Date d'enregistrement: September 26 2019

Duration: 49 minutes 23 seconds

Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important step in ensuring a product meets its target performance profile. Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are crucial. Presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in API solubility, and may even cause an adverse effect to the patient. Polymorph selection, and conformation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous form of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal.

In this second webinar in the series, we will discuss how XRPD method development and verification can be achieved in line with quality assessment requirements. We will consider how the use of different sample preparation techniques and instrument geometries can impact the outcome of an XRPD experiment. We will then look at the regulatory guidance relating to the assessment of the precision, robustness and ruggedness of the method.

Our goal will be to provide a process for defining an appropriate method that is able to rigorously support product quality control assessments while being flexible enough to be realistically applied throughout the lifetime of a pharmaceutical product.

Table of contents
1. Focus on PharmaSolid Form Analysis: Targeting your methods
03:18
2. Why Solid Form Analysis?
01:10
3. What is Quality by Design?
00:59
4. Applying QbD to drug product development
00:34
5. Applying QbD to analytical method development
00:34
6. Step 1: Identify Analytical Target Profile
00:07
7. Establishing the Quality Target Product Profile
01:02
8. When is solid form considered a CMA?
00:38
9. When is solid form considered a CMA?
00:05
10. Step 2-4: Identify Critical Method Attributes Risk AssessmentMethod Operable Design Region
00:10
11. Identify Critical Method Attributes
00:55
12. Peak position accuracy
01:19
13. Peak position accuracy
03:07
14. Sample Transparency Error
00:21
15. Relative intensities
00:57
16. Relative Intensities
02:34
17. Particle statistics
00:43
18. Particle statistics
02:02
19. Particle statistics
01:13
20. Particle statistics
00:23
21. Preferred Orientation (Texture)
01:21
22. Preferred orientation
01:16
23. Preferred orientation
01:27
24. Preferred orientation
01:08
25. Preferred orientation
01:52
26. Background
01:08
27. Background
01:51
28. Background
00:44
29. Background
00:36
30. Background
00:39
31. Resolution
00:52
32. Resolution
00:59
33. Resolution
00:34
34. Step 5-6: Control StrategyLife Cycle Management
00:12
35. Method Control
01:46
36. Control strategy
01:39
37. Method Control
02:32
38. Summary
00:32
39. Thank you for your attention!
00:13
40. Questions and Thank You!
05:51