Concept of generic drugs and its ingredients
A generic drug is a pharmaceutical creation, generally proposed to be interchangeable with a brand product, manufactured without a license from the innovation company and marketed after the patent expiration date or other exclusive rights.
Generic products can also be termed as multisource products. And you will often see the chemical name of a drug termed as "generic" or "non-proprietary" name, which has been described could lead to confusion among consumers who can only know their prescription only from the brand name.
The active pharmaceutical ingredient (API)
The drugs that have an API enable generic drugs to be promoted because when we compare generics, the API is the same. Instead, consider the scenario of an herbal remedy. A single 100 mg raw herb tablet could contain hundreds of different chemicals. If there are no known APIs or standardized active ingredients, we may not be able distinguish between brands or assume that clinical trials with a brand are relevant to any other product because we have no idea which ingredient is actually producing an effect and if any other version has the same ingredient (or a combination of ingredients).
Bioavailability
Most dosage forms (e.g. tablets and capsules) are designed to provide the API to the action site. Unless it is a drug that acts directly on the lining of the gastrointestinal tract, we rely on the circulatory system to bring the drug to the site of action in the body. Bioavailability is the amount of drug that, once ingested, reaches the bloodstream.
Bioequivalence
Two products are said to be bioequivalent when the rate and extent of absorption of the generic drug do not show a significant difference with respect to the rate and extent of absorption of the brand name drug when administered at the same dose under similar experimental conditions.
Conclusion
The science of generic bioequivalence assessments has been implemented in most countries for over 20 years with a proven track record of therapeutic equivalence. These assessment methods have been so successful in setting generic drug standards that are broadly consistent across all major drug regulators worldwide. Both healthcare professionals and customers can be reassured that generic drugs approved under this regulatory guidance are effectively bioequivalent and, therefore, interchangeable with branded products.
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