Pharmacology: Introduction to pharmacology

CONTENTS
Introduction
Scope
History
Pharmacokinetics
Pharmacodynamics
Drug
Route of administration
Adverse reactions
Regulation and approval of Drug
Ethical & legal Considerations
How Allopathy is Different from Other Medical Practices
Emerging Trends in Pharmacology

1. PHARMA
COLOGY
Presented By : H.hoda
Jaipur National University | 2024
Bsc. (OT Technologist)

2. OVERVIEW
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Introduction
Scope
History
Pharmacokinetics
Pharmacodynamics
Drug
Route of administration
Adverse reactions
Regulation and approval of Drug
Ethical & legal Considerations
How Allopathy is Different from Other Medical Practices
Emerging Trends in Pharmacology

3. INTRODUCTION
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Pharmacology is the branch of medicine and
biology that focuses on the study of drugs and
their effects on living organisms. It involves
understanding how drugs interact with the
body, how they are absorbed, distributed,
metabolized, and excreted, as well as their
therapeutic and adverse effects.
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4. SCOPE
Study of the biochemical and
physiological effects of drugs and
their mechanisms of action.
Pharmacodynamics
Study of the absorption,
distribution, metabolism, and
excretion (ADME) of drugs.
Pharmacokinetics
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Application of pharmacological
principles and methods in the
medical clinic and patient care.
Clinical Pharmacology
Study of the adverse effects of
chemicals, including drugs, on
living organisms.
Toxicology
Study of drug design, synthesis,
and chemical properties.
Pharmaceutical Chemistry
Science and activities relating to
the detection, assessment,
understanding, and prevention of
adverse effects or any other drug-
related problems.
Pharmacovigilance
Study of the medicinal use of
plants and other substances by
indigenous cultures.
Ethnopharmacology
Involves the regulation and
approval processes for new drugs
by governmental bodies.
Regulatory Pharmacology

5. HISTORY
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Early Use of Medicinal Plants: Ancient civilizations like the Egyptians, Greeks, Chinese, and Indians used plants for healing purposes. For
example, the Ebers Papyrus (circa 1550 BCE)
Traditional Chinese Medicine: The "Shennong Ben Cao Jing" (circa 200 CE) is one of the earliest Chinese texts on herbal medicine.
Ayurveda in India: Ancient Indian texts such as the "Charaka Samhita" (circa 1000 BCE) describe various medicinal plants and
treatments.
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Ancient Beginnings
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Hippocrates (460-370 BCE): Known as the "Father of Medicine," he emphasized the use of natural substances for healing.
Galen (130-200 CE): His work combined knowledge from previous cultures and remained influential for many centuries. He promoted
the idea of balancing bodily humors through medication.
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Foundations in Greece and Rome
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6. HISTORY
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Islamic Golden Age: Scholars like Avicenna (980-1037 CE) wrote "The Canon of Medicine," which integrated Greco-Roman knowledge
with Islamic medical practices and introduced many new medicinal compounds.
Alchemy and Early Chemistry: Alchemists in medieval Europe and the Islamic world laid the groundwork for modern chemistry and
pharmacology, seeking the "elixir of life" and cures for diseases.
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Middle Ages and Renaissance
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Islamic Golden Age: Scholars like Avicenna (980-1037 CE) wrote "The Canon of Medicine," which integrated Greco-Roman knowledge
with Islamic medical practices and introduced many new medicinal compounds.
Alchemy and Early Chemistry: Alchemists in medieval Europe and the Islamic world laid the groundwork for modern chemistry and
pharmacology, seeking the "elixir of life" and cures for diseases.
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Middle Ages and Renaissance
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7. HISTORY
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Drug Discovery and Development: The 20th century saw rapid advancements in drug discovery, including antibiotics like penicillin, and
the development of vaccines.
Molecular Pharmacology: Advances in molecular biology and genetics have transformed pharmacology, leading to targeted therapies
and personalized medicine.
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20th Century to Present
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Biopharmaceuticals: The development of biotechnology has led to the creation of biologics, such as monoclonal antibodies and gene
therapies.
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Isolation of Active Compounds: Advances in chemistry allowed scientists to isolate active compounds from plants, such as morphine
from opium and quinine from cinchona bark.
Establishment of Pharmacology as a Science: Rudolf Buchheim (1820-1879) is considered one of the founders of pharmacology. He
established the first pharmacology laboratory at the University of Dorpat (now Tartu, Estonia).
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19th Century: The Birth of Modern Pharmacology
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Claude Bernard (1813-1878): A French physiologist, he made significant contributions to understanding the mechanisms of drug action.
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8. PHARMACOKINETICS
Pharmacokinetics is a fundamental aspect of
pharmacology that involves the study of how drugs
move through the body over time. It encompasses
the processes of absorption, distribution,
metabolism, and excretion (ADME). Understanding
pharmacokinetics is crucial for determining the
appropriate dosage, frequency, and duration of
treatment to ensure therapeutic effectiveness
while minimizing toxicity.
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9. PHARMACOKINETICS
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The process by which a drug is transferred from the site of administration into the systemic
circulation. Determining how a drug enters the bloodstream from its site of administration. The
efficiency and rate of absorption impact the onset, intensity, and duration of a drug's therapeutic
effect.
Absorption
After a drug is absorbed, it is then distributed throughout the body. Distribution describes the
process of a drug traveling into different organs and tissues and depends on a multitude of factors
including fluid status, blood flow, and chemical characteristics of the drug. Distribution is
measured by a fundamental PK parameter known as the volume of distribution.
Distribution

