Table of contents
3. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
01:22
4. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
01:22
5. Proposed OSD deformulation workflow
03:41
6. Critical material properties for OSD
01:12
7. Possible development timeframe
01:53
8. Complex Generic Products
01:39
9. The FDA sets different equivalence requirements dependant on the RLD product complexity
01:42
10. Malvern PANalytical measurement solutions
01:23
11. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
01:15
12. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
00:25
13. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:18
14. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:18
15. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:30
16. Oral solid dose: deformulation and IVBE
01:41
17. Bioavailability relates to particle size and solid form
02:20
18. Complex product deformulation using MDRS
01:01
19. Complex product deformulation using MDRS
00:59
20. Complex product deformulation using MDRS
00:49
21. Detecting the presence of different API polymorphs
01:06
22. Linking dissolution rate to particle shape measurements
00:30
23. Linking dissolution rate to particle shape measurements
01:10
24. Understanding the manufacturing process used for the active pharmaceutical ingredient
00:16
25. Understanding the manufacturing process used for the active pharmaceutical ingredient
01:00
26. HPMCAS excipient screening using SEC
02:44
27. Hydroxy ethyl cellulose excipient selection
02:02
28. Excipient grade selection
00:56
29. Conclusion: the OSD deformulation workflow
00:55
30. Thank you for your attentionAny questions?
07:57
31. Contact Information
00:39