This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.

1. Scope Of Pharmacology
Dr.Ankita Jire
Jr 1
Dept of Pharmacology
GMC Nagpur
GUIDED BY
DR. V. M. Motghare
Professor & Head
Dept Of Pharmacology
DR. Chaitali Bajait
Assistant Professor
Dept Of Pharmacology

2. Overview
Introduction
Past-History
Materia medica
Pharmacy
Present-Academics
Research
Industries
Special Domains
 Future- Proteomics
Pharmacogenomics &
pharmacogenetics
Bioinformatics
Nanomedicine
Summary

3. Introduction
• Definition:
“Pharmacology- study of substances that interact
with living systems through chemical processes, by
binding to regulatory molecules and activating or
inhibiting normal body processes.”
SCOPE:
An area in which something
– Acts OR
– Operates OR
– Has power OR Control

4. Past.....
History
• Rudolph Bucheim
• 1st laboratory for drug research
• Investigation of drug is a task of
pharmacologist
• Oswald Schmiedeberg-
• Father of Modern Pharmacology
• 1st journal in Pharmacology

5. Materia medica
• Book contaning names of
herbs and medicine prepared fom it
• Dioscorides –Father of materia
medica
• Methods for purifying active
agents from crude materials were
absent hence real understanding of
mechanism of action was absent

6. Pharmacy
• Science and technique of preparing and dispencing drugs
• Includes collection,identification,purification,
isolation, synthesis, standerdization and quality control of
medicinal substances
• Pharmacology is an essential
component in the study of pharmacy

7. Present
Universe of Pharmacology
Special
Domains
Research
AcademicsIndustries

8. • Stages of drug development
Drug discovery phase
Preclinical phase
Clinical trial phase
Research

9. Drug discovery phase
1.Random screening
2.Serendipity (Happy observation ,by chance)
3.Rational drug designing
4.Designing of a prodrug or active metabolite as a drug

10. Preclinical/Experimental phase
• AIM- To satisfy all requirements that are needed
before a compound is considered fit to be tested in
human
• Require 1.5-2 yrs
• Out of 10,000 compounds screened only 10 qualify for
preclinical evaluation

11. • Deals with effect of various pharmacological agents
on different animal species
• Aims:
• Find out the therapeutic agent suitable for human use
• Study of toxicity of the drugs
• Study the mechanism and site of action of drugs

12. Done by –
1)In Vitro Study-Receptor characterization
Enzyme inhibition
Cytokine activity
2)In Vivo Study-Animal experiments

13. Clinical trial phase
Systematic study of new drug in human subjects
Phase 1-Healthy volunteers
(25-100) , Open label
Determines- safe dose
- pharmacokinetics
- any predictable toxicity
Phase 2-patient with target disease
Determine -efficacy
-definitive end point
A)Early phase 2- (200 patients)
Single blind

14. B)Late phase 2- (200-400 patients)
Double blind
Phase 3- (1000-5000+)
Large scale multicentre double blind
To further establish safty and efficacy
These 3 phses take 5-6 yrs
-New drug application for licensing
Phase 4- post licensing phase
No fixed duration
Periodic safety update report(PSUR) is to be
submitted

15. REVERSE PHARMACOLOGY
“Reverse pharmacology is the science of integrating
documented clinical/experimental hits, into leads by
transdisciplinary exploratory studies and further
developing these into drug candidates by
experimental and clinical research.”
• EXAMPLES OF REVERSE PHARMACOLOGY
Rauwolfia alkaloids in hypertension
Psoralens in vitiligo

16. Concept of reverse pharmacology
• It relates routine ‘Lab to clinic’ progress of discovery
to ‘Clinic to lab’.
• Conventional
molecule mice man
• Reverse pharmacology
man mice molecule
• In the process,
safty remains most important starting point and
efficacy becomes matter of validation

17. Academics
• Undergraduate education
-Introduction to drugs
-Mechanisms of actions
-Prescription writing
- Pharmaceutical preparations
-Identification of Adverse drug
reactions

18. • Postgraduate education
•Basic research
•Experimental pharmacology
•pharmacokinetics - dynamics
•Pharmacovigilance
•Clinical pharmacology
•Therapeutic drug monitoring

19. Term coined by Harry Gold in 1950s
Basic science of pharmacology: application of
pharmacological principles and methods in the real world
Makes pharmacology more attractive by bridging basic
science and clinical science
Platform for collaborative efforts between academia
and pharmaceutical industry.
Clinical Pharmacology

20. Frontiers of clinical
pharmacology
Clinical trials
BA/BE studies
Prescription audit
Antibiotic stewardship
Drug use survey
Rational use of medicines
TDM service

21. •BA/BE studies-
Bioavailability-Helps us deciding dose
Bioequivalent: Two drugs expected to be same for all
intents & purposes
•Prescription audit: To develop a list of essential drugs
Rational use of drugs
•Antibiotic stewardship
A set of coordinated strategies to improve the use
of antimicrobial medications
o enhancing patient health outcomes,
oreducing resistance to antibiotics,
o decreasing unnecessary costs.

