By Sarfaraz K. Niazi

Because the general pharmaceutical keeps to develop and thrive, so does the necessity to behavior effective and profitable bioequivalence reports. in recent times, there were major adjustments to the statistical types for comparing bioequivalence, and advances within the analytical expertise used to notice drug and metabolite degrees have made bioequivalence checking out tougher to behavior and summarize. The instruction manual of Bioequivalence trying out deals a whole and well timed description of each element of bioequivalence checking out, together with all over the world regulatory requisites for submitting for approval of widespread medicines, making use of for a waiver, securing regulatory approval of news, and acquiring regulatory certification of amenities engaging in bioequivalence reviews.

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Additional info for Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)

Example text

The pioneer product should have an adequate margin of safety at the higher than approved dose level. , through literature) that the drug follows linear kinetics. A higher than approved dose BE study in food animal species would be accompanied by a tissue residue withdrawal study conducted at the highest approved dose for the pioneer product. , therapeutic and production claims), a single BE study at the highest approved dose will usually be adequate. However, multiple BE studies at different doses may Chapter 1: BE Testing Rationale and Principles 13 be needed if the drug is known to follow nonlinear kinetics.

In addition, a traditional hypothesis test should be performed comparing both the test and reference products separately to the placebo (or negative) control. The hypothesis test is conducted to ensure that the study has adequate sensitivity to detect differences when they actually occur. , the mean of the test and the mean of the reference products are each not significantly better than the mean of the placebo (or negative) control], generally, the study will be considered inadequate to evaluate BE.

For pharmacologic effects, for which effect versus time curves cannot be generated, then alternative procedures for statistical analysis should be discussed with the FDA prior to conducting the study. , most production drugs and some coccidiostats and anthelmintics), then well-controlled clinical end-point studies are acceptable for the demonstration of BE. Generally, a parallel group design with three treatment groups should be used. The groups should be a placebo (or negative) control, a positive control (reference/pioneer product), and the test (generic) product.

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