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Ampicillin is an antibiotic belonging to the aminopenicillin class of the penicillin family. The drug is used to prevent and treat several bacterial infections , such as respiratory tract infections , urinary tract infections , meningitis , salmonellosis , and endocarditis . [ 7 ]
C max is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose. [1] It is a standard measurement in pharmacokinetics.
Ampicillin/sulbactam can be used to treat gynecological infections caused by beta-lactamase producing strains of E. coli, and Bacteroides spp. (including B. fragilis). [2] [4] Bone and joint infections Ampicillin/sulbactam can be used in the treatment of bone and joint infections caused by susceptible beta-lactamase producing bacteria. [5] [6 ...
For FDA approval, a generic manufacturer must demonstrate that the 90% confidence interval for the ratio of the mean responses (usually of AUC and the maximum concentration, C max) of its product to that of the "brand name drug" is within the limits of 80% to 125%.
A V D greater than the total volume of body water (approximately 42 liters in humans [5]) is possible, and would indicate that the drug is highly distributed into tissue. In other words, the volume of distribution is smaller in the drug staying in the plasma than that of a drug that is widely distributed in tissues.
For an ANDA to be approved, the FDA requires that the 90% confidence interval of the geometric mean test/reference ratios for the total drug exposure (represented by the area under the curve or AUC) and the maximum plasma concentration (Cmax) should fall within limits of 80–125%. [42] (This range is part of a statistical calculation, and does ...
An antibiotic is a type of antimicrobial substance active against bacteria.It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of such infections.
C min is a term used in pharmacokinetics for the minimum blood plasma concentration reached by a drug during a dosing interval, which is the time interval between administration of two doses. This definition is slightly different from C trough , the concentration immediately prior to administration of the next dose. [ 1 ]