Page 1

General in Pharmacology
Definitions
Dr. Lecturer Merve Submarine
27.10.2020
Page 2

➢ Pharmacology
➢ in vitro
➢ in vivo
➢ in silico
Page 3

Branches of Pharmacology
➢ Pharmacokinetics
➢ Pharmacodynamics
➢ Toxicology
➢ Chemotherapy
➢ Clinical pharmacology
➢ molecular pharmacology
➢ Biochemical pharmacology
Page 4

Basic Concepts of Drugs

According to the World Health Organization (WHO);
Medicine: Physiological conditions or pathological events, for the benefit of the field
As a substance or product used to change, examine
is defined.
Dosage: It is the amount of medicine given at one time.
Daily dose: It is the recommended amount of medication to be given throughout the day.
Side effects: Even with the usual doses of drugs, the desired effects
In addition, they have unwanted effects.
Toxic effect: Generally aggravation of pharmacodynamic effects of drugs.
uncomfortable for the dependent patient and in some cases can cause death
is the effect.
Confidence interval: The difference between the therapeutic dose and the toxic dose of the
drug
called range.
Page 5

Basic Concepts of Drugs

According to the World Health Organization (WHO);
Indication: The drug is called the states that should not be used.
Contraindication: The drug should not be used.
Resistance: Depending on the properties of microorganisms, drugs
development of resistance and ineffectiveness of drugs.
Tolerance: When drugs are used continuously, the effect normally taken
It is a gradually decreasing condition.
Drug half-life: The concentration of a drug in plasma
It is the time it takes to cut in half.
Page 6

Basic Concepts of Drugs

According to the World Health Organization (WHO);
Teratogenic effect: Some substances can be used by pregnant women
When they are removed, they pass through the placenta to the fetal circulation and
causes malfunctions. Teratogenesis or fetotoxic
called effect.
Mutagenic effect: Occurring for various reasons and cell
They are permanent changes in their DNA. Mutagen; cause mutation
is the active substance.
Carcinogenic effect: The cells in the body, sufficient
without differentiation, uncontrolled and quickly
The condition manifested by its division is called cancer (carcinoma).
All substances that make up cancer are called carcinogens.
Page 7

''World Health Organization''

MEDICINE
Physiological systems or pathological
changing situations for the benefit of the field
or used for review or
a substance or
product.
Page 8

Sources of Drugs
➢ Natural resources
- plants
- animals
- microorganisms
- minerals
➢ Chemical synthesis
Page 9

DNA Recombination Technology

➢ Synthesizing the active substance in its ribosomes
from cells, this synthesis through mRNAs
removing the controlling gene
➢ DNA chain of vectors such as virus, plasmid
assemble
➢ A fast-reproducing vector like E. coli
insert into microorganism - Gene
cloning
''  Recombinant Biotechnology Product Pharmaceutical ''
'' Biopharmaceuticals ''
Page 10

➢ Radical Treatment
➢ Symptomatic (Palliative) Treatment
➢ Prophylactic (Protective) Treatment
Page 11

Basic Features of Drug Effect

➢ Selectivity
➢ The effect is temporary
➢ Dose dependent
Page 12
Classification of Drugs
➢ Chemical structure
➢ Place of influence
➢ Clinical situation used, intended use
Page 13

Names of Drugs
➢ Common name (Generic name)
➢ Owned name (Commercial name, Prepared name)
➢ Chemical name
Page 14

NEW DRUG DEVELOPMENT

Of a mold fungus ( Penicillium notatum)
Lethal effect against staphylococci
Observation by Fleming in 1929
↓
With the invention of penicillin in the late 1930s
opening the age of antibiotics
↓
The modern era of drug development and treatment
initiated.
Page 15

NEW DRUG DEVELOPMENT

Pre-clinical Reviews:
Thousands of new substances are synthesized,
Material is produced from natural resources,
Recombinant products are created,
↓
SCAN TESTS
Basis matching the predicted therapeutic effect of the drug developed
demonstrating its effects or toxicity
in vitro test systems
in vivo animal models
Page 16

NEW DRUG DEVELOPMENT

Clinical Trial Periods:
Goal;
➢ To prove its effectiveness
➢ To determine the safety
➢ To show your superiority over current drugs
Page 17

➢ Testing new drugs in humans requires strict ethical and scientific

It depends on the rules and legal provisions.
➢ Ethical committees and official drug regulatory authority
need approval.
➢ Providing verbal and written information to the subjects and in the
presence of the witness.
informed written consent is required.
➢ After the new investigational drug is approved, clinical trials
phase I begins; phase II and phase III trials follow.
Page 18

First Term (Phase I) Trials

➢ Up to 20-80, depending on the type of drug,
usually done in healthy subjects (subjects).
➢ The first stage is the first dose to be given to a human.
is determination.
➢ By giving the drug in increasing doses, human
research
the tolerability / tolerance of the drug
safe dose range and human pharmacokinetics
is determined.
Page 19

Second Term (Phase II) Trials

➢ Efficacy and safety is the review period.
➢ Having the disease for which the drug was developed
It is performed in a limited number of patients (150-300).
- Phase IIa: the optimal dose of the drug in patients and
therapeutic dose range
- Phase IIb: degree of therapeutic effect and
side effect profile is determined.
Page 20

Third Period (Phase III) Trials

➢ Comparative treatment and safety review
period.
➢ In many (2-3 thousand) patients, multi-center and
even multinational studies.
➢ Therapeutic efficacy and benefit / harm ratio, same
another medicine being used in the disease or
evaluated against placebo.
Page 21

Phase III periods;

- Phase IIIa: for authorization from the start of Phase III
The time until the application to the official institution
- Phase IIIb: Time from application to marketing
➢ Registration and marketing application
from the moment the drug is approved and marketed
Phase IV studies are started.
Page 22
Fourth Term (Phase IV) Trials
(post-marketing surveillance studies)
➢ Routine medical treatment of the licensed and
marketed drug
in terms of safety under conditions of use
monitoring studies.
➢ Drug clinical efficacy, side effect profile and
in the same indication in terms of pharmacoeconomics
compared with other drugs used.
Page 23

➢ Time from synthesis to licensing

Not less than 5 years. 10-12 years on average
is considered normal. 250-500 million dollars
requires expense.
➢ Deadly diseases such as AIDS, cancer
Drugs with potential for treatment shorter
after clinical trials
accelerated
They may be subject to licensing.