By Sarfaraz K. Niazi
Because the favourite pharmaceutical keeps to develop and thrive, so does the necessity to behavior effective and profitable bioequivalence stories. in recent times, there were major alterations to the statistical types for comparing bioequivalence, and advances within the analytical know-how used to realize drug and metabolite degrees have made bioequivalence checking out more challenging to behavior and summarize. The instruction manual of Bioequivalence checking out bargains a whole and well timed description of each element of bioequivalence checking out, together with world wide regulatory specifications for submitting for approval of established medicines, utilising for a waiver, securing regulatory approval of stories, and acquiring regulatory certification of amenities carrying out bioequivalence reviews.
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Extra info for Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
Example text
A single-dose study at a higher than approved dose may be appropriate for certain drugs. , a drug with nonlinear kinetics) or a drug with a narrow therapeutic window. A multiple-dose study may also be needed when assay sensitivity is inadequate to permit drug quantification out to three terminal elimination half-lives beyond the time when maximum blood concentrations (Cmax) are achieved, or in cases where prolonged or delayed absorption exist. , flip-flop kinetics) may be made from pilot data, from the literature, or from information contained with Freedom of Information summaries pertaining to the particular drug or family of drugs.
Blood). The following aspects should be addressed in assessing method performance. Concentration Range and Linearity The quantitative relationship between concentration and response should be adequately characterized over the entire range of expected sample concentrations. For linear relationships, a standard curve should be defined by at least five concentrations. If the concentration response function is nonlinear, additional points would be necessary to define the nonlinear portions of the curve.
Less than a twofold difference in median lethal dose and median effective dose values (or less than a twofold difference in the minimum effective concentration and minimum toxic concentration in the blood), require careful demonstration of BA and the consistency with which this requirement is met. Further consideration is needed in the type of side effects occurring if a toxic level is reached. S. FDA prefers to call this therapeutic range) for salicylates is smaller than cardiac glycosides; it does not mean that cardiac glycosides are less toxic.