78 results on '"Lionberger, Robert"'
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2. Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
3. Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report
4. 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
5. Effect of Omeprazole Administration on the Pharmacokinetics of Oral Extended‐Release Nifedipine in Healthy Subjects
6. Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop
7. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
8. Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades
9. Research and Education Needs for Complex Generics
10. Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance
11. Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users
12. Bioequivalence for Liposomal Drug Products
13. Regulatory Aspects of Microdialysis: A United States Food and Drug Administration Perspective
14. Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective
15. Regulatory Aspects of Dissolution for Low Solubility Drug Products
16. Bioavailability and Bioequivalence
17. Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
18. Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions
19. Microscopic Theories of the Rheology of Stable Colloidal Dispersions
20. Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?
21. Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology
22. Current Scientific Considerations to Verify Physiologically‐Based Pharmacokinetic Models and Their Implications for Locally Acting Products
23. 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
24. Decision Science for Generic Drug Development and Review
25. Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012
26. Generic Drugs: Expanding Possibilities for Clinical Pharmacology
27. Generating Model Integrated Evidence for Generic Drug Development and Assessment
28. Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective
29. Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time
30. Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 2: Fed State
31. Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 1: Fasted State Conditions
32. In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance
33. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach
34. Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
35. Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop
36. In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions
37. Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs
38. Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract
39. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products
40. Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
41. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard
42. Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products
43. Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
44. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
45. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
46. Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing
47. Development of performance matrix for generic product equivalence of acyclovir topical creams
48. Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
49. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
50. Innovative approaches for demonstration of bioequivalence: the US FDA perspective
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