22. •Drug use survey
Study of the marketing, distribution, prescription and
use of drugs in a society with special emphasis on the
resulting medical, social and economic consequences.“
•Rational Use Of Medicines
-Appropriate indication
-STEP Criteria i.e. Safety,Tolerability,Efficacy,Price
-Correct dispensing and appropriate instructions to
patient
-Adequate monitoring of patients adherence to the
treatment
-Watch for adverse effects of drugs

23. Therapeutic drug monitoring
• Concept of TDM is to individualise drug dosage to attain
certain target plasma concentration
• Uses:
1)Drugs with low margin of safty
EX.Digoxin,Theophylline, Antidepressants, Lithium
2)If individual variations are large
EX.Antidepressants, Lithium
3)In case of Poisoning
4)To check patient compliance
EX.Psychopharmacological agents

24. Clinical Pharmacology:
Making Its Heartbeats Felt
• By this time the busy clinicians have started
understanding the different approach of a clinical
pharmacologist in answering several drug and
therapeutics related questions.
• The need for generating local treatment guidelines had
long been realized by our fellow clinicians.
• The first such guideline, which was generated in the
institute by WHO ;For the management of community-
acquired pneumonia, clinical pharmacologists were
invited as a part of the team of experts

25. Industries
• Research: New Drug Development
• Medical advisor
• Medical transcription
• Medico marketing
• Product management
• Contract research organization
• Training

26. Medical Advisor
1.The analysis of the health of populations.
2. The evaluation of primary care services.
3. Planning of services.
4. Advice on effective prescribing
5.Education for general practitioners.
Medical transcription
The process of transcription or converting voice-
recorded reports as dictated by physicians and/or
other healthcare professionals, into text format.

27. Medico-marketing
• Business of advertising or otherwise promoting the
sale of pharmaceuticals or drugs
Contract research organization(CRO)
• A service organization that provides support to the
pharmaceutical and biotechnology industries in the
form of outsourced pharmaceutical research services
(for both drugs and medical devices).
• CROs specifically provide clinical-study and clinical-
trial support for drugs and/or medical devices.

28. Training
To medical representatives
To physicians
Academy for Clinical Excellence
(ACE)
Indian Society for Clinical
Research (ICSR)

29. Special Domains
• Pharmacovigilance
• Pharmacoeconomics
• Pharmacoepidemiology
• Chronopharmacology

30. Pharmacovigilance
•Pharmacovigilance
(Pharmakon-Drug; Vigilare-To keep watch)
•Definition (WHO) -
‘the science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other possible drug related problems’.
•Adverse drug reactions (ADRs) were 4th most common
cause of death in US in 1997

31. •The role of pharmacovigilance can be divided into
three main areas:
. To identify, quantify and document drug-related
problems
To contribute to reduce the risk of drug-related
problems in healthcare systems.
To increase knowledge and understanding of
factors and mechanisms which are responsible for
drug-related injuries

32. Pharmacovigilance Programme of
India (PvPI)
• WHO established its Programme for International Drug
Monitoring in response to the thalidomide disaster
detected in 1961.
• Uppsala andWHO together promotes Pharmacovigilance at
the country level.
• At the end of 2010, 134 countries were part of the WHO
Pharmacovigilance Programme.
• The programme is coordinated by The Indian
Pharmacopoeia Commission (IPC) located at Ghaziabad.

33. ADR reporting through Vigiflow
• Vigiflow is web based Individual Case Safty
Report(ICSR) management system that is specially
designed for use by national centres in the WHO
programme for International drug monitoring
• Vigiflow 5.1(Released on 14 june 2013)
• Subscription for vigiflow is free in India

35. Pharmacoeconomics
• Pharmacoeconomics 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 healthcare
results.
Involves two major methodologies
Cost Analysis Cost Outcome

36. Cost Analysis- Considers costs of providing healthcare
products or services
Cost Outcome-
Cost Minimization Analysis
Cost Effectiveness Analysis
Cost Benefit Analysis
Cost Utility Analysis

37. Pharmacoeconomic methods are used to assist
physicians, hospitals, insurers, patients and
healthcare professionals in making important
decisions as to what drug therapies should be chosen

38. •Pharmacoeconomics is used to determine which
drug should be included in the formulary by
choosing the most effective treatment at the lowest
price.
•It has been found that 86% of hospital
pharmacists indicate that pharmacoeconomic data is
used in formulary decision-making
•Pharmacoeconomic studies consider the total costs
incurred from the disease – both direct and indirect
costs

39. Pharmacoepidemiology
• Study of drugs among people
Pharmacon = Drugs
Epi = amongs
Demos = people
Logous = study
• Pharmacoepidemiology is study of use and effects of
drugs in large no. of persons

