What is the difference between bioequivalence and pharmaceutical equivalence?

Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately …

Is bioequivalence and the therapeutic equivalence are same?

When two formulations of the same drug or two drug products are claimed bioequivalent, it is assumed that they will provide the same therapeutic effect or that they are therapeutically equivalent. In this case, most people interpret that they can be used interchangeably.

What is meant by bioequivalence?

Bioequivalence is the property of two dosage forms or active ingredients with similar blood concentration levels that produce the same effect at the site of physiologic activity.

What is the difference between AB1 and AB2?

Thus, if a branded product is rated “AB1” only generics that are rated “AB1” are deemed therapeutically equivalent to that branded product. Similarly, if the other branded product is rated “AB2”, therapeutically equivalent generics will be rated “AB2”.

What is bioequivalence pharmacokinetics?

What Is Bioequivalence? Bioequivalence is the biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients. Pharmacokinetic studies must be done to determine whether a commercially available brand and a potential generic version share core attributes.

How is bioequivalence determined?

Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. It is measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine where equality is 1.

What is 90 confidence interval in bioequivalence?

A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%).

What is the importance of bioequivalence?

Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.

What is the difference between a biologic and a biosimilar?

Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.

What is the difference between a biosimilar and an interchangeable product?

An interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act.

What is needed for bioequivalence?

A minimum number of 12 evaluable subjects should be included in any bioequivalence study. When an average bioequivalence approach is selected using either non-replicated or replicated designs, methods appropriate to the study design should be used to estimate sample sizes.

Are AB1 and AB2 interchangeable?

What are BA and BE studies?

BA/BE (Bioavailability & Bioequivalence) Studies. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

Where did the 80 to 125 bioequivalence criteria come from?

The basis for the 80-125% range is arbitrary … sort of. The FDA (and other regulatory bodies) “decided” that differences in systemic drug exposure up to 20% are not clinically significant. Now, that may lead you to believe that the appropriate range should be 80-120% (100% ± 20%) … but that isn’t the range.