| 項次 | 料號 | 數量 | 單位 | 需用日 | 小計 |
| | 品名規格 | | | 單價 | |
| 規格 | |
| 10 |
|
1 |
CS |
20261204 |
|
| | Dog DRF Study (Non-GLP) | | |
________________ |
________________ |
| | 臨床觀察
血中濃度(TK)分析報告
生體內血中濃度(TK)分析方法開發及確效(Dog ) - LC-MS/MS
• Test Design: 8 beagle dogs (washout) are divided into 3 dose groups+1
control
group, with 2 animals per group, half male and half female.
• Administration: Intramuscular injection, once a week, for 4 weeks, wit
h a total of
4 administrations. No recovery period is set.
• Test Indicators: Clinical observation, body weight, food consumption;
clinical
pathology (hematology + blood coagulation + biochemistry + urinalysis):
1 test
during the acclimation period, 1 test after the first administration, an
d 1 test at the
end of the administration period.
• Gross anatomy is performed at the end of the administration period. Mo
ribund
animals during the test will be anatomized in time: record the grossly a
bnormal
tissues and preserve them and conduct histopathological examination on t
hese
grossly abnormal tissues. If there are more than 5 grossly abnormal tiss
ues or
target organs, an extra charge of NTD 1,050 per tissue per animal will b
e added.
• TK Blood Sampling: For animals in the administration groups, blood sam
ples are
collected before administration and at multiple time points after admini
stration on
the first and last dosing day, with a total of 8-10 sampling points each
time.
• Estimated total sample size: 120 samples.
• Protocol and Report: Excel protocol and report
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