Industrial Pharmacy -BE and IVIVC

The following IVIVC establishes a single point relationship between an in vitro dissolution parameter and a pharmacokinetic parameter :

• A.

• B.

• C.

• D.

IVIVC approach during the discovery phase is __________.

• in silico simulation.

• animal pharmacokinetic testing.

• human pharmacokinetics testing.

Based on BCS, establishment of IVIVC is possible for Class 1 drugs if dissolution rate is __________ gastric emptying rate.

• slower than.

• faster than.

• equal to.

The recommended study design for bioavailability and bioequivalent studies is _____________.

• Cross over design.

• Parallel design.

• Retrospective cohort.

• Prospective cohort.

The following drug products can obtain a biowaiver:

• Oral solutions.

• Syrups.

• Tinctures.

• Soft capsules.

According to BCS, drug substances that are highly soluble but with low permeability are classified under Class

• 1

• 2

• 3

• 4

Other than lower strengths of a drug product, biowaivers are granted for

• solid formulations.

• solutions.

• BCS Class 2 drug substances.

• BCS Class 3 drug substances.

Which level of IVIVC could be used for granting biowaivers?

• A

• B

• C

• D

The following advantages are associated with IVIVC EXCEPT:

• To minimize unnecessary human testing.

• To decrease regulatory burden.

• To minimize cost.

• To set quality control.

For BCS class 1 drug substances, their absorption rate is likely to be controlled by

• dissolution rate.

• gastric emptying rate.

• permeability.

• disintegration time.