Skip to main content

Table 1 Actual dose and summary of calculation of active content as a percentage of target (n = 28, pharmacokinetic population)

From: Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

Parameter

Formulation

 

A

B

C

Actual dose (geometric mean [CV%] mg)

3.695 (3.26)

3.591 (2.92)

3.662 (3.95)

Active content (AC), mg

6.0

7.7

8.2

Container volume (V), mL

1.03

1.0

-

Concentration (AC/V), mg/mL

5.825

7.7

5.43

Target concentration (T), mg/mL

5.83

8.0

-

Percentage of target concentration

A and B: 100 × [AC/V]/T

C: 100 × [AC/T]

99.92

96.25

93.18

  1. CV, coefficient of variation; r-hGH, recombinant human growth hormone.
  2. A = r-hGH liquid multi-dose, 5.83 mg/mL; injection of 0.686 mL.
  3. B = r-hGH liquid multi-dose, 8.0 mg/mL; injection of 0.5 mL.
  4. C = r-hGH freeze-dried 8.8 mg, reconstituted in 1.51 mL; injection of 0.686 mL.