18-01-2012, 01:22 PM
Strategies for Pharmaceuticals Product Development in Regulated market
Product development strategies.ppt (Size: 957.5 KB / Downloads: 55)
Stage 1: Literature Search
.Literature Research:
USP, BP, Pharm. Eur, PDR, Martindale, Merck, Florey, Vidal
.FDA: Summary Basis of Approval
.On-line computerized search
.FDA CDER: Evaluation of Biostudy parameters, Dissolution methods.
.Patent evaluation: Orange Guide + FDA CDER
Stage 2: Active Sourcing
Sourcing for Active Raw Material:
International Suppliers US, European, Asian,
- Review suppliers catalogues & data critically.
Potential Suppliers List:
Request samples and C of A and Specifications,
Evaluate at least two suppliers fully.
Stage 3: Active Evaluation
Evaluate Potential Actives:
Evaluate at least two to three potential active suppliers
• DMF availability
• Compliance with Pharmacopoeial monograph
• Impurity profile and stability
• Potential Polymorphic forms
• Commitment for physical specifications
• Statement of non-patent infringement