Maswali yanayounganishwa na mwongozo · Kati Kiwango
AI katika Maswali ya Pharma
Hutathmini muktadha wa matumizi, uthibitishaji, ubora wa data, ushahidi wa uchunguzi, tathmini ya mzunguko wa maisha na ufuatiliaji wa maamuzi.
Swali 1 ya 8
A model ranks compounds for laboratory testing. What must be specified before interpreting its performance?
Hakiki kila swali8 maswali
Majibu na maelezo huonekana unapojibu maswali.
- A model ranks compounds for laboratory testing. What must be specified before interpreting its performance?
- Only the model family name
- The number of dashboard charts
- The final commercial price
- Intended use, population, endpoint, and decision boundary
- Why is retrospective performance insufficient by itself for a clinical or regulatory claim?
- Historical data are never useful
- The validation may not match prospective context, population, or information timing
- Retrospective models cannot be evaluated
- A large test set guarantees approval
- A biomarker model is evaluated on records from the same sites used for training. What transfer question remains?
- Whether it generalizes to a new study site or data conditions
- Whether the training loss reached zero
- Whether it has a polished interface
- Whether the feature names are alphabetized
- Why inspect batch effects and missing measurements?
- They only affect storage costs
- Missing data always improve generalization
- They can distort model inputs or create apparent patterns unrelated to the target
- Batch labels are equivalent to outcomes
- What does the guide say FDA/EMA AI principles do?
- Approve every model that follows a checklist
- Offer a framework for evidence and accountability, not blanket model approval
- Replace context-of-use validation
- Guarantee a regulatory submission succeeds
- A model is used to prioritize exploratory lab work. How should that result be described?
- As proof of clinical effectiveness
- As a validated patient outcome
- As a regulatory decision by itself
- As an exploratory hypothesis unless evidence supports a stronger claim
- When assay data or model versions change, what should the team do?
- Assume the prior validation remains unchanged
- Delete the previous protocol
- Use the documented reassessment trigger and evaluate the new setup
- Keep the old version in reporting only
- Why retain protocols, model outputs, and review decisions?
- They support traceability and later review of the evidence and decisions
- They guarantee the model is unbiased
- They eliminate monitoring
- They are substitutes for data provenance