What does the term bioequivalence mean?
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 a bioavailability study?
The bioavailability studies are done by measuring the concentration of the drug in the plasma or blood after administration of drug following systemic protocol of studies and documented over time.
What is meant by Biowaiver?
A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval).
What is a bioequivalence study?
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. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
What is the difference between bioequivalence and bioavailability?
For a drug to be highly bioavailable it should be fast and completely absorbable. Bioequivalence is Just a comparison of the bioavailability of two identical products. For example, we compare two brands of paracetamol (Acetaminophen) for their bioavailability.
What is difference between bioavailability and bioequivalence?
Bioavailability studies focus on determining the process and time frame by which a drug substance is released from the oral dosage form and moves to the site of action. On the other hand, bioequivalence studies focus on the performance of the drug product and usually involve comparisons of two drug products: T and R.
What is biowaiver PPT?
The term “biowaiver” is applied to a regulatory drug approval process when the dossier (application) is approved based on evidence of equivalence other than through In-vivo equivalence testing.
What is a BCS biowaiver?
BCS-based biowaivers are applicable to drug products where the drug substance or substances exhibit high solubility and, either high permeability (BCS Class I) or low permeability (BCS Class III). A biowaiver is applicable when the drug substance(s) in test and reference products are identical.
What is pharmacokinetics and pharmacodynamics definition?
In simple words, pharmacokinetics is ‘what the body does to the drug’. Pharmacodynamics describes the intensity of a drug effect in relation to its concentration in a body fluid, usually at the site of drug action. It can be simplified to ‘what the drug does to the body’.
Which is the definition of the term pharmacology?
Definition of pharmacology 1 : the science of drugs including their origin, composition, pharmacokinetics, therapeutic use, and toxicology. 2 : the properties and reactions of drugs especially with relation to their therapeutic value.