharmacokinetics of fexofenadine

42. The effect of amiloride on the in vivo effective permeability of amoxicillin in human jejunum: experience from a regional perfusion technique

43. Model-Based Assessment of Dosing Strategies in Children for Monoclonal Antibodies Exhibiting Target-Mediated Drug Disposition

44. Pharmacokinetic-pharmacodynamic modeling of rivastigmine, a cholinesterase inhibitor, in patients with Alzheimer's disease

45. Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues

46. The Value Meal: Effect of Food on Lapatinib Bioavailability

47. Application of Physiologically Based Pharmacokinetic Modeling to Predict Acetaminophen Metabolism and Pharmacokinetics in Children

48. Pharmacologic profile of NPC 168 (naltrexone phenyl oxime), a novel compound with activity at opioid receptors

49. Corrigendum to 'Variability in cimetidine absorption and plasma double peaks following oral administration in the fasted state in humans: correlation with antral gastric motility' [Eur. J. Pharm. Biopharm. 53 (2002) 37–47]

50. Human effective permeability data forrurosemide, hydrochlorthiazide, ketoprofen and naproxen to be used in the proposed biopharmaceutical drug classification system for IR-products

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