AAPS IVRDT Focus Group Method Development Talking Points

1
AAPS IVRDT Focus Group Method Development Talking
Points

• Vivian A. Gray
• April 29, 2005

2
Compendial Initiatives

• New PREVIEWED General Informational Chapter -
  Due in PF Sept. -Oct. 2005
• lt1092gt The Dissolution Procedure Development and
  Validation
• Performance tests for all dosage forms

3
Method Development for Novel Dosage Forms

• Challenging analytical considerations
• Sample Introduction
• Sample mixing/floating particles
• Sampling technique
• Poorly Soluble
• Sink

4
Method Development of Novel Dosage Forms

• Poorly soluble
• Handling of surfactants
• Cleaning
• Deaeration
• Vibration
• IVIV relationship
• Is a dissolution test needed? YES

5
Static Tubes

• www.aapspharmscitech.org. Volume 1 issue 1,
  article 4. The title is "A Novel in vitro release
  technique for peptide-containing biodegradable
  Microspheres" by Janusz Kostanski and Patrick
  DeLuca.
• Jacketed tube on a magnetic stirrer with ports
  for sampling

6
(No Transcript)
7
(No Transcript)
8
(No Transcript)
9
(No Transcript)
10
(No Transcript)
11
(No Transcript)
12
(No Transcript)
13
(No Transcript)
14
(No Transcript)
15
(No Transcript)
16
(No Transcript)
17
(No Transcript)
18
(No Transcript)
19
(No Transcript)
20
(No Transcript)
21
(No Transcript)
22
(No Transcript)
23
(No Transcript)
24
(No Transcript)
25
(No Transcript)
26
New Frontiers

• FDAs initiative on Calibration, Specs and in
  line testing
• FDA Pharmaceutics Advisory meeting on May 3
• QBD and PAT