WorksheetsIndustrial Pharmacy -BE and IVIVC
Total questions: 15
Worksheet time: 10mins
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.
A washout period in a cross-over design of BE study should exceed _______________ of the active moiety measured.
2 half-life.
3 half-life.
4 half-life.
5 half-life.
Parallel designs are recommended for BE studies when
chemotherapeutic drugs are used.
the drug half-life so long.
patients are involved.
high dose of the drug are used.
The following pharmakokinetics parameters are statistically analysed for determination of BE EXCEPT:
AUC.
Cmax.
Vd.
Tmax.
The following statements regarding IVIVC are true EXCEPT:
IVIVC is used to determine developability of a compound.
In tier 1, IVIVC is usually conducted through in silico simulation.
In tier 2, human pharmacokinetics data are available.
In tier 4, IVIVC is applied as part of development strategy for life-cycle management.
BCS is a scientific framework for classification a drug substance based on its
aqueous solubility.
membrane permeability.
dissolution.
polarity.
