science of pharmacology

Question 1

vitro

vivo

Answer 1

vitro is the procedures tests and experiments performed outside a living organism while Vivo are procedures that take place in the living organism

Question 2

importance of pharmacology in drug development (5)

Answer 2

1. discovering new medicines to help fight life-threatening diseases.
2. improving efficacy (ability to produce desired results) and safety of medicine.
3. reducing unwanted or untoward side effects of the medicine.
4. exploring the interactions between medications which may cause synergism ( cooperation between two organizations) and antagonism ( active hostility)
5. determining why individuals differ in the way they respond to drugs.

Question 3

advantages of pharmacology. (6)

Answer 3

1. Good health. Effective medicines and good pharmacological research reduces pain, suffering, symptoms, and the economic woe that comes with sickness.
2. Enhances people’s living standards. Pharmacology helps in the treatment and prevention of diseases and provides information to assist people to live longer and better lives.
3. helps doctors use drugs on a therapeutic rational basis. Before doctors were reluctant to use scientific principles in therapeutic treatment.
4. pharmacological understanding of drugs helps predict the effect of a new chemical.
5. Pharmacology has provided new techniques such as drug design, genetic screening, protein engineering, and the use of novel drug delivery systems (NDDs)
6. Helps in the development of future drugs. Pharmacovigilance provides detection, assessment, monitoring, and prevention of adverse side effects of drugs.

Question 4

pharmaceutical formulation.

Answer 4

The process in which an active drug is combined with an inactive excipient to produce a medical drug.

Question 5

factors to be considered in pharmaceutical formulation. (4)

Answer 5

1. particle size
2. polymorphism (different forms the drug can take)
3. pH
4. solubility

Question 6

Effects of pharmaceutical formulation on the patient. (3)

Answer 6

1. patient’s quality of life.
2. disease outcome
3. adherence to treatment protocols.

Question 7

Factors affecting the effectiveness of the pharmaceutical formulation. (4)

Answer 7

1. Drugs chemical properties.
2. Excipient’s properties.
3. Dosage
4. Mode of administration.

Question 8

First considerations in pharmaceutical preparation.

Answer 8

1. Drug stability
2. Palatable ( pleasant to taste)
3. the drug is acceptable to the patient.

Question 9

Why is it necessary to develop an occasional complexity regimen for maximum effectiveness when complex regimens are involved?

Answer 9

More complex regimens show a decreased patient compliance.

Question 10

definition of drug design.

Answer 10

The method of manufacturing a novel or new medical product

Question 11

definition of rational drug design.

Answer 11

the process through which a new product is planned to completely support the knowledge of the biological target.

Question 12

Requirements of pharmaceutical formulation (11)

Answer 12

1. Should provide a drug that bypasses the first-pass metabolism in the liver and reaches the systemic sites e.g injections, forms, tropical dosage.
2. Should prevent deteriorating of drug substances when exposed to oxygen or humidity e.g through coated tablets
3. Should prevent Active Pharmaceutical Ingredients ( APIs)from deteriorating due to gastric acid if administered orally in dosage form. e.g enteric coated tablets
4. To mask the bitter, salty or undesirable taste so that the drug is palatable and is easily accepted by patients e.g flavored syrup
5. To provide a useful dosage form for administering APIs that are insolubly unstable in the desired vehicle e.g using suspensions
6. To supply medications that are stable, effective and safe for consumptions under specified storage conditions.
7. To provide optimal drug action from topical administration sites e.g creams
8. To supply clear, sterile and particulate-free liquid dosage sorts of substances e.g eye drops
9. To provide site-specific and native drug delivery e.g rectal and vaginal suppositories
10. to focus the drug on the specified sites.
11. To achieve rapid onset of action with inhalation therapy using inhalants

Question 13

Why are pharmaceutical laws and regulations necessary?

Answer 13

Because the utilization of ineffective, poor quality or harmful medicines may result to:

1. Therapeutic failure
2. Exacerbation of the disease.
3. Resistance to medicines
4. Death.

Question 14

Examples of Pharmaceutical Markets across the world ( Regulated, semi regulated and non- regulated)

Answer 14

regulated- US, European Union (EU), Japan ( follows the International Council for Harmonization) ICH pattern.
Semi-regulated- India, Asian countries, RUSSIA, China, Brazil where country specific product registration are followed.
Non-regulated- African countries ( Minimal documentation is required for the drug approval process)

Question 15

Various laws and amendments under the FDA (7)

Answer 15

1. virus toxin law, 1902
2. Food and drug act, 1906
3. Federal Food, Drug and Cosmetic act, 1938
4. Durham-Humphrey amendment, 1951
5. Kefauver- Harris amendment, 1962
6. Medical device amendments, 1976
7. Medical amendments, 1976
8. Anti-Tampering regulations, 1982

Question 16

What is the ‘Bioresearch Monitoring (BIMO) Program

Answer 16

This is an FDA program that does on-site inspections to ensure the quality and integrity of the data of regulated clinical trials of drugs, devices and biologics submitted to the agency.

Question 17

Inspections conducted by the FDA under the BIMO program.

Answer 17

1. CDRH- Centre of devices and Radiologic health
2. CDER- Centre of Drug evaluation and research.
3. CBER- Centre of Biologics evaluation and research.
   CVM - Centre of Veterinary Medicine.

Question 18

Need for the ICH(3)

Answer 18

1. Many drug procedures are time consuming and expensive.
2. Rising costs of health care to make safe new treatments available to patients.
3. Country-wise divergence in technical requirements .

Question 19

Objectives of the ICH. (7)

Answer 19

1. To promote public health by early availability of drugs in the market.
2. To help in maintaining safeguards on quality, safety and efficacy.
3. To play an important role in improving the efficiency and safety of new drug development and reduce registration costs.
4. To provide less expensive drugs to patients.
5. To mandate strict rule to prevent clinical trials duplication in humans.
6. To restrict animal use without compromising safety and efficacy of the product.
7. To play a vital role in reducing testing duplication.