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Replicable Assays: Not the Impossible Dream

PerkinElmer

These are just three of the steps to take toward reliable and replicable assay development. The post Replicable Assays: Not the Impossible Dream first appeared on PerkinElmer Blog. It’s also important to consider if plates will be compatible with your lab’s current screening instrumentation.

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Choosing the Best Bioanalytical Platform for Your Program

Alta Sciences

Our solutions include standalone services or integrated programs, providing assay development and top-quality data for toxicokinetic (TK) , pharmacokinetic (PK), and pharmacodynamic (PD) determinations to support your nonclinical and clinical studies. 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

There was a lot of information on CMC regulatory requirements and pitfalls for cellular therapies and tissue engineered products discussed during the OTAT town hall that are not included in this blog.

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

The Premier Consulting Blog

Development of the manufacturing process description The development of the MPD is an iterative process. 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.