10 Important BCS System MCQ

BCS System MCQ– Drug permeability and solubility have more research applications now thanks to the Biopharmaceutical Classification System (BCS).

The U.S. Food & Drug Administration’s drug development process has made it abundantly clear that drug absorption depends on bioavailability and bioequivalence. In the early stages of drug development, the Biopharmaceutical Classification System (BCS) is a useful tool for making decisions.

The BCS was initially developed in 1995 and quickly became a standard in the management of oral dosage form bioequivalence. The BCS is a scientific classification system that uses two criteria to categorize drug substances-

*Solubility
*Permeability

The solubility of the drug substance will not be a governing factor if the drug substance’s absorption is permeation rate limited, so the in vitro dissolution study can be used to show the drug product’s bioavailability (BA) or bioequivalence (BE) through an in vitro-in vivo correlation (IV-IVC).

Each class of BCS has a unique rate-limiting step with the option to modify it, allowing the formulator to choose and optimize a particular dosage form for the drug substance that belongs to that class.

Since the BCS was founded, there have been numerous revisions made to the BCS guidelines, increasing the likelihood that they will be used in the development of drugs with the desired properties. In the early stages of drug development, it is especially important to use BCS to identify the rate-limiting step in the oral absorption process and to provide formulation scientists with crucial details about the entire drug development process.

BCS is helpful for the early stages of molecule development in addition to being a regulatory tool. Successful use of the BCS concept to support gives the impression that there is a lack of common understanding due to the substantial differences in bio-waiver dossiers and respective assessments.

10 Important BCS System MCQ

Q.1 Biopharmaceutics classification system classifies the drugs into one of the groups.
(a) 1
(b) 2
(c) 3
(d) 4

Q. 2 According to Biopharmaceutics Classification System ,Class II drugs have
(a) High Solubility/ High Permeability
(b) Low Solubility/ High Permeability
(c) High Solubility/ Low Permeability
(d) Low Solubility/ Low Permeability

Q.3 Which BCS class shows High Solubility and Low permeability?
(a) BCS Class |
(b) BCS Class II
(c) BCS Class III
(d) BCS Class IV

Q.4 According to Biopharmaceutics Classification System,Class IV drugs have
(a) High Solubility/ High Permeability
(b) Low Solubility/ High Permeability
(c) High Solubility/ Low Permeability
(d) Low Solubility/ Low Permeability

Q.5 A drug substance is considered to be highly permeable when the systemic bioavailability is
(a) 80% or more
(b) 85% or more
(c) 90% or more
(d) 100% or more

Q.6 A drug substance is considered highly soluble when the highest strength is soluble in
(a) 200 ml
(b) 250 ml
(c) 300 ml
(d) 500 ml

Q.7 A drug with high permeability is the one having extent of absorption greater than___ % of the
administered dose given that the drug is stable in the gastrointestinal environment.
(a) 90
(b) 95
(c) 100
(d) 105

Q.8 Drug with high absorption number have_____ permeability.
(a) Low
(b) High
(c) Both
(d) None of above

Q.9 Drugs with low absorption number have ____permeability.
(a) Low
(b) High
(c) Both
(d) None of above

Q. 10 What is the respective time period taken for completion of Clinical trial studies in order Phase 1: Phase II: Phase III?
(a) 3-6 months: 6-12 months: 1-2 months
(b) 6-12 months: 1-2 months: 2-5 months
(c) 1-2 months: 2-3 months: 3-5 months
(d) 3-6 months: 6-12 months: 2-3 months

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