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

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10 x 10 test
unit 1 2 10 mean S.D.
1 repeat-
2 ability

10
mean varia bility gt
S.D.
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 gt 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

• gt 2 billion prescriptions/year of FDA regulated
  drugs
• same non-prescription (may be post control)
  drugs
• gt 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

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Clinical Trials Considerations

• FDA
• IRB
• Phase 1, 20 100, adverse effects, dose size
• Phase 2, several 100, short term safety,
  effectiveness
• Phase 3, 100s 1000s, safety, dose,
  effectiveness
• 1/5000
• FDA New Drug Approval
• Phase 4, long term followup studies