10. PHARMACOKINETICS
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Drug metabolism is the process of chemically altering the molecules of a drug, which creates new
compounds. The compounds created from this process are known as metabolites. Metabolism
may occur in many areas of the body including the gastrointestinal tract, kidneys, and plasma, but
the majority of metabolism occurs in the body’s largest internal organ, the liver.
Metabolism
Any drug that is not eliminated from the body via metabolism is eliminated via excretion. Although
drugs can be excreted by a variety of different routes including the liver, lungs, gastrointestinal
tract, and skin, the most common pathway of excretion is through the kidneys.
Excretion

11. PHARMACOKINETICS
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Key Parameters in Pharmacokinetics
Half-Life (t½): The time required for the plasma concentration of a drug to reduce by
half. It helps determine dosing frequency.
Clearance (Cl): The volume of plasma from which the drug is completely removed per
unit time. It reflects the efficiency of drug elimination.
Bioavailability (F): The fraction of the administered dose that reaches systemic
circulation in an active form.
Volume of Distribution (Vd): Indicates how extensively a drug distributes into body
tissues relative to the plasma.

12. PHARMACODYNAMICS
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Pharmacodynamics is the study of the biochemical and physiological effects
of drugs on the body and the mechanisms of their actions, including the
relationships between drug concentration and effect. While
pharmacokinetics focuses on how the body affects a drug,
pharmacodynamics focuses on how the drug affects the body.

13. PHARMACOKINETICS
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Key Parameters in Pharmacokinetics
1. Drug-Receptor Interaction:
Receptors: Proteins or glycoproteins on cell surfaces or within cells that drugs bind to
exert their effects. Receptors can be enzymes, ion channels, transport proteins, or
nuclear receptors.
Ligands: Molecules that bind to receptors. Drugs can act as ligands, mimicking or
blocking the action of endogenous substances.

14. PHARMACOKINETICS
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Key Parameters in Pharmacokinetics
2. Types of Drug Actions:
Agonists: Drugs that bind to and activate receptors, mimicking the effect of
endogenous ligands (e.g., morphine activates opioid receptors to reduce pain).
Antagonists: Drugs that bind to receptors but do not activate them, blocking the
action of endogenous ligands or agonists (e.g., naloxone blocks opioid receptors,
reversing opioid effects).
Partial Agonists: Drugs that activate receptors but produce a weaker effect than full
agonists (e.g., buprenorphine for opioid dependence).
Inverse Agonists: Drugs that bind to receptors and induce the opposite effect of
agonists.

15. PHARMACOKINETICS
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Key Parameters in Pharmacokinetics
3. Mechanisms of Drug Action:
Enzyme Inhibition or Activation: Drugs can inhibit or activate enzymes, altering the
biochemical pathways (e.g., aspirin inhibits COX enzymes, reducing inflammation).
Ion Channel Modulation: Drugs can open or close ion channels, affecting cell
membrane potential and cellular activity (e.g., calcium channel blockers reduce heart
rate).
Transporter Modulation: Drugs can inhibit or enhance the function of transport
proteins, affecting the movement of substances across cell membranes (e.g., SSRIs
inhibit serotonin reuptake, increasing serotonin levels).

