What is the difference between pharmaceutical equivalent and therapeutic equivalence?
What is the difference between pharmaceutical equivalent and therapeutic equivalence?
Therapeutic Equivalents: Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
What is meant by therapeutic equivalence?
Approved drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
What is pharmaceutical equivalence Mcq?
Explanation: Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics.
What do bioequivalence means?
2 Bioequivalence is generally used to establish similarity between a generic drug and reference drug and is defined as the absence of significant differences in the availability of the active ingredient at the site of drug action.
What is clinical equivalence?
A clinical equivalence study is one where the aim is to show that the outcome for the two (or more) technologies studied differs by a clinically unimportant amount.
Why is therapeutic equivalence important?
The purpose of establishing if two medications are therapeutic equivalents is to allow the generic drug to go through a shorter, more cost-effective, approval process while still protecting public safety. For a drug to be approved as a therapeutic equivalent it must: Be safe and effective.
What do you mean by bio equivalence studies and its acceptance criteria?
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters.
What is chemical equivalent Mcq?
Explanation: Chemical equivalence of drug products is said when the drugs contain the same active ingredient. The amount of the active ingredient must be the same. When two or more drug products contain the same active ingredient giving the same pharmacologic effect is known as therapeutic equivalence.
What makes a drug 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 …
How are bioequivalence studies conducted?
Bioequivalence studies can be conducted in a non-replicated or replicated fashion. The standard two-period, two-formulation, two-sequence crossover study uses a non-replicated design. In terms of statistical analysis criteria, therefore, an average bioequivalence approach is generally sufficient.
What is an example of therapeutic equivalent?
Examples of therapeutically equivalent medications are widespread and include both prescription and over-the-counter (OTC) medications, which are options available without the need for prescriptions.
What does pharmaceutical equivalence mean?
Pharmaceutical equivalence implies the same amount of the same active substance (s), in the same dosage form, for the same route of administration and meeting the same or comparable standards.”
What is therapeutic equivalence?
Therapeutic equivalence is established by meeting certain criteria. This involves determining if the new alternative has the same active ingredients, potency and performance. Other important considerations are whether the generic is administered and if the body responds in the same way as the brand-name product.
What is pharmaceutical quality?
The Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public. OPQ integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale.
