Sep 17, 2021 13:16
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PHARMACY - LIFE SCIENCES
Native in: Russian
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Medical: Pharmaceuticals
Table 5.1-4. Overview of PF-07104091 Safety Pharmacology Program
Study
Ex Vivo Studies
Rat Isolated
Aorta Study Isolated Guinea
Concentration or Dose
169 pM-30 *pM*
0.01-30 pM
In the ex vivo cardiovascular studies, the most potent PF-07104091 activity had an IC50 = 10 μM which is 20x the projected unbound Cmax at the clinical starting dose of 75 mg BID. In the 1-month pivotal GLP dog toxicity study, no cardiovascular effects were observed up to 30 mg/kg/day, giving a safety margin of 5.4x based on the total Cmax (see Table 5.1-2).
Study
Ex Vivo Studies
Rat Isolated
Aorta Study Isolated Guinea
Concentration or Dose
169 pM-30 *pM*
0.01-30 pM
In the ex vivo cardiovascular studies, the most potent PF-07104091 activity had an IC50 = 10 μM which is 20x the projected unbound Cmax at the clinical starting dose of 75 mg BID. In the 1-month pivotal GLP dog toxicity study, no cardiovascular effects were observed up to 30 mg/kg/day, giving a safety margin of 5.4x based on the total Cmax (see Table 5.1-2).
Proposed translations
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| 3 +1 | пМ |
Evgeni Kushch
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Proposed translations
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6 mins
Evgeni Kushch
Ukraine
Ukraine
Native in Russian
Specializes in field
Ukraine
MD with 12+ years in medical translation
Native in: Russian (Variant: Standard-Russia) 
, Ukrainian (Variant: Standard-Ukraine)
Works in: English to Russian, English to Ukrainian, Russian to English, and 3 more.
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