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SCOPE OF PHARMACOLOGY
• According to history many scientist contributed to the concepts of pharmacology. Rudolf Buchheim (1820-1879) was
the originator pharmacology as an experimental science in 1847 in Germany
• Later on in 19th century
Father of Pharmacology- Oswald Schmiedeberg
Father of American Pharmacology- John Jacob Abel
Father of Indian Pharmacology- Colonel ram Nath Chopra
Father of clinical pharmacology- Loise Lasagna
• In 1805, Friedrich Serturner discovered morphine which has pharmacological activity as analgesic.
• Progressively with the passage of time various more drugs are introduced by the scientist which show specific
pharmacological effects
→ Greiger and Hassie(1833) – atropine
→ Vogt (1907) – histamine
→ P.Gleno (1908) – Sulfanilamide
→ Abel (1919) – Oxytocin
→ Banting and Best(1922) - Insulin
→ A.Flemming(1928) – Pencillins
→ Domagk (1932) – Sulfonamide
→ Edward C. Kendall – Cortisone
→ Waksman (1944) – streptomycin
→ Bartz (1948) – Chloremphenicol
→ Duggar (1948) – tetracyclin
→ Cade (1950)- Lithium
❖ SCOPE-
• An area in which something
− Act or
− Operates or
− has power or control
• Main areas are-
A. Research
B. Academics
C. Clinical pharmacology
D. Industries
E. Pharmacovigilance
F. Pharmacoeconomics
G. chronopharmacology
A. Research -It can be divided into two category
a) Forward approach or classical approach and
b) Reverse pharmacology or target based screening
a) Forward approach or classical approach- there are three stages of drug development
1) Drug discovery
i) Random screening
ii) Serendipity(संयोगवश कुछ अच्छा मिल जाना)
iii) Rational drug designing
iv) Designing of prodrug or active metabolite as drug
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2) Preclinical phase/experimental phase
• To satisfy all requirements that are needed before a compound is considered fit to be tested in
humans
• Require 1-2 year
• Out of 10,000 compounds screened only 10 qualify for preclinical evaluation
• Deals with effect of various pharmacological agents on different animal species
➢ Aim
• Find out therapeutic agent suitable for human use
• Study of toxicity of the drugs
• Study the mechanism and site of action of drugs
➢ Done by
• In vitro study- receptor characterisation, enzyme inhibition, cytokine activity
• In vivo study- Animal experiments
3) Clinical trial phase- in this systematic study of new drug in human subjects
• Phase-1- in this phase subjects Healthy Volunteers (25-100) to determine the safe dose,
pharmacokinetic and any predictable toxicity
• Phase-2- in this phase subjects are patient with target disease to determine the efficacy and definitive
end point(how patients feel, function and survive)
• Early phase-2 In this subject increase to 200 patient with single blind(A type of clinical trial in which
only the researcher doing the study knows which treatment the participant is receiving until the trial
is over.)
• Late phase 2- in this subject increase to 200-200 patient with double blind(A type of clinical trial in
which neither the participants nor the researcher knows which treatment participants are receiving
until the clinical trial is over.)
• Phase-3- in this phase subjects increase to 1000-5000+ to further establish safety and efficacy
These 3 phase take 5-6 years
• Filling of New drug application
• Phase-4 – this is a post licensing phase and has no fixed duration. In this phase periodic safety
report(PSUR) is to be submitted
b) Reverse pharmacology or target-based screening-
• Reverse pharmacology (target-based screening) began with the growth of molecular biology
•
It starts with the identification of a molecular target (protein; enzyme, receptor, etc.) that is involved in
the pathophysiology of a disorder or disease
•
Then potential ligands (compounds) are screened through binding assay where the highly selective ligand
that binds with the molecular target is identified. This is a process known as 'ligand fishing'.
• Then this potential ligand (compound) undergoes functional studies (animal models) to show the desired
physiological effect.
• Once experimental results are consistently significant, clinical studies can began.
• Reverse pharmacology speed up the process, provide clear understanding of the mechanism of action,
optimize safety as well as increase efficiency (highly selective and potent) of the drug.
