Pharmacology: An Introduction: Pharmacology Dr. Abdul Salam Nazmi

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Pharmacology: An Introduction

Pharmacology
Dr. Abdul Salam Nazmi

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History of Pharmacology
• Look for Agents: to relieve pain and diseases

• Early days of therapeutics:


– Magic, Religion and Divine intervention
• Experiences: coming with time
– foundation for = science- based practice

• Chinese: 5000 years ago


• Egyptians: 3500 years ago
– a list of drugs and recipes to make them
– now called as Formularies 2
Origin of Pharmacology: 16th Century

3 Principles of Pharmacology:
1. Each disease:
a specific cause & a specific remedy

2. Each remedy (natural):


an identifiable component --- responsible for its efficacy

3. Size of the dose:


determines the degree of response

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Modern Pharmacology: 19th century

• Critical idea: for the development of modern


Pharmacology:-
– specific chemicals produce biological responses

• The concept was facilitated:


– development of techniques
– isolation and synthesis of pure organic chemicals
in the 19th century

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Key figures in the development of
Pharmacology in the 19th century

• Serturner (1804): isolated morphine

• Wells (1845): nitrous oxide

• Morton (1846): diethyl ether

• Binz (late 1800's): cyanide poisoning and quinine.

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Key figures…..

Rudolph Bucheim:
1820-1879

• established the first


Department of
Pharmacology at the
University of Dorpat (now
in Estonia)

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Professor Oswald Schmiedeberg

 Oswald Schmiedeberg:
1838-1921
• 1866 Dr. med. in Dorpat
• 1866-1868 in Dorpat studied with
Rudolf Buchheim
• 1869-1872: Pharmacologist in
Dorpat
• 1872-1918: Pharmacologist in
Strasburg
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Roots of U.S. Pharmacology
• John J. Abel (1857-1938)
– Established 1st US Department of
Pharmacology at the University of Michigan
• 1st Chairman of Pharmacology at Johns
Hopkins University (JHU)
• Founded:
– American Biochemical Society (ABS)
– American Society for Pharmacology and
Experimental Therapeutics (ASPET)

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Terminology
• Pharmacology: is the study of the interaction of chemicals
with biological systems to yield therapeutic or other
beneficial effects

Pharmacon + logos

• The science in which we study how drugs produce their


effects on the human body.
• Aim:
– safety of medicines
– effective use of drugs

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Terminology…
• Major areas of Pharmacology:

1. Pharmacodynamics:
–mechanism of action of drugs

2. Pharmacokinetics:
– Absorption, Distribution, Metabolism, Elimination

3. Pharmacotherapeutics:
– treatment of diseases

4. Chemotherapy:
– use of drugs to destroy or retard growth
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Terminology…
• Toxicology:
– study of the interaction of chemicals with biological
systems to yield adverse effects (harmful effects of drugs)

• Pharmacy:
– The science of preparing, compounding, and dispensing
medicines

• Pharmacognosy:
– The identification and preparation of crude drugs from
natural sources

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Pharmacology: Important Concepts
• Drugs cannot change the function of a cell, tissue or
organ.

• an understanding of organic chemistry, biochemistry,


physiology, pathology, and microbiology

 They can only stimulate or depress an


already existing function.

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Categories of drugs
• Traditional (chemical) drug therapies:
- most common
- single compound either isolated or synthesized in a lab

• Biologics:
- produced by animal cells or microorganisms
- hormones, vaccines, compound found in blood

• Natural/Alternative therapies:
- herbs & plant extracts, vitamins/minerals, animal extracts

- widely used? not under same Scanner as drugs

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Drug Nomenclature
• Chemical name:
— Used by chemists
— as per chemical configuration
— Example: 2-(4-(2-methylpropyl)phenyl) propionic acid

• Generic name:
— assigned by the US Adopted Name Council (USAN)
— useful to know (study of drug by generic name only)
— Example: ibuprofen

• Trade name or Brand name:


— assigned by the company/manufacturer
— A drug can have more than one trade names
— Example: Ibuprofen® (Arthrofen, Ebufec, Remafen, Fenbid)

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Drug Regulation in USA
• Drug Control: FDA
-The Food and Drug Administration:
 Chemical drugs, biologics, herbs, medical devices, as well as food,
cosmetics, veterinary medicines, and animal feeds etc.
 Monitors adverse effects of drugs

• Drug Development: Divided into two Phases


– 1. Pre-Clinical Stage – begins with testing in cell culture and
animals
– 2. Clinical Stage – very expensive and begins with testing in
humans

 If pre-clinical testing shows promise, clinical trials in human


begin
 Averages time-span = about 10 years (8-12)
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Four Phases of Clinical Trials
 Primary consideration: to provide welfare of subjects
 Good Clinical Practice (GCP) Guidelines:
 by establishing IRB and ICF
 CTs: four phases

• Phase 1: Human Pharmacology


– small number of healthy normal volunteers (20-80)
– patients ?
– safety of drug and toxicity dose

• Phase 2: Therapeutic exploration


– small number of patients (80-200)
– effectiveness of drug
– optimal dose range (dose-response studies)

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Four Phases of Clinical Trials..

• Phase 3: Therapeutic confirmation


– large number of patients (100-1000s)
– verify the efficacy of the drug
– look for additional side effects

• Phase 4: Therapeutic use


– Additional information after marketing
– Like: MOA, ADR, comparisons etc

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Drug Regulation in Oman: Ministry of Health
The Directorate General of Pharmaceutical Affairs and Drug Control

• Drug Procurement
— Oman is a member of the GCC states and WHO
— Saudi based SGH handles most procurement

• Drug Selection
— CDC is responsible for the selection of drugs for use by the public and
reports to the MOH

• Drug Manufacturing
— GMP is applied to industrial manufacturing
— Drugs are repackaged in a number of hospitals, clinics etc.

 Drug Prescribing: mainly 4 levels


—Over the counter products (OTC)
— Prescription only drugs
— Narcotics and psychotropics
— other controlled drugs
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