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Early Drug Development: What if you Outsource your Analytical Services

By ESOutlook | Tuesday, March 20, 2018

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Scientific knowledge, availability of computing resources, and needs of the customers are the three major criteria for choosing a service provider for analytical services in the early stage of drug development. The service provider should have necessary skill-sets, scientific knowledge to offer their analytical services in the early phase of drug development. Both the client and the service provider need to make sure that they are comfortable and compatible to move forward.

Based on the project plan, clients should ensure that the service provider can deliver its service within a required time frame and as well meet all requirements. Proper communication between the service provider and the client is essential to maintain good relationship until the project concludes.

The service provider should have all forms facilities including a vivarium. Once both the parties define the service to be offered, the project should meet regulatory compliance setup by the federal government departments like, the U.S. Department of Agriculture, Food and Drug Administration, and others.

Analytical services sought by the client during the early drug development stage include bio-analytical services and methods to determine drug substance stability. In the preclinical stage, the service provider should develop analytical methods suitable to test the drug substance and to provide early stability data. Method validation need not be focused on in the early phase substance, but the methods should be appropriate during the development phase.

Study of the dosing material is required in bridging the studies and essential for maintaining good laboratory practice as a concluding point of early drug development process.

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