GENERAL PRINCIPLES

of PHARMACOLOGY
[Faculty of Dentistry/ Class II] What is drug?
Sources of Drugs
Drugs Nomenclature
Routes of Administrations
Classification of Drugs
Branches of Pharmacology
New Drug Development
Drug Equivalences

Dr. Sema Ketenci

Istanbul Atlas University, Faculty of Medicine,
Medical Pharmacology Department
 What is Pharmacology ?
• PHARMACOLOGY:

Definition: Science of Drugs- Pharmakeia (Greek word for drugs) and logy (science)

Area of interest: Study of the interaction of drug-biological systems

Investigation:
• in vitro (on cell, tissue or organ)
• in vivo (experimental animals, humans)
• Ex vivo..

• The purpose of the investigations is to determine the most suitable chemical substance for the treatment,
diagnosis and prophylaxis.

• Treatment of diseases is the most important goal.

• If the treatment completely eliminates the cause of the disease, it is called 'radical treatment‘.
• if it can partially suppress it and makes the disease milder and slower, it is called 'palliative (symptomatic)
treatment'.
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Definitions about Pharmacology
• Pharmacology: Detailed study of drugs

• Pharmacognosy: Science of identification of drug

• Pharmacy: Science of identification, selection, preservation,

standardization, compounding and dispensing of medical substances

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 Definitions about Pharmacology
• Therapeutics: Branches of medicine concerned with cure of disease or relief of symptoms and includes
drug treatment

• Toxicology: Science of poisons. (Measurement/detections of poisons) also a branch of pharmacology.

• Pharmacy: Science of identification, selection, preservation, standardization, compounding and

dispensing of medical substances.

• Chemotherapy: Effect of drugs upon microorganisms and parasites, living and multiplaying in a living
organism.

• Phaemacopoeia: An official code containing a selected list of the established drugs and medicinal
preparations with description of their physical properties and tests for their identity, purity and potency.
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Definitions about Pharmacology

• Pharmaceutical form (dosage form): In order to apply to the patient, the active pure
substance or mixture is mixed with inactive excipients and special presentation forms
are created.

• Drug formulation: The selection of suitable excipients is made according to the specific
formulation.

• Medical preparation : It is a product that has been put into a special presentation form.
A medicine made by pharmaceutical companies and marketed with a special package
and name is called a 'medical preparation‘ or ‘pharmaceutical form’.

• World Health Organization (WHO) -Definition of drug: A drug is a substance or product

used to modify or study physiological systems or pathological conditions for the benefit
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of the recipient. Dr. Sema Ketenci 5
 DRUG

• A drug is a pure, biologically active chemical substance used in

medicine, or a mixture of plant and animal origin, containing a
standard amount of active substance.

• A drug can be defined as a chemical substance of known structure,

other than a nutrient or an essential dietary ingredient, which, when
administered to al living organism, produces a biological effect.

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 DRUG NOMENCLATURE
(Naming of Drugs)

• Generic (= generic, unclaimed) Name: Name

standardized by WHO, facilitating health
communication in the world, preventing mistakes
(Acetylsalicylic acid)

• Commercial (=preparation, brand, proprietary)

Name: Special name given by companies to their
own products (such as Aspirin, Ataspin, Dispril)

• Chemical Name: Name identifying the chemical

structure determined by the International Chemical
Society (2-acetyloxy benzoic acid)
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 SOURCES OF DRUGS
• A. Medicines of Natural Origin:

• Plants
• Animals (Obtaining hormones and enzymes - Bovine, liver extract)
• Microorganisms (Antibiotics: Penicillin G-Penicillium notatum)
• Minerals (minerals) (such as iodine, iron, sodium chloride,
magnesium salts, potassium chloride)

• B. Those produced by synthesis: Today, the number of drugs

produced by chemistry is much higher than drugs obtained from
natural sources.

• C. Those produced by DNA recombinant (gene cloning) method

(such as insulin, growth hormone)
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 From popy to morphine…

Lüllmann, Color Atlas of Pharmacology © 2000 Thieme

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 MAIN FEATURES OF DRUG EFFECT

Drug effect;
Must be!!!
• selective
• temporary
• dose dependent

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 MAIN FEATURES OF DRUG EFFECT

Drug effect;
• selective
• temporary
• dose dependent

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 MAIN FEATURES OF DRUG EFFECT

• Dose: It is the amount of drug given at

one time.

 When a drug is to be administered

the specific pharmacokinetic and
pharmacodynamic properties of the
drug should be considered.

• Daily dose: It is the total amount of

drug recommended to be given
throughout the day.
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 CLASSIFICATION OF DRUGS

• a. According to its chemical structure

(such as choline esters, organic phosphates, phenothiazine derivatives)

• b. According to the place of action

(such as autonomic nervous system drugs, central nervous system
drugs, heart drugs)
They are classified according to the place where they act in the
organism.

• c. According to the situation in which it is used (such as

antihypertensives, antipyretic drugs, antiemetic drugs, diuretics,
general anesthetics)

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 BRANCHES OF PHARMACOLOGY
• Pharmacokinetics: What describes the action of the body on the drug?

