Premarket Testing and Validation

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Transcript Premarket Testing and Validation

Premarket Testing and
Validation
"The greatest lesson in life is to know
that even fools are right sometimes"
Sir Winston Churchill
Standard Tests
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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]
10 x 10 test
unit
1
2
…
10
mean
1
repeat
-
2
ability
…
10
mean
S.D.
varia bility =>
S.D.
Software Testing
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Designers should specify test
information sheets to check validity
Prioritized by safety, reliability,
performance, other…
Testing by components, then final
Validation and Verification Test Method
Commonality
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Check hardware & software
Implement a common test set
Use data generator tools (canned
batch mode data files, etc.)
Verification & Validation Reporting
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Time/# of cycles run
Tasks performed
Summary of task results
Summary of errors & resolution
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Description & location
Impact
Assessment of the software
reliability
Essentials of software testing:
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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
Drug Development
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> 2 billion prescriptions/year of FDA
regulated drugs
~ same non-prescription (may be
post control) drugs
> $400,000,000 developmental
costs per new drug
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Test new compounds
Computer models, test
Test compounds from nature
Drug testing
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2+ animal models, based upon
parallels to human & sensitivity to
disease studied
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Rodents
Rabbits
Dogs, cats
Primates
…
Clinical Trials: Considerations
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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