Chapter 5

Question 1

__________ are safe and effective alternatives to brand name prescription

Answer 1

Generic drug

Question 2

Advantage of generic drug:

Answer 2

can help both consumers and the government reduce the cost of prescription drugs

Question 3

Brand drug / original:

Answer 3

1. Chemistry
2. Manufacturing
3. Controls
4. Labeling
5. Testing
6. Animal Studies
7. Clinical Studies

Question 4

Generic drug:

Answer 4

1. Chemistry
2. Manufacturing
3. Controls
4. Labeling
5. Testing
6. Bioequivalence Study (In Vivo, In vitro) - مهمة تنعمل لكل دواء مصنع

Question 5

Definitions/ requirements- Generic drug:

Answer 5

1. Same active ingredient
2. Same rout of administration
3. Same strength (concentration)
4. Same indication (use)
5. Same dosage form

Question 6

___________ is a drug product approved in a new drug application according to the FDA regulation, based on full reports of
investigations of safety and effectiveness.

Answer 6

RLD- Reference listed drug (brand drug)

Question 7

_______ absences of a significant different in rate and extent which the active ingredient in pharmaceutical equivalents

Answer 7

Bioequivalence
هي انه ما يكون في فرق بين البراند والجينيرك بال rate وهي وينتا وصل الدم وال extent قدي وصل الدم وقتها بسميهن equivalence

Question 8

___________ pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

Answer 8

Bioequivalence
- same rate and extent for both drug generic and extent.

Question 9

Goals of bioequivalence:
- to ensure product on the market is comparable to that upon which the efficacy is based:

Answer 9

1. Establishe that a new generic drug has therapeutic equivalence in rate and extent of absorption to the reference drug product.

Question 10

The factors that may lead to differences between drugs have a same active ingredient: (low bioavailability- bio in equivalence)

Answer 10

1. Dissolution
2. Absorption
3. Metabolism

Question 11

________ The rate and extent at which its active ingredient is delivered from pharmaceutical form and becomes available in the systemic circulation

Answer 11

Bioavailability

Question 12

4 possible differences between the brand and the generic drug:

Answer 12

صفحة 11 ضروري

Question 13

Study design for bioavailability:

Answer 13

We take two groups (10 animals each).
First, one group gets the brand drug, the other gets the generic drug.
We collect blood and creat the curve.
After that, we perform a crossover , switch the first group gets the generic, the second gets the brand.

Question 13

Effective and safety

Answer 13

If the generic drug reaches the bloodstream with the same extent and rate as the brand drug, then its effect and safety will be the same, and there is no need for animal testing.

Question 14

What is the purpose of the two-way crossover?

Answer 14

1. Reduce number of experimental animal
2. Reduce bias
3. Reduce variation

Question 15

Duration of washout / withdrawal period for cross-over design:

Answer 15

should be approximately > 5 times the plasma apparent terminal half-life
Why?
- To ensure that the first dose is no longer present in the blood and does not affect the results of the second dose.

Question 15

Study single dose:

Answer 15

In case crossover is difficult or the drug has a long withdrawal period, we use a single-dose design: each group receives only one type of the drug.

Question 16

Bioequivalence of drug:

Answer 16

80% - 125% T/R = اذا كانت الادوية بين هاي الفترات فهني مكافئات
- Confidence interval

Question 17

Measurement drug concentration, Method Validation should include الطريقة الي دفحص فيها لازم تضمن

Answer 17

1. Accuracy
   2.sensitivity
2. Specificity
3. Recovery
4. Stability

Question 18

______ Closeness of determined value to the true value

Answer 18

Accuracy

Question 19

________ The limit of quantitation is the lowest concentration which can be measured with acceptable accuracy and precision.

Answer 19

Sensitivity

Question 20

________ Ability of the method to measure only what it is intended to measure in the presence of other components in the sample.

Answer 20

(Specificity )Selectivity

Question 21

__________ During, sample collection , sample storage and sample analysis process, the stability of drug in matrix should be conducted.

Answer 21

Stability

Question 22

Shelf life:

Answer 22

The period during which the drug’s amount does not decrease below 95% of its initial concentration.

Question 23

High Performance Liquid Chromatography (HPLC)

Answer 23

HPLC works by pumping a liquid sample through a column (stationary phase), using a liquid (mobile phase) under high pressure. Different compounds in the sample exit the column at different times — called retention times. According to size and polarity

Question 24

_______ processes can be defined as separation techniques involving mass-transfer between stationary and mobile phases.

Answer 24

Chromatographic

Question 25

The time taken for a particular compound to travel through the column to the detector is known as its __________

Answer 25

Retention time

Question 26

Basic HPLC Components

Answer 26

1. Mobile phase - Solvents) that carry the sample through the column. 2. Pump - Pushes the mobile phase and sample through the system. 3. Stationary phase (Column) - Where separation occurs according to size and polarity. 4. Detector - Measures the compound as it comes out of the column.

Question 27

How to Read HPLC Results (Chromatogram):

Answer 27

- is a graph showing the Y-axis which shows how much of a compound is detected vs. time (x-axis). 1. Retention time 2. Peak concentration - The system stores the retention time and peak data of drugs as standards.