16. DRUG
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Drugs are chemical substances used to prevent, diagnose, treat, or cure diseases. They can
affect the body in various ways depending on their chemical composition, mechanism of
action, and the condition being treated. a drug typically consists of two main
components: the Active Pharmaceutical Ingredient (API) and the Excipients (inactive
ingredients).
API ExcipientsDrug

17. DRUG
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Active Pharmaceutical Ingredient (API)
The Active Pharmaceutical Ingredient (API) is the part of the drug that produces the
intended therapeutic effect. It is the biologically active component responsible for the
drug’s efficacy in treating a condition. Example: Ibuprofen (Analgesic (pain reliever) and
anti-inflammatory)
Excipients
Excipients are the inactive components of a drug formulation. They do not produce any
direct therapeutic effect but are essential for the drug’s overall performance, stability,
and administration.

18. DRUG
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Roles of Excipients:
Binders: (Microcrystalline cellulose)
Fillers: (Lactose, mannitol)
Disintegrants: (Croscarmellose sodium, starch)
Lubricants (Magnesium stearate)
Preservatives: (Benzalkonium chloride)
Flavoring Agents: (Saccharin, fruit flavors)
Coloring Agents: (FD&C Red No. 40, titanium dioxide)
Coating Agents: (Hydroxypropyl methylcellulose (HPMC)
Solvents: (Water, ethanol)

19. ROUTES OF ADMINISTRATION
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Routes of drug administration refer to the various paths by which a drug can be introduced into the
body to achieve its therapeutic effect. These routes determine the location where the drug is
administered and how it reaches the site of action. The choice of route affects the drug's absorption,
distribution, metabolism, and excretion, ultimately influencing its efficacy and safety. The route of a
drug can be determined on the basis of drug nature, patient’s condition, severity of disease and it
can classify into types:
Systemic: Delivers the drug into the bloodstream for widespread distribution throughout the
body. This includes enteral and parenteral.
Local: Delivers the drug directly to the site of action, minimizing systemic exposure and reducing
the risk of systemic side effects. Examples include topical, ophthalmic, otic, and some inhalation
routes.

20. ROUTES OF ADMINISTRATION
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Enteral
Enteral Routes: involve the gastrointestinal tract, and the drug must pass through the digestive
system before reaching the bloodstream (e.g., oral, sublingual, buccal, rectal)
Parenteral Routes: bypass the gastrointestinal tract entirely, allowing the drug to enter the systemic
circulation more directly (e.g., IV, IM, SC) routes
Oral
Sublingual
Rectal
Inhalational
Transdermal
Injections
Skin Topical
Intranasal
Ocular Drops
Mucosal Throat
(vaginal, mouth,
ear)
Systemic Local
Parenteral

21. ADVERSE EFFECT
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Adverse effects (also known as adverse drug reactions or side effects) are unintended, harmful
effects that occur when a drug is administered at normal doses for therapeutic purposes. These
effects can range from mild to severe and can impact patient compliance and overall treatment
outcomes. Adverse effects can range from mild discomfort to severe health complications and can
vary from person to person.
Augmented (Dose-Related) Predictable
Bizarre (Non-dose related) Unpredictable
Chronic (Dose-Related and Time-Related)
Delayed (Time-Related)
End of Treatment (Withdrawal)
types

22. REGULATION AND APPROVAL
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The regulation and approval of drugs are crucial processes that ensure the safety, efficacy, and
quality of pharmaceuticals before they reach the market. This process involves rigorous testing,
review, and monitoring by various regulatory agencies worldwide.
Drug Development Process
The drug development process consists of several key stages
Discovery and Preclinical Research:
Discovery: Identifying potential drug candidates through various methods, including high-
throughput screening, biotechnology, and computer-aided drug design.
Preclinical Testing: Conducting laboratory and animal studies to evaluate the safety, efficacy, and
pharmacokinetics of the drug. This stage helps determine whether the drug is safe enough to be
tested in humans.

23. REGULATION AND APPROVAL
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Drug Development Process
Investigational New Drug (IND) Application:
Before starting clinical trials, a company must submit an IND application to the relevant
regulatory agency (e.g., CDSCO in the INDIA, FDA in the U.S.). The application includes data from
preclinical studies, proposed clinical trial protocols, and manufacturing information.
Clinical Trials: Clinical trials are conducted in several phases to assess the drug's safety, efficacy, and
optimal dosing.
Phase I:
Objective: Assess safety, dosage range, and pharmacokinetics in a small group of healthy
volunteers (20-100 participants).
Focus: Identify side effects and establish a safe dosage range.

