AstralBio
MA - Boston
BiotechnologyFocus: Machine Learning Antibody Discovery Platform
AstralBio is a life sciences company focused on Machine Learning Antibody Discovery Platform.
Oncology
Funding Stage
PRIVATE
Open Jobs
0
Products & Portfolio (3)
CEFEPIME HYDROCHLORIDE
cefepime hydrochloride
Post-LOE
INJECTION · INJECTABLE
[ See Microbiology ( ].
the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniaeincluding cases associated with concurrent bacteremiaPseudomonas aeruginosa+15 more
2020
30
CEFTRIAXONE
ceftriaxone sodium
Post-LOE
INTRAMUSCULAR, INTRAVENOUS · INJECTABLE
CLINICAL PHARMACOLOGY Average plasma concentrations of ceftriaxone following a single 30-minute intravenous (IV) infusion of a 0.5, 1 or 2 g dose and intramuscular (IM) administration of a single 0.5 (250 mg/mL or 350 mg/mL concentrations) or 1 g dose in healthy subjects are presented in Table 1 . Table 1. Ceftriaxone Plasma Concentrations after Single Dose Administration Average Plasma Concentrations (mcg/mL) Dose/Route 0.5 hour 1 hour 2 hour 4 hour 6 hour 8 hour 12 hour 16 hour 24 hour 0.5 g IV 82 59 48 37 29 23 15 10 5 0.5 g IM 250 mg/mL 22 33 38 35 30 26 16 ND 5 0.5 g IM 350 mg/mL 20 32 38 34 31 24 16 ND 5 1 g IV 151 111 88 67 53 43 28 18 9 1 g IM 40 68 76 68 56 44 29 ND ND 2 g lV 257 192 154 117 89 74 46 31 15 ND = Not determined. * IV doses were infused at a constant rate over 30 minutes. Ceftriaxone was completely absorbed following IM administration with mean maximum plasma concentrations occurring between 2 and 3 hours post-dose. Multiple IV or IM doses ranging from 0.5 to 2 g at 12 to 24 hour intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values. Ceftriaxone concentrations in urine are shown in Table 2 . Table 2. Urinary Concentrations of Ceftriaxone after Single Dose Administration Dose/Route Average Urinary Concentrations (mcg/mL) 0 to 2 hour 2 to 4 hour 4 to 8 hour 8 to 12 hour 12 to 24 hour 24 to 48 hour 0.5 g IV 526 366 142 87 70 15 0.5 g IM 115 425 308 127 96 28 1 g IV 995 855 293 147 132 32 1 g IM 504 628 418 237 ND ND 2 g IV 2692 1976 757 274 198 40 ND = Not determined. Thirty-three percent to 67% of a ceftriaxone dose was excreted in the urine as unchanged drug and the remainder was secreted in the bile and ultimately found in the feces as microbiologically inactive compounds. After a 1 g IV dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after dosing, were 581 mcg/mL in the gallbladder bile, 788 mcg/mL in the common duct bile, 898 mcg/mL in the cystic duct bile, 78.2 mcg/g in the gallbladder wall and 62.1 mcg/mL in the concurrent plasma. Over a 0.15 to 3 g dose range in healthy adult subjects, the values of elimination half-life ranged from 5.8 to 8.7 hours; apparent volume of distribution from 5.78 to 13.5 L; plasma clearance from 0.58 to 1.45 L/hour; and renal clearance from 0.32 to 0.73 L/hour. Ceftriaxone is reversibly bound to human plasma proteins, and the binding decreased from a value of 95% bound at plasma concentrations of < 25 mcg/mL to a value of 85% bound at 300 mcg/mL. Ceftriaxone crosses the blood placenta barrier. The average values of maximum plasma concentration, elimination half-life, plasma clearance and volume of distribution after a 50 mg/kg IV dose and after a 75 mg/kg IV dose in pediatric patients suffering from bacterial meningitis are shown in Table 3 . Ceftriaxone penetrated the inflamed meninges of infants and pediatric patients; CSF concentrations after a 50 mg/kg IV dose and after a 75 mg/kg IV dose are also shown in Table 3 . Table 3. Aver
the following infectionsStaphylococcus aureusHaemophilus influenzae+6 more
2018
30
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
Post-LOE
INJECTION · INJECTABLE
2019
30
Open Jobs (0)
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Interview Prep Quick Facts
Portfolio: 3 approved products
Top TAs: Infectious Diseases
Portfolio Health
Post-LOE3 (100%)
3 total products