By students of Sir Dr. M S GOSAVI COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, Nashik The ppt will provide wide overview of career opportunities in pharmacy and basic knowledge of clinical research.

1. PHARMACEUTICAL ORGANIC CHEMISTRY
ACTIVITY- GROUP 11
TOPIC- S C O P E O F P H A R M A C Y A N D
C L I N I C A L R E S E A R C H

2. NAME OF STUDENT ROLL NUMBER
KUNAL PATIL 81
SAKSHI PATIL 82
SAKSHI PATIL 83
TEJAL PATIL 84
KHUSHI PATODKAR 86
HANSIKA PAWAR 87
MANSI PAWAR 88

3. PHARMACY IS….

4. PILLARS OF PHARMACEUTICAL SCIENCES

6. WHAT IS PHARMACEUTICAL
FORMULATION?

9. PHARMA INDUSTRY

12. SCOPE OF PHARMACY

13. FOLLOWING THE POSSIBLE SCOPE FOR
PHARMACISTS

18. WHAT IS CLINICAL RESEARCH ?
Systematic study of safety & efficacy of a new pharmaceutical
product (drug or device) when it is first time introduce into
humans.
• It includes the study of a
 New Drug
 New Disease
 New Technology

19. INTRODUCTION TO CLINICAL TRIALS
What are Clinical Trials?
Clinical trials are research studies that are conducted in
people (healthy participants or patients with a specific
health issue) in order to study and test new medical
treatments, such as drugs, vaccines, medical devices (e.g.
spinal cord stimulators), medical procedures (e.g. surgical
procedures), and diagnostic tests. Clinical trials may also
be conducted to study new combinations of treatments, or
to compare treatments, or to study an already available
treatment for a new use (e.g. to trial a drug currently used
for depression in patients with chronic pain).

20. IMPORTANCE OF RESEARCH
 New techniques for screening and diagnosing a disease.
 New drugs to market.
 New methods for surgery.
 New approach for radiation therapy.
 New combination of standard treatments.
 New techniques , such as gene therapy.

21. What Comes Before Clinical Trials?
Basic Research → Therapeutic Discovery → Preclinical
Research
Experiments performed in the laboratory are known
as “basic research”. The goal of basic medical
research is to increase our understanding of
normal human biology and diseases, and
ultimately to discover and develop new treatments
or technologies to improve health

22. Once the safety and potential effectiveness of the
treatment has passed preclinical studies and
been approved for human research, it will
undergo a series of carefully designed clinical
trials. Clinical trials are staged into “phases”. The
following table provides a summary of the phases
of clinical trials. Many clinical trials begin at Phase
1.

23. PHASE NATURE PARTICIPANTS PURPOSE (S)
0 Exploratory/Pilot
study
10-15 A small study(pilot) to
test how the human
body responds to a
very small
(sub-therapeutic)
dose of a drug.
To explore diagnostic
tests or study how
drugs or device work
(exploratory study)
I safety 20-100 The first stage of
testing effective
doses in human
(healthy humans
and/or patients) to
establish the safe,
therapeutic dose
range and identity any
side effects

24. PHASE NATURE PARTICIPANT
S
PURPOSE (S)
II Proof of concept 100’s To assess the
effectiveness of
the treatment
and further
investigate its
safety
III Regulatory Proof 100’s-1000’s To confirm the
clinical benefit
and safety risks
of the treatment
for the intended
health condition
To compare the
treatment,
usually
something
already on the
market, or to
non-
interventional
standard
care(e.g.

25. PHASE NATURE PARTICIPANT
S
PURPOSE (S)
IV Post –
market/surveillance
Large
populations
Marketing and
safety
surveillance of
the now
approved
treatment to
monitor its
effectivness,saf
ety and long-
term effects in
the general
population.
To compare the
approved
treatment to a
wide range of
established
treatments and
confirm where it
is best used

26. JOB OPPORTUNITIES IN CLINICAL RESEARCH