Premarket Testing and Validation

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