Name :

Ayush Kariya
19bph015
Darsh Karia 19bph020
Sagar Panchal
19bph092
Shiv Patel 19bph097
Sneha Gorania
Domain: Clinical Research and Pharmacy Practice
19bph101
Vivek Odedra
Guided by: Dr. Snehal Patel
19bph118
Dr. Shital Panchal
Dr. Jigna Shah
Dr. Bhagwati Saxena
Dr. Richa Gupta
Introduction to Drug Discovery
Visit to Cell Culture Lab
Targets for Drug Action

► Disease-to-target discovery is the process of identification and

early validation of targets involved in a disease. By exploring the
pathophysiological map of a disease, we help our clients identify
proteins than can become targets for the development of new
compounds.

► Target identification can be approached by direct biochemical

methods, genetic interactions or computational inference. In many
cases, however, combinations of approaches may be required to
fully characterize on-target and off-target effects and to
understand mechanisms of small-molecule action.
Targets for Diabetes
 Pre-Clinical Trials
• In drug development, preclinical development is a
stage of research that begins before clinical trials
(testing in humans) in laboratory animals.
• The main goals of pre-clinical studies are to determine
a product's ultimate safety profile.
IMPORTANCE -• To determine the dose, toxic dose, pharmacological
action, etc.
• It is the requirement of regulatory body for
performingclinicaltt
• As ethical view point, it is necessary to check safety of
drug on animals before starting to check on human being.
To check the kinetic profile of drug & based on it, select
the route of administration in human for clinical trials.
THERE ARE SEVERAL STEPS INVOLVED WITH DOING A 8
PRE- CLINICAL TRIAL:
1. Indentify a Drug Target
2. Develop a Bioassay
3. Screen the Drug in the Assay
4. Establish Effective and Toxic Doses
5. File for approval as an Investigational New Drug (IND)
CASE STUDIES

pneumonia
thyroi
d
Polymerase chain
reaction
For gene amplification
In vivo techniquine
For generating large quality of sp.DNA
Billions of DNA copy

Application - Forensic medicine

- DNA sequencing
- Diagnosis of
enheritance
- Sex determination
 ELISA
▪ It stands for Enzyme linked immunosorbent assay.

▪ It is diagnostic technique which s used for detection of

viruses ,bacteria ,fungi i,drugs ,hormons,etc.

▪ It is based on AG-ABS reaction.

▪ Components- Abs ,Enzyme,Analyte,Substracte

Types – 1) Direct
2) Indirect
3) Sandwich
Equipme
nt 14
1) MICROWELL PLATE 2) Multipipette

3) Washing 4) Microplate
device washer
Western blotting
▪ Western blotting is a laboratory
technique used to detect a specific
protein in a blood or tissue sample.
▪ In this technique a mixture of
proteins is separated based on
molecular weight, and thus by
type, through gel electrophoresis.
▪ Fast and sensitive method that
detects protines.
▪ It works on immuno-
chromatography principle.
Process
Secondary
Sample
antibody Detection
preparation
incubation

Primary Analysis
SDS-PAGE antibody
incubation

Membrane Membrane
transfer blocking
Gel electrophoresis
• Gel electrophoresis is a
laboratory method used
to separate mixtures of
DNA, RNA, or proteins
according to molecular
size.
• In gel electrophoresis,
the molecules to be
separated are pushed by
an electrical eld through
a gel that contains small
pores.
Case report form
. REVIEW OF ORYZANOL 19

PROTOCOL
The aim of the proposed study is to
evaluate effect of gamma-oryzanol, a
nutraceutical on the immunity of
healthy volunteers.

To compare the mean changes in the

immunomodulatory parameters
between the gamma-oryzanol and
placebo groups from baseline to 60
days.
PATHOPHYSIOLOGY AND 3D 20

STRUCTURE OF IDENTIFIED TARGET

► Protein tyrosine phosphatase 1B (PTP1B)
► Glioma KCa channel gene (gBK)
► ) EGFRvIII:
. INTRODUCTION TO REVIEW AND 21

RESEARCH ARTICLES
► Review article: A review article is generally considered a secondary
source since it may analyse and discuss the method and
conclusions in previously published studies.

► Research article: A research article reports the results of original

research, assesses its contribution to the body of knowledge in a
given area, and is published in a peer-reviewed scholarly journal. A
given academic field will likely have dozens of peer-reviewed
journals
BIOCHEMICAL ESTIMATION 22

► ESTIMATION OF GLUCOSE: • To understand the importance of

measuring blood glucose level and to understand the principles of
enzymatic estimation of glucose.

► PRINCIPLE: Glucose is determined after enzymatic oxidation in the

presence of glucose oxidase. The hydrogen peroxide formed
reacts, under catalysis of peroxidase, with phenol and 4-
aminophenazone to form a red-violet quinonimine dye as indicator

► ESTIMATION OF TOTAL PROTIEN

► ESTIMATION OF ALBUMIN
. SEARCH REVIEW ARTICLES 23
REGARDING DIABETES NEUROPATHY
► Diabetic neuropathy is the term that refers to damage of the sensory
nerves that affect the sensation of the body. This is a common
complication of diabetes. Diabetes can damage the nerves in a number
of ways, but all the problems are basically related to blood sugar being
too high for prolonged period of time.
Clinical Protocol Writing 24
Visit to animal house 25

Animals are kept here for

experiments and all testing
purposes which follows
CPCSEA guidelines.
Introduction to Abstract Writing 26

► An abstract is a brief description of a lengthy work. It could be a

thesis a dissertation or a research paper. They are typically
between 100-300 words
Introduction to ICF 27

► INFORMED CONSENT FORM; Informed consent involves providing a

potential participant with: adequate information to allow for an
informed decision about participation in the clinical investigation.
facilitating the potential participant's understanding of the
information.
► 3 major elements
► (1) disclosure of information, (2) competency of the patient (or
surrogate) to make a decision, and (3) voluntary nature of the decision.
 Ethics committee 28

► Ethics Committee is a committee comprising of medical, scientific,

non-medical and nonscientific members.
► Their main responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in a clinical trial
and it shall be responsible for reviewing and approving the
protocol, the suitability of the investigators, facilities, methods and
adequacy of information to be used for obtaining and
documenting informed consent of the study subjects and
adequacy of confidentiality safeguards.
DISCUSSION ON MAIDEN 29

PHARMACEUTICAL CASE STUDY

► • Company - Maiden pharmaceuticals, The World Health
Organization (WHO) issued an alert on Maiden
► • Pharmaceuticals' medical cough syrups for their suspected links
to the deaths of about 66 children in Gambia, Africa, and the
company quickly gained international notice. Haryana, India
► "Laboratory analysis of samples of each of the four products
confirms that they contain unacceptable amounts of diethylene
glycol and ethylene glycol as contaminants, the WHO said in a
medical product alert.
. SLIDE DECK ON CO RELATION 30

BETWEEN COVID 19 AND DIABETES

► There is not enough data to show whether people with diabetes are more
likely to get COVID-19 than the general population. The problem people
with diabetes face is they’re more likely to have worse complications if
they get it, not greater chance of getting the virus. Also, the more health
conditions someone has (for example, diabetes plus heart disease), adds
to their risk of getting those serious complications from COVID-19.
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