304 results on '"Lionberger, Robert"'
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2. Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report
3. Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
4. Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance
5. Research and Education Needs for Complex Generics
6. Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions
7. Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time
8. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach
9. Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs
10. Effect of Omeprazole Administration on the Pharmacokinetics of Oral Extended‐Release Nifedipine in Healthy Subjects
11. Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
12. Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
13. Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products : Summary of workshop
14. Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop
15. Bioequivalence for Liposomal Drug Products
16. Regulatory Aspects of Microdialysis: A United States Food and Drug Administration Perspective
17. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
18. Bioavailability and Bioequivalence
19. Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective
20. In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance
21. Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
22. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products
23. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
24. Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products
25. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
26. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
27. Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing
28. Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades
29. Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
30. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
31. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard
32. CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products
33. Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products
34. A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution
35. Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
36. A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution
37. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration
38. Effect of Device Design on the In Vitro Performance and Comparability for Capsule-Based Dry Powder Inhalers
39. Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers
40. Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations
41. Using Partial Area for Evaluation of Bioavailability and Bioequivalence
42. Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products
43. Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development
44. Development of performance matrix for generic product equivalence of acyclovir topical creams
45. Quality by Design: Concepts for ANDAs
46. Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users
47. FDA Critical Path Initiatives: Opportunities for Generic Drug Development
48. Bioequivalence Approaches for Highly Variable Drugs and Drug Products
49. Bioequivalence for Liposomal Drug Products
50. Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective
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