40. Pharmacoepidemiology is the application of epidemiologic
reasoning ,methods , and Knowledge to the study of uses
and effects of drugs in human population
Pharmaco
epidemiology
Epidemiology
Clinical
Pharmacology

41. •Pharmacoepidemiology Involves:
•Causality and incidence of ADRs
•Effectiveness of new drugs in defined population
•Pattern of prescribing in a particular health care
facility area
•Strategies to improve prescribing
•Economic impact of drug use

42. Chronopharmacology
• The study of how the effects of drugs vary with
biological timing and endogenous periodicities
• A method used in pharmacokinetics to describe the
diurnal changes in plasma drug concentrations.
Ex.
• H2 blockers should taken in evening or early night
when acid secretion is increasing

43. Glucocorticoids
• Major adverse effect — adrenocortical supression
• Significantly attenuated if correctly timed to
circadian rhythms.
• Best tolerated when ingested as a single daily dose in
the morning at start of the daily activity span
• Moderate dose in evening between dinner and
bedtime , risk of adrenocortical suppression is
heightened, even after a few days of treatment

44. Future….
• Proteomics
• Pharmacogenomics and pharmacogenetics
• Bioinformatics
• Nanomedicine

45. Proteomics
• Proteomics is the large-scale study of proteins,
particularly their structures and functions
• Proteomics is the study of the proteome—the
“PROTEin complement of the genOME
• Disease mechanism or drug effects both affect a
protein profile and, vice versa, characterising protein
profiles reveals information for the understanding of
disease and therapy.

46. Proteomics In Disease Treatment
• Many human diseases are caused by a normal protein
being modified improperly. This also can only be
detected in the proteome, not the genome.
• The targets of almost all medical drugs are proteins.
By identifying these proteins, proteomics aids the
progress in disease treatment.

47. Pharmacogenomics and
pharmacogenetics
• Pharmacogenomics is use of genetic information
to guide the choice of drug and dose ;on an
individual basis
• Analysis and comparison of the entire genome of
a single species or of multiple species
• A genome is the set of all genes possessed by an
organism
• Pharmacogenetics is study of genetic basis for
variability in drug response

48. Role of pharmacogenomics
 In new drug discovery
 In clincal trial
 Reintroduction of withdrawn or failure compound
 Identification of responder and nonresponder
 In maximizing efficacy
 In minimizing adverse drug reactions

51. Future of pharmacogenetics
• Genetic/genomic interindividual variability may lead to
genotype-specific development of new drugs
• Once adequate genotype/phenotype studies have
been conducted, molecular diagnostic tests will be
developed that detect >95% of the important genetic
variants for the majority of polymorphisms
• Genetic tests have the advantage that they need
only be conducted once during an individual’s lifetime.

52. Bioinformatics
• Bioinformatics is the unified discipline formed from
the combination of biology, computer science, and
information technology
• The mathematical, statistical and computing
methods that aim to solve biological problems using
DNA and amino acid sequences and related
information
• The primary goal of
bioinformatics is to
increase the understanding of
biological processes

53. Nanomedicine
• Nanomedicine is defined as the monitoring,repair,
construction and control human biological systems at
the molecular level using engineered nanodevices and
nanostructures
• Nanomedicine offers delivery of potential drugs which
were previously beyond reach of microscale drugs due to
specific biological barriers.

54. •Current applications of nanotechnology in medicine range
from research involving diagnostic devices and drug
delivery vehicles to robots that can enter the body and
perform specific tasks.
•Nanopharmacology- Drug design and drug delivery to
selected targets to improve pharmacodynamics and
kinetic profiles toward safer and effective treatment
•Nanomedicine offers delivery of potential drugs which
were previously beyond reach of microscale drugs due to
specific biological barriers.

55. Summary
• Pharmacology is backbone of medicine
• For rational use of drugs in day to day clinical practice
knowledge of pharmacology becomes essential
• It has wide scope in Research,Academics,Industries
which opens us doors for opportunities in career
development
• With technology development,it is going to be more
advanced in future for tretment of patients

56. References
• Kshirsagar N, Kumar V. Clinical pharmacology: Prospects and
development in India. Indian J Pharmacol 2011;43:489-91.
• Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug
reactions in hospitalized patients: a meta-analysis of prospective
studies. JAMA 1998;279:
1200-5.
• The importance of pharmacovigilance. Geneva: World Health
Organization; 2002.
• General pharmacology-Basic concepts(HL Sharma & KK
Sharma)2nd edition
• Basic And Clinical Pharmacology(Katzung)12th edition
• A report by,Dr Albert I Wertheimer and Nicole Chaney
Founding Director and Director of Research, Center for
Pharmaceutical Health Services Research,
Temple University

57. •Reverse Pharmacology And Registratiion Of Ayurvedic Drugs – by
Ashok D.B. Vaidya, Research Director, Kasturba Health Society, ICMR
Advanced Centre of Reverse Pharmacology.
•Robert Freitas, Nanomedicine 2, 1999, available at
http://www.foresight.org / Nanomedicine