920 results on '"Shah, Vinod P."'
Search Results
2. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine
3. In vitro release test (IVRT): Principles and applications
4. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine
5. Regulatory Framework for Biosimilars
6. In Vitro Release from Semisolid Dosage Forms
7. Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium
8. Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects
9. Transdermal Drug Delivery Systems : Regulatory Considerations: NDA and ANDA Requirements
10. In Vitro Product Quality Tests and Product Performance Tests for Topical and Transdermal Drug Products
11. Challenges in Evaluating Bioequivalence of Topical Dermatological Drug Products
12. Importance of In Vitro Drug Release
13. In Vivo and In Vitro Correlations
14. Challenges with Successful Commercialization of Biosimilars: This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics
15. Commonality between BCS and TCS
16. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
17. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”
18. Report on the AAPS Immunogenicity Guidance Forum
19. A science based approach to topical drug classification system (TCS)
20. Biowaiver monograph for immediate-release dosage Forms: Levamisole hydrochloride
21. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride
22. Regulatory Framework for Biosimilars
23. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride
24. Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride
25. Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Codeine Phosphate
26. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate
27. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam
28. Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
29. Bioavailability and Bioequivalence of Transdermal Drug Delivery Systems : Regulatory Considerations
30. Bioequivalence of Topical Dermatological Products
31. Assessment of Topical Corticosteroid Bioavailability In Vivo and In Vitro
32. Practical Considerations in Developing a Quality Control (In Vitro Release) Procedure for Topical Drug Products
33. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development
34. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks
35. Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years
36. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
37. in Vitro Dissolution Profile Comparison and IVIVR : Carbamazepine Case
38. Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products
39. Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop summary report
40. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS
41. Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report
42. Progressively Reducing Regulatory Burden
43. Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm
44. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
45. Different Pharmaceutical Products Need Similar Terminology
46. How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider
47. Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report
48. Regulatory Science in Drug Development
49. The Relations Between Q3 Measurements, In vitro Release and TCS
50. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.