Introduction
Materials and methods
Study Design
Test Animals
Reference Standards for the FSH and LH assays
Gonadotropin Assays
Bravelle® and Menopur® single solutions
Analyte (Mixture of Bravelle® and Menopur®)
150:75 IU; FSH: LH
300:75 IU; FSH: LH
300:225 IU; FSH: LH
Control Solution
FSH assay
LH assay
Determination of FSH and LH bioactivity: potency calculations
Statistical analysis
Results
FSH Bioassay
Hormone (FSH:LH)a | Total no. rats | Ovarian weights (mean ± SEM)b* | ||
---|---|---|---|---|
Lowc dose | Middled dose | Highe dose | ||
Reference Standard | 48 | 93.55 ± 4.17 | 151.37 ± 4.00 | 193.01 ± 5.02 |
Bravelle® (75:0) | 48 | 92.31 ± 3.02 | 149.60 ± 3.29 | 201.37 ± 4.56 |
Menopur® (75:75) | 48 | 92.19 ± 3.45 | 151.51 ± 2.62 | 194.92 ± 4.03 |
Bravelle® + Menopur® | ||||
(150:75) | 48 | 97.29 ± 2.80 | 148.82 ± 3.65 | 199.59 ± 4.30 |
(300:75) | 48 | 92.38 ± 3.37 | 157.08 ± 3.82 | 192.62 ± 5.50 |
(300:225) | 48 | 95.75 ± 2.94 | 149.50 ± 6.11 | 195.39 ± 6.13 |
Hormone (FSH:LH)a | Theoretical bioactivity IU/mL (%) | Actual bioactivity IU/mL (% claim) | L-valueb |
---|---|---|---|
Bravelle® (75:0) | 75 (100%) | 76.58 (102.1%) | 0.072 |
Menopur® (75:75) | 75 (100%) | 76.0 (101.3%) | 0.072 |
Bravelle® + Menopur® | |||
(150:75) | 150 (100%) | 156.86 (104.6%) | 0.072 |
(300:75) | 300 (100%) | 308.69 (102.9%) | 0.072 |
(300:225) | 300 (100%) | 306.58 (102.2%) | 0.072 |
LH Bioassay
Hormone (FSH:LH)a | Total no. rats | Seminal Vesicle weights (mean ± SEM)b* | ||
---|---|---|---|---|
Lowc dose | Middled dose | Highe dose | ||
Reference Standard | 48 | 35.82 ± 1.64 | 68.88 ± 2.40 | 96.39 ± 2.95 |
Menopur® (75:75) | 48 | 36.49 ± 1.54 | 72.55 ± 1.61 | 95.69 ± 2.87 |
Bravelle®+ Menopur® | ||||
(150:75) | 48 | 36.47 ± 1.23 | 73.94 ± 2.42 | 96.62 ± 1.70 |
(300:75) | 48 | 37.80 ± 1.25 | 74.57 ± 1.57 | 94.49 ± 2.09 |
(300:225) | 48 | 36.28 ± 1.50 | 74.78 ± 1.78 | 95.73 ± 2.01 |
Hormone (FSH:LH)a | Theoretical bioactivity IU/mL (%) | Actual bioactivity IU/mL (% claim) | L-valueb |
---|---|---|---|
Menopur® (75:75) | 75 (100%) | 77.50 (103.3%) | 0.061 |
Bravelle® + Menopur® | |||
(150:75) | 75 (100%) | 78.38 (104.5%) | 0.061 |
(300:75) | 75 (100%) | 78.63 (104.8%) | 0.061 |
(300:225) | 225 (100%) | 233.48 (103.8%) | 0.061 |