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Replicable Assays: Not the Impossible Dream

PerkinElmer

In drug development, assays are test systems that gauge the effects of chemical compounds on certain cellular, molecular, or biochemical processes. They are a vital step in modern pharma research that pushes drugs to market faster. These are just three of the steps to take toward reliable and replicable assay development.

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Choosing the Best Bioanalytical Platform for Your Program

Alta Sciences

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Image blog-thumbnail-bioanalytical-platform-selection_0.png

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.