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Pharmaceutical Stability

Doing the Right Thing versus Doing Things the Right Way. Published by American Association of Pharmaceutical Scientists (AAPS)

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.