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QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)

January 1, 2009

Understanding the relationship between the process and CQAs.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1

December 1, 2008

Using multivariate experiments to define acceptable ranges.

Regulation of Biomarker Clinical Laboratory Tests Used in Personalized Medicine

December 1, 2008

A clear oversight framework for biomarker clinical laboratory tests used in personalized medicine is required.

How to Make the Business Case for Quality by Design

December 1, 2008

No time for QbD? How to convince management to make it a priority.

Global QA and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy

November 1, 2008

A centralized quality control strategy may be the best solution.

Biomanufacturing Pendulum Swings Toward Overcapacity

May 1, 2008

The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.

Evaluation of Dendritic Cell Products Generated for Human Therapy and Immune Monitoring

March 1, 2008

Emerging therapies pose challenges for standardizing QC.

Taking a Closer Look

December 1, 2007

Many companies acknowledged that Western regulatory standards are tougher than those in China.

PAREXEL Appoints Three New GMP Consultants for Europe

October 9, 2007

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

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