24. REGULATION AND APPROVAL
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Drug Development Process
Clinical Trials:
Phase II:
Objective: Evaluate the drug's efficacy and further assess its safety in a larger group of patients
(100-300 participants) with the target condition.
Focus: Determine the optimal dose and gather preliminary data on effectiveness.
Phase III:
Objective: Confirm the drug's efficacy and monitor adverse reactions in a larger population
(1,000-3,000 participants).
Focus: Provide comprehensive data on safety and effectiveness to support regulatory approval.

25. REGULATION AND APPROVAL
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Drug Development Process
Clinical Trials:
Phase IV (Post-Marketing Surveillance):
Objective: Monitor the drug's performance in the general population and identify any long-term
or rare side effects.
Focus: Ensure ongoing safety and effectiveness after the drug is marketed.
New Drug Application (NDA) / Marketing Authorization Application (MAA):
After successful completion of clinical trials, the company submits an NDA to the CDSCO or FDA.
This application includes all data from clinical trials, preclinical studies, proposed labeling, and
manufacturing information.

26. REGULATION AND APPROVAL
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Drug Development Process
Regulatory Review and Approval:
The regulatory agency reviews the application to ensure the drug's safety, efficacy, and quality.
This process may involve advisory committees and public hearings.
If approved, the drug is granted marketing authorization, allowing it to be sold and prescribed.
Regulatory Agencies
Food and Drug Administration (FDA): in US
European Medicines Agency (EMA): in European Union
Central Drugs Standard Control Organisation(CDSCO): under Directorate General of Health Services,
Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA)
of India.

27. LEGAL CONSIDERATIONS
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Drug Development Process
The development, testing, prescribing, and dispensing of drugs involve a complex web of ethical and
legal considerations. Ensuring the protection of human subjects, maintaining fairness and
transparency in clinical trials, and adhering to legal standards for prescribing and dispensing drugs
are all critical components of the healthcare landscape.
Legal Aspects of Prescribing Drugs
Regulations and Licensing: Legal requirements that Physicians, pharmacists, and other healthcare
providers must be properly licensed and adhere to the regulations set by relevant authorities.

28. LEGAL CONSIDERATIONS
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Legal Aspects of Prescribing Drugs
Controlled Substances: Strict regulations govern the prescribing, dispensing, and record-keeping
of controlled substances to prevent misuse and diversion.
Adverse Drug Reactions (ADRs) Reporting: Mandatory reporting helps monitor drug safety and
can lead to regulatory actions if a drug poses significant risks.
Pharmacovigilance: Regulatory agencies require pharmaceutical companies to continuously
monitor and report on the safety of their drugs, taking necessary actions if new risks are
identified.

29. HOW ALLOPATHY IS DIFFERENT FROM
OTHER MEDICAL PRACTICES
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Several medicinal practices have developed over time, such as Unani in the Arab world, Ayurveda in
India, Traditional Chinese Medicine, and various tribal medicinal practices. Unlike these traditional
methods, which often relied on trial and error, Allopathy is based on evidence.
To illustrate this, consider the example of the Cinchona tree in South America during the 1600s.
People discovered that giving extracts from the Cinchona tree to patients with fever helped cure
them, even though they did not understand the underlying molecular or cellular mechanisms. Before
this discovery, many treatments were attempted randomly with no scientific basis.

30. HOW ALLOPATHY IS DIFFERENT FROM
OTHER MEDICAL PRACTICES
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Then, in the 1820s, a French scientist successfully extracted quinine from
the Cinchona tree. Today, quinine is recognized and used as an anti-
malarial medicine. This transition from trial-based practices to
evidence-based medicine highlights the development and importance
of allopathic medicine.

31. EMERGING TRENDS IN
PHARMACOLOGY
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Precision Medicine
Biologics and Biosimilars
Individualized Treatments: Customizes medications based on a patient’s genetic, environmental,
and lifestyle factors for more effective and safer therapies.
Advanced Therapies: Utilizes complex biological drugs and their affordable counterparts
(biosimilars) to treat diseases with greater specificity and efficacy.

32. EMERGING TRENDS IN
PHARMACOLOGY
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AI and Machine Learning
Nanotechnology in Drug Delivery
Smart Drug Development: Uses AI and machine learning to accelerate drug discovery, optimize
clinical decisions, and analyze large datasets for new insights.
Targeted Delivery: Develops nanoparticles to deliver drugs precisely to diseased cells, enhancing
efficacy and reducing side effects.

33. THANK YOU
Presented By : H.hoda
Jaipur National University | 2024
Bsc. (OT Technologist)