ARTICLES

How ICH Is Changing Drug Development
Regulatory Starting Materials and the Importance of Starting with Big Ideas. Published by American Association of Pharmaceutical Scientists (AAPS)

Drug Risk Probabilities
Balancing clinical and manufacturing investment.

Virtual Quality Assurance
Sponsor responsibilities for virtual pharma.

Managing Phase 2 CMC Risk
Strategies for optimizing early stage investments in CMC.

Translating QbD Guidance into Development Objectives
Practical suggestions for translating FDA initiatives in Quality by Design (QbD) into phase appropriate development goals.

Top Five Reasons for CMC Clinical Holds
How to prevent the five most common CMC errors that can delay your drug development program.

Timing Method Validation
Discussion of factors which influence the timing of analytical method validation.

Practical SOP; Lower Cost of Goods
How streamlined Quality Control procedures can lower the cost of goods by increasing production efficiency.

Know Your Process Limits
Discussion of establishing fail point limits for critical process variables and formulation specifications.

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