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Premarket Testing and Validation

Learn about the importance of premarket testing and validation in ensuring the quality, reliability, and safety of products. Explore various testing methods and strategies used in different industries, such as software testing and drug development.

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Premarket Testing and Validation

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  1. Premarket Testing and Validation "The greatest lesson in life is to know that even fools are right sometimes" Sir Winston Churchill

  2. Standard Tests • Cycle testing [on/off, etc.] • Typical use testing [Elec. & Mech. Test, typical, aim for MTBF values] • 10 x 10 testing [10 samples, 10 tests, goal is repeatability & variability value]

  3. 10 x 10 test

  4. Software Testing • Designers should specify test information sheets to check validity • Prioritized by safety, reliability, performance, other… • Testing by components, then final

  5. Validation and Verification Test Method Commonality • Check hardware & software • Implement a common test set • Use data generator tools (canned batch mode data files, etc.)

  6. Verification & Validation Reporting • Time/# of cycles run • Tasks performed • Summary of task results • Summary of errors & resolution • Description & location • Impact • Assessment of the software reliability

  7. Essentials of software testing: • Quality of tests => success • Use early life-cycle testing • Test now, not later • Require one to be responsible • Use trained, disciplined personnel for testing • Test creatively, use teamwork

  8. Drug Development • > 2 billion prescriptions/year of FDA regulated drugs • ~ same non-prescription (may be post control) drugs • > $400,000,000 developmental costs per new drug • Test new compounds • Computer models, test • Test compounds from nature

  9. Drug testing • 2+ animal models, based upon parallels to human & sensitivity to disease studied • Rodents • Rabbits • Dogs, cats • Primates • …

  10. Clinical Trials: Considerations • FDA • IRB • Phase 1, 20 – 100, adverse effects, dose size • Phase 2, several 100, short term safety, effectiveness • Phase 3, 100’s – 1000s, safety, dose, effectiveness • ~ 1/5000 • FDA – New Drug Approval • Phase 4, long term followup studies

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