DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added ...
Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
Blood was collected from a group of healthy volunteers with informed consent in the registered phlebotomy centre of the Paterson Institute for Cancer Research, Manchester, UK. Plasma was immediately ...
Approved by the Royal Society of Chemistry for purposes of continuing professional development. This course will provide you with the requisite scientific knowledge and understanding of analytical ...
Developing and validating appropriate biological assays can spell success or failure for biopharmaceutical products. Whether using live systems or biologically derived reagents, scientists must ...
The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...
Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...
As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...
The result: A lot of if statements! And you have to type them all! Now imagine that the number of validations increases from 10 to 25 because 15 new use cases must be implemented in the next iteration ...
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