Table 2.

Calculation table for prediction of IGF-Iavg SDS and IGF-Iavg concentration (ng/mL) values by time after dose

Calculating IGF-Iavg SDSCalculating IGF-Iavg concentration (ng/mL)
Interval (time after dose)Adjustment to measured IGF-I SDS to approximate IGF-Iavg SDSa90% prediction interval of IGF-I SDS adjustment valueAdjustment to measured IGF-I (ng/mL) to approximate IGF-Iavg (ng/mL)bCoefficient of variation (%) of IGF-I (ng/mL) adjustment value
25-48 hoursIGF-I SDS −0.8±0.5IGF-I (ng/mL) × 0.89.0
49-72 hoursIGF-I SDS −1±0.6IGF-I (ng/mL) × 0.78.3
73-96 hoursIGF-I SDS −0.5±0.4IGF-I (ng/mL) × 0.97.4
97-120 hoursNo adjustmentcN/ANo adjustmentcN/A
121-144 hoursIGF-I SDS +0.7±0.4IGF-I (ng/mL) × 1.310
145-168 hoursIGF-I SDS +1.1±0.6IGF-I (ng/mL) × 1.615
Calculating IGF-Iavg SDSCalculating IGF-Iavg concentration (ng/mL)
Interval (time after dose)Adjustment to measured IGF-I SDS to approximate IGF-Iavg SDSa90% prediction interval of IGF-I SDS adjustment valueAdjustment to measured IGF-I (ng/mL) to approximate IGF-Iavg (ng/mL)bCoefficient of variation (%) of IGF-I (ng/mL) adjustment value
25-48 hoursIGF-I SDS −0.8±0.5IGF-I (ng/mL) × 0.89.0
49-72 hoursIGF-I SDS −1±0.6IGF-I (ng/mL) × 0.78.3
73-96 hoursIGF-I SDS −0.5±0.4IGF-I (ng/mL) × 0.97.4
97-120 hoursNo adjustmentcN/ANo adjustmentcN/A
121-144 hoursIGF-I SDS +0.7±0.4IGF-I (ng/mL) × 1.310
145-168 hoursIGF-I SDS +1.1±0.6IGF-I (ng/mL) × 1.615

Abbreviations: avg, average; CV, coefficient of variation; GHD, growth hormone deficiency; hrs, hours after dose; IGF-I, insulin-like growth factor I; PI, prediction interval; SDS, standard deviation score.

a

Adjustment of IGF-I SDS values should be performed by either adding or subtracting the value provided in the table according to the time point when the sample was obtained.

b

Adjustment of IGF-I (ng/mL) concentration values should be performed through multiplying by the factor provided in the table according to the time point when the sample was obtained.

c

Adjustment for values obtained 97-120 hours after dose is considered not to be required as the predicted adjustments of IGF-I SDS +0.1 (PI 90% +/0.3 SDS) and IGF-I (ng/mL) × 1.1 (6.9 CV%) are not clinically relevant.

Table 2.

Calculation table for prediction of IGF-Iavg SDS and IGF-Iavg concentration (ng/mL) values by time after dose

Calculating IGF-Iavg SDSCalculating IGF-Iavg concentration (ng/mL)
Interval (time after dose)Adjustment to measured IGF-I SDS to approximate IGF-Iavg SDSa90% prediction interval of IGF-I SDS adjustment valueAdjustment to measured IGF-I (ng/mL) to approximate IGF-Iavg (ng/mL)bCoefficient of variation (%) of IGF-I (ng/mL) adjustment value
25-48 hoursIGF-I SDS −0.8±0.5IGF-I (ng/mL) × 0.89.0
49-72 hoursIGF-I SDS −1±0.6IGF-I (ng/mL) × 0.78.3
73-96 hoursIGF-I SDS −0.5±0.4IGF-I (ng/mL) × 0.97.4
97-120 hoursNo adjustmentcN/ANo adjustmentcN/A
121-144 hoursIGF-I SDS +0.7±0.4IGF-I (ng/mL) × 1.310
145-168 hoursIGF-I SDS +1.1±0.6IGF-I (ng/mL) × 1.615
Calculating IGF-Iavg SDSCalculating IGF-Iavg concentration (ng/mL)
Interval (time after dose)Adjustment to measured IGF-I SDS to approximate IGF-Iavg SDSa90% prediction interval of IGF-I SDS adjustment valueAdjustment to measured IGF-I (ng/mL) to approximate IGF-Iavg (ng/mL)bCoefficient of variation (%) of IGF-I (ng/mL) adjustment value
25-48 hoursIGF-I SDS −0.8±0.5IGF-I (ng/mL) × 0.89.0
49-72 hoursIGF-I SDS −1±0.6IGF-I (ng/mL) × 0.78.3
73-96 hoursIGF-I SDS −0.5±0.4IGF-I (ng/mL) × 0.97.4
97-120 hoursNo adjustmentcN/ANo adjustmentcN/A
121-144 hoursIGF-I SDS +0.7±0.4IGF-I (ng/mL) × 1.310
145-168 hoursIGF-I SDS +1.1±0.6IGF-I (ng/mL) × 1.615

Abbreviations: avg, average; CV, coefficient of variation; GHD, growth hormone deficiency; hrs, hours after dose; IGF-I, insulin-like growth factor I; PI, prediction interval; SDS, standard deviation score.

a

Adjustment of IGF-I SDS values should be performed by either adding or subtracting the value provided in the table according to the time point when the sample was obtained.

b

Adjustment of IGF-I (ng/mL) concentration values should be performed through multiplying by the factor provided in the table according to the time point when the sample was obtained.

c

Adjustment for values obtained 97-120 hours after dose is considered not to be required as the predicted adjustments of IGF-I SDS +0.1 (PI 90% +/0.3 SDS) and IGF-I (ng/mL) × 1.1 (6.9 CV%) are not clinically relevant.

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