B. ACADEMICS
i) Undergraduate education
• Introduction to drugs
• Mechanisms of action
• Prescription writing
• Pharmaceutical preparation
• Identification of adverse drug reaction
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ii) Post graduate education
• Basic research
• Experimental pharmacology
• Pharmacokinetics and pharmacodynamics
• Pharmacovigilance
• Clinical pharmacology
• Therapeutic drug monitoring
C. CLINICAL PHARMACOLOGY
• Term coined by Harry Gold in 1950s
• It uses basic science of pharmacology and apply pharmacological principles and method in the real world
• It connect basic science and clinical science
• It is a platform for collaborative efforts between academia and pharmaceutical industry.
• Frontiers of clinical pharmacology are
i) Clinical trails
ii) BA/BE studies
• BA(Bioavailability)- BA studies help in deciding the dose of drugs
• BE(Bioequivalent)- when two drugs expected to be same for all intents and purposes
iii) Prescription audit- To develop a list of essential drugs
iv) Antibiotic stewardship- to improve the use of antimicrobial medications to
→ Enhance patient health outcomes
→ Reducing resistance to antibiotics
→ Decreasing unnecessary cost
v) Drug use survey
• Study of the marketing, distribution, prescription and use of drugs in a society with special
emphasis on the result of medical, social and economic consequences
vi) Rational use of medicine
• Appropriate medication
• To check safety, tolerability efficacy and price (STEP criteria)
• Correct dispensing and appropriate instruction to patient
• Adequate monitoring of patient adherence to the treatment
• Watch for adverse effect of drug
vii) Therapeutic drug monitoring (TDM) service- it is testing that measures the amount of certain
medicines in your blood. It is done to make sure the amount of medicine you are taking is both safe
and effective.
D. INDUSTRIES
i) Research: New drug development
ii) Medical advisor
• Analysis of health of population
• Evaluation of primary care service
• Planning of services
• Advice on effective prescribing
• Education for general practitioner
iii) Medical transcription
• The process of transcription or converting voice-recorded reports as directed by physician or other
healthcare professional into text format
iv) Medico marketing
• Business of adverting or promoting sale of pharmaceutical or drugs
v) Product management
vi) Contract research organisation
• A service organisation that provides support to the pharmaceutical and biotechnology industries in
the form of outsourced pharmaceutical research services, for both drugs and medical devices.
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vii) Training
• To medical representatives
• To physician
• Academy for clinical excellence (ACE)- The Academy for Clinical Excellence (ACE) is the pioneering
clinical research training institute in India established in February 2002
• Indian society for clinical research (ISCR)
E. PHARMACOVIGILANCE (Pharmakon- Drug, Vigilare- To keep Watch)
• Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other medicine/vaccine related problem.
• The role of pharmacovigilance can be divided into three main areas
i) To identify, quantify and document drug related problem
ii) To contribute to reduce the risk of drug related problem in health care system
iii) To increase knowledge and understanding of factors and mechanisms which are responsible for drug-
related injuries.
F. PHARMACOECONOMICS
• It is a branch of health economics which particularly focuses upon the costs and benefits of drug therapy
• It is an innovative method that aims to decrease health expenditures while optimising health care results
• It involves two major methodologies- i) Cost analysis and ii) Cost outcome
• Pharmacoeconomics is used to determine which drug should be included in the formulary by choosing the
most effective treatment at the lowest price.
G. PHARMACOEPIDEMIOLOGY
• It is the study of drugs among people
Pharmakon = Drugs
Epi = among
Demos = people
Logous = study
• It is study of use and effect of drugs in large number of people
• It involves-
i) Casuality and incidence of adverse drug reactions
ii) Effectiveness of new drugs in defined population
iii) Pattern of prescribing in a particular health care facility area
iv) Strategy to improve prescribing
v) Economic impact of drug use
H. CHRONOPHARMACOLOGY
• Chronopharmacology is the science dealing with the optimization of drug effects, and the minimization of
adverse effects by timing medication in relation to the biological rhythm
• EX- Evening dosing has become standard for H2 receptor antagonists, because available agents inhibit
nocturnal basal acid secretion more effectively than daytime stimulated secretion