- absorption . : Absorption is the process by which a drug is transferred from its site of entry
into the body to the circulating fluids for distribution
- distribution : Distribution refers to the ways in which drugs are transported by the
circulating body fluids to the sites of action (receptors), metabolism, and
excretion.

- metabolism (biotransformation) : Biotransformation, also called metabolism, is the process

by which the body inactivates drugs.
- excretion

- bioavailability

• Pharmacodynamics: Term having to do with drug actions on the body:

• Examines the biochemical and physiological effects of drugs and their mechanism of action.
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 • Pharmacovigilance deals with the monitoring and
evaluation of marketed drugs for safety.

• Pharmacogenetics examines the genetic elucidation of

the therapeutic and toxicological response to drugs
and the investigation of the effects of inter-individual
genetic variability.

• Chemotherapy deals with microorganisms and

parasites that have settled in the patient's body and
examines what the drug does to the organism, not to
the body.
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 Clinical pharmacology aims to find
and develop new drugs.

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 Drug Development

• Studies on healthy subjects and seeks to determine

whether effects observed in animal experiments also
occur in humans.
• Dose-response relationships are determined.
• In Phase II, potential drugs are first tested on selected
patients for therapeutic efficacy in those disease states
for which they are intended.
• Should a beneficial action be evident and the incidence
of adverse effects be acceptably small, Phase III is
entered, involving a larger group of patients in whom
the new drug will be compared with standard
treatments in terms of therapeutic outcome. As a form
of human experimentation, these clinical trials are
subject to review and approval by institutional ethics
committees according to international codes of conduct
(Declarations of Helsinki, Tokyo, and Venice). During
clinical testing, many drugs are revealed to be
unusable. Ultimately, only one new drug remains from
approximately 10,000 newly synthesized substances.

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Lüllmann, Color Atlas of Pharmacology © 2000 Thieme
 NEW DRUG DEVELOPMENT
• a. Synthesis

• b. Preclinical Studies (screening tests) (Phase

0) The predicted effect, therapeutic index,
pharmacokinetic properties and toxicity are
investigated.
• - Culture
• - Isolated organs
• - Test animals

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 NEW DRUG DEVELOPMENT

c. Clinical Trials - Ministry of Health

General Directorate of Pharmaceuticals
and Pharmacy 'New research drug'

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 NEW DRUG DEVELOPMENT

• Phase 4: It covers the comparison studies of drugs

that are licensed and marketed and started to be
used by physicians with other drugs used in the
same indication in terms of clinical effectiveness,
cost-effectiveness and side effects.
• 4a.licensing
• 4b.Post Marketing Essays

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 Summary

• Phase 1:20- 80 healthy volunteers

By administering the drug in increasing doses, human tolerability,
drug safety, safe dose range, relations between human
pharmacokinetics and plasma level and pharmacodynamic effect
(Pharmacokinetic/Pharmacodynamic relationship) are
determined.
• Phase 2:Approximately 150-300 (limited) drug-targeted patients
with disease
The optimal dose of the drug, the therapeutic dose range, the
degree of therapeutic effect and the side effect profile are
determined.
• Phase 3:
• - Large number of patients and multicentre, multinational
• - It is done to evaluate the therapeutic effect of the drug by
comparing it with the standardized drug or placebo for that
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 DRUG EQUIVALENCES
• Pharmaceutical Equivalence:
Two different preparations contain the same molar
amount of the same active substance or substances in
pharmaceutical forms (such as tablets, capsules,
ampoules) conforming to the same or comparable
standards.

• Bioequivalence:
Two pharmaceutically equivalent preparations are so
similar that their bioavailability (with dimensions of rate
and degree of absorption) and thus their therapeutic
effect, after administration at the same molar dose, are
the same in terms of both efficacy and safety.

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 DRUG EQUIVALENCES

• Therapeutic Equivalence:
It is the case where a preparation
contains the same active substance as
another preparation whose efficacy and
safety have been previously
determined and clinically demonstrates
the same efficacy and safety.
It has no practical significance, it is
difficult to detect, bioequivalence is
usually taken as an indicator.

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 Learn About Clinical Studies
• How many phases are there in a drug study?
• four phases
• There are three phases to each clinical trial before it gets Food Drug
Administration (FDA) approval.
• What is a Phase 1 study?
• Phase I studies of a new drug are usually the first that involve
people. Phase I studies are done to find the highest dose of the new
treatment that can be given safely without causing severe side effects.

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 Learn About Clinical Studies
• What are the types of clinical trials?
• Types of clinical trials
• Pilot studies and feasibility studies.
• Prevention trials.
• Screening trials.
• Treatment trials.
• Multi-arm multi-stage (MAMS) trials.
• Cohort studies.
• Case control studies.
• Cross sectional studies.
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 Learn About Clinical Studies
• How long is a Phase 4 clinical trial?
• Since phase IV trials aim to study how a treatment will perform in the
long run, it shouldn't come as a surprise that they're quite long.
Typically they're conducted for a minimum of two years.
• Why do drugs fail in development?
• Lack of efficacy in the intended disease indication is the major cause
of clinical phase drug development failure. Explanations could include
the poor external validity of pre-clinical (cell, tissue, and animal)
models of human disease and the high false discovery rate (FDR) in
preclinical science.
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