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Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories

PPD

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The protocol and statistical analysis plan should clearly specify the plans for specimen collection, sample analysis and related clinical outcomes depending on the biomarker assay development and validation strategy. The pharmaceutical trade association EFPIA has released its comments on the concept paper , however.