Combination of assay results documents
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Combination of independent assay results
.... Name
.... Identification
.... Date
.... Documentation
........ Assay purpose
........ User instruction
........ Alternatives
............ Substance name
............ Substance reference
........ Substance identification
........ Substance batch/lot number
........ Substance sub-batch/sub-lot number
........ Substance variant
........ Substance class
........ Substance description
........ Operator
............ Alternatives
................ Operator name
................ Operator reference
.................... Config
........................ Update mode
............ Role
........ Equipment
............ Alternatives
................ Equipment name
................ Equipment reference
.................... Config
........................ Update mode
........ User variable
............ Key
............ Value
........ Groups
............ Group
................ Name
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
.... Setup
........ Potency data
............ Observation source
............ Row order
............ Document reference
................ Name
................ Column key
................ Edit mode
................ Update mode
................ Document type
................ Template key
................ Folder key
................ Allow subfolder
................ Generator key
................ Document mode
................ Document property filter
................ Section property filter
............ Column: Section
................ Name
................ Column key
................ Property filter
.................... Property key
.................... Term
............ Group
................ Name
............ Column: Exclude from analysis
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
............ Relative potency
................ Name
............ Relative potency lower confidence limit
................ Name
............ Relative potency upper confidence limit
................ Name
............ Absolute potency
................ Name
............ Absolute potency unit
................ Name
............ Absolute potency lower confidence limit
................ Name
............ Absolute potency upper confidence limit
................ Name
............ Column: Model
................ Name
............ Column: Degrees of freedom
................ Name
............ Column: Potency confidence level
................ Name
............ Column: Assay test state
................ Name
.... Analysis
........ Alternatives
............ Combination type
............ Combination type based on homogeneity test
................ Significance level (homogeneity test)
........ Compendial guidance
........ Potency type
........ Logarithm type
........ Suitability tests
............ Alternatives
................ Test: Coefficient of variation (%)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Geometric coefficient of variation (%)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Log potency range (L-value)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Mean coefficient of variation (%)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Number of invalid assays
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
................ Test: Number of valid assays
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
................ Test: Potency spread (%)
.................... Upper margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Sum of weights
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Combined log potency confidence interval width (L-term)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Combined potency confidence interval
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Combined potency confidence interval (%)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Combined potency confidence interval range (%)
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Combined potency value
.................... Upper margin
.................... Lower margin
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Homogeneity
.................... Alternatives
........................ Confidence level (%)
........................ p
.................... Severity level of the test
.................... Scope of the test
.................... Rounding
................ Test: Signature status
.................... Number of signatures
.................... Meaning
.................... Severity level of the test
.................... Scope of the test
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author