What is meant by bioequivalence?
Bioequivalence is defined as ‘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 …
When are drugs bioequivalent?
Two drug products are said to be bioequivalent if they are pharmaceutical equivalents (i.e., similar dosage forms made, perhaps, by different manufacturers) or pharmaceutical alternatives (i.e., different dosage forms) and if their rates and extents of absorption do not show a significant difference to which the active …
What is difference between bioavailability and bioequivalence?
Bioavailability of a drug is the proportion that can reach the circulation in its unchanged form (API) and have an active effect. The rate and extent of absorption is called as bioavailability. Bioequivalence is the comparison of bioavailability between two drug formulations.
Are generic drugs bioequivalence?
In addition to being pharmaceutically equivalent, generic drugs must also be “bioequivalent” to the brand name drug. That means the generic drug will work in the body in the same way (same amount goes into the body within the same time frame) and be as safe and effective as the brand name drug.
What is bioequivalence example?
Bioequivalence, according to the FDA’s report, is the absence of a significant difference in the rate and extent that an active ingredient in pharmaceutical equivalents has contact with the site of the drug’s action. For example, it must prove a once-a-week tablet is bioequivalent to a daily tablet.
How is bioequivalence calculated?
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 are the disadvantages of generic drugs?
Cons of generic drugs:
- Patients perceive them as inferior to branded drugs.
- If they’re not co-formulated, higher pill burdens may deter adherence.
- Overall co-payments for a regimen could result in higher costs to patients.
- They may have a different pill size/color when generic suppliers change.
Do generic Drugs have clinical trials?
Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand-name drugs.
How is bioequivalence tested?
Bioequivalence is most often measured directly by comparing pharmacokinetic parameters following dosing (AUC and Cmax). If drug levels cannot be measured, a pharmacodynamic approach may be employed, comparing therapeutic responses and side effect profiles in patients at equivalent doses.
What is the requirement for bioequivalence?
The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC(0-t) and AUC(0-∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80.00% to 125.00% in the fasting state.
What are generic or bioequivalent drugs?
A generic drug is identical–or bioequivalent–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
Are generic drugs equivalent to brand-name drugs?
In the United States, trademark laws do not allow generic drugs to look exactly like the brand name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other inactive ingredients may be different but the effectiveness of the drug remains the same.
What are generic names for drugs?
Generic name is the name frequently used by the doctors when prescribing a drug. For an instance, a doctor may prescribe lansoprazole, which is the generic name, and the patient can purchase either generic lansoprazole, Prevacid, Helicid or Zoton etc., which are commercial trade names of the same drug. Generic name is unique and universal.
What is AB rated generic?
AB Rated Generic means a Third Party’s product which is deemed by Health Canada to be the therapeutic equivalent of the Product and which contains the same Active Ingredient as the Product.