As more companies try to ensure that their validation activities are compliant and cost-effective, it has become increasingly important for quality professionals and validation technicians to manage ...
As part of the United States Food and Drug Administration's (FDA's) Critical Path Initiative to medical product development (http://www.fda.gov/oc/initiatives ...
Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.
Objectives This study describes the prototype testing and clinical validation of the Fit-Frailty App, a fully guided, interactive mobile health (mHealth) app to assess frailty and sarcopenia. This ...
Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel. Q. We are planning to market a new drug (film coated ...
Background Although chest X-rays (CXRs) are widely used, diagnosing mitral stenosis (MS) based solely on CXR findings remains ...
Biodesix, Inc. announced a new study published in CHEST Pulmonary Journal reaffirming the effectiveness of its Nodify CDT® blood-based lung nodule test, which assesses seven autoantibodies linked to ...
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