28 results on '"Lionberger, Robert"'
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2. Bioavailability and Bioequivalence
3. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products
4. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
5. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
6. Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing
7. Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
8. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
9. CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products
10. Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products
11. A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution
12. Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
13. A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution
14. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration
15. Effect of Device Design on the In Vitro Performance and Comparability for Capsule-Based Dry Powder Inhalers
16. Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers
17. Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations
18. Using Partial Area for Evaluation of Bioavailability and Bioequivalence
19. Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products
20. Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development
21. Quality by Design: Concepts for ANDAs
22. FDA Critical Path Initiatives: Opportunities for Generic Drug Development
23. Bioequivalence Approaches for Highly Variable Drugs and Drug Products
24. Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle
25. Spreadability Measurements to Assess Structural Equivalence (Q3) of Topical Formulations—A Technical Note
26. Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
27. Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
28. Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations
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