Biological Assay Validation
Recent revision intends to make changes based on feedback from stakeholders since the last revision…
Recent revision intends to make changes based on feedback from stakeholders since the last revision…
Heat transfer means heat energy is transferred from a region of higher temperature to a region of…
Density is defined as the mass of a substance in air at a specific temperature (typically 25°) per …
The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an indi…
Impurity is a component of any drug product that is not the drug substance or an excipient in the d…
The quantities of electrolytes administered to patients are usually expressed in terms of mEq. Weig…
Pharmacutical batch reconciliation is a process which is used to calculate and monitor the process …
Calculating dosing by weight A physician orders azithromycin for oral suspension at a dose of 15 mg…
Bioassays are methods employed to estimate the effect of a given substance in living matter, and th…
Production yield is a value in % that results from dividing the number of good units (output) by th…
Potency of drug means amount of drug needed to produce an effect of given intensity. It also indica…
As per 21 CFR 210.3, batch is a certain amount of a drug product that is intended to have a uniform…
Label claim of a pharmaceutical product means the statement on a drug product about the amount of A…
Clinical calculations are critical to the delivery of safe, effective, and competent patient care a…