I. Basic Principles Part 2 (copy)

d. Zone 1

[STABILITY STUDIES]

The climate zone characterized by Temperate climate conditions

a. Zone 2
b. Zone 3
c. Zone 4a
d. Zone 1

c. Zone 2

[STABILITY STUDIES]

The climate zone characterized by Mediterranean/Subtropical climate conditions

a. Zone 1
b. Zone 3
c. Zone 2
d. Zone 4a

d. Zone 3

[STABILITY STUDIES]

Dry conditions

a. Zone 4a
b. Zone 1
c. Zone 4b
d. Zone 3

b. Zone 4a

[STABILITY STUDIES]

The climate zone characterized by Hot and Humid conditions

a. Zone 3
b. Zone 4a
c. Zone 4b
d. Zone 2

c. Zone 4b

[STABILITY STUDIES]

The climate zone characterized by Hot and Very Humid conditions

a. Zone 4a
b. Zone 3
c. Zone 4b
d. Zone 2

c. 21 ± 2°C / 45 ± 5% RH

[STABILITY STUDIES]

The temperature and relative humidity for Zone 1

a. 25 ± 2°C / 60 ± 5% RH
b. 30 ± 2°C / 35 ± 5% RH
c. 21 ± 2°C / 45 ± 5% RH
d. 25 ± 2°C / 45 ± 5% RH

d. 25 ± 2°C / 60 ± 5% RH

[STABILITY STUDIES]

The temperature and relative humidity for Zone 2

a. 21 ± 2°C / 45 ± 5% RH
b. 30 ± 2°C / 65 ± 5% RH
c. 30 ± 2°C / 60 ± 5% RH
d. 25 ± 2°C / 60 ± 5% RH

a. 35 ± 5% RH

[STABILITY STUDIES]

The relative humidity for Zone 3 (Hot and Dry)

a. 35 ± 5% RH
b. 65 ± 5% RH
c. 75 ± 5% RH
d. 45 ± 5% RH

c. 65 ± 5% RH

[STABILITY STUDIES]

The relative humidity for Zone 4a (Hot and Humid)

a. 35 ± 5% RH
b. 75 ± 5% RH
c. 65 ± 5% RH
d. 60 ± 5% RH

b. 75 ± 5% RH

[STABILITY STUDIES]

The relative humidity for Zone 4b (Hot and Very Humid)

a. 65 ± 5% RH
b. 75 ± 5% RH
c. 35 ± 5% RH
d. 60 ± 5% RH

d. Zone 3, Zone 4a, and Zone 4b

[STABILITY STUDIES]

The climate zones that share the same temperature of 30 ± 2°C

a. Zone 1 and Zone 2
b. Zone 2 and Zone 3
c. Zone 1 and Zone 3
d. Zone 3, Zone 4a, and Zone 4b

30 ± 2℃

[STABILITY STUDIES]

Temperature of Zone 3, Zone 4a, and Zone 4b

Aus

Japan

Korea

China

France

Italy

USA

[STABILITY STUDIES]

Zone 1 countries

Russia

Northern

Europe

Canada

[STABILITY STUDIES]

Zone 2 countries

Africa

Middle east (Iraq)

[STABILITY STUDIES]

Zone 3 countries

India

Brazil

Saudi

[STABILITY STUDIES]

Zone 4a countries

Philippines

[STABILITY STUDIES]

Zone 4b countries

c. Long-term Studies

[TYPES OF STABILITY STUDIES]

The type of stability study conducted under normal storage conditions

a. Accelerated Studies
b. Intermediate Studies
c. Long-term Studies
d. Real-time Studies

a. 30 ± 2°C, 75 ± 5% RH

[TYPES OF STABILITY STUDIES]

The storage conditions for Long-term Studies

a. 30 ± 2°C, 75 ± 5% RH
b. 25 ± 2°C, 60 ± 5% RH
c. 21 ± 2°C, 45 ± 5% RH
d. 40 ± 2°C, 75 ± 5% RH

c. Zero-order kinetics

• concentration independent

[TYPES OF STABILITY STUDIES]

The kinetics followed by Long-term Studies

a. First-order kinetics
b. Second-order kinetics
c. Zero-order kinetics
d. Michaelis-Menten kinetics

b. 0, 3, 6, 9, 12, 18, 24, 36, ...

[TYPES OF STABILITY STUDIES]

The testing periods for Long-term Studies

a. 0, 3, 6
b. 0, 3, 6, 9, 12, 18, 24, 36, ...
c. 0, 6, 12, 24
d. 0, 3, 6, 12, 24

0, 3, 6, 9, 12, 15, 18, 24, 36

• 12 – minimum time period

[TYPES OF STABILITY STUDIES]

minimum time period of the Long-term Studies

d. Accelerated Studies

[TYPES OF STABILITY STUDIES]

The type of stability study conducted under exaggerated storage conditions

a. Long-term Studies
b. Real-time Studies
c. Intermediate Studies
d. Accelerated Studies

c. 40 ± 2°C, 75 ± 5% RH

[TYPES OF STABILITY STUDIES]

The storage conditions for Accelerated Studies

a. 30 ± 2°C, 75 ± 5% RH
b. 25 ± 2°C, 60 ± 5% RH
c. 40 ± 2°C, 75 ± 5% RH
d. 21 ± 2°C, 45 ± 5% RH

b. First-order kinetics

• concentration dependent

[TYPES OF STABILITY STUDIES]

The kinetics followed by Accelerated Studies

a. Zero-order kinetics
b. First-order kinetics
c. Second-order kinetics
d. Michaelis-Menten kinetics

d. 0, 3, 6

[TYPES OF STABILITY STUDIES]

The testing periods for Accelerated Studies

a. 0, 3, 6, 9, 12
b. 0, 3, 6, 9
c. 0, 6, 12
d. 0, 3, 6

c. 6 months

[TYPES OF STABILITY STUDIES]

Time point used to extrapolate a product with a 2-year stability in accelerated studies

a. 1 month
b. 3 months
c. 6 months
d. 12 months

a. Stress testing Studies

[TYPES OF STABILITY STUDIES]

Elucidates the intrinsic stability of the drug and identify the likely degradation products

a. Stress testing Studies
b. Real-time Studies
c. Intermediate Studies
d. Accelerated Studies