PRESENTATION

ON
DRUG DEVELOPMENT TECHNOLOGIES

Guided by: Presented by:

Dr Sunil Chandiwal Dipti khandelwal
Faculty IMS,DAVV, Ruchi patidar
 WHAT IS DRUG DEVELOPMENT?

 Drug development or preclinical development is defined in

many pharmaceutical companies as the process of taking a
new chemical lead through the stages necessary to allow it
to be tested in human clinical trials.
 CLINICAL TRIALS
c l i n i c a l t r i a l s   a r e c o n d u c t e d to a l l o w sa f e t y
a n d   e ff i c a c y   d a t a t o b e c o l l e c t e d f o r he a l t h
i n t e r ve n t i o n s ( e . g . , d r u g s, d e v i c e s, th e r a p y
p r o to c o l s ) .

c l i n i c a l t r i a l s gi v e s a c l i ni c i a n m a n y a ns w e r s t o
q u e s t i o n s f r om t he p o i n t o f p r e ve n t i o n, d e t e c t i o n
d i a g n o s i s , c on t r o l a n d t r e a t m e nt of i l l n e s s o r a
c o nd i t i o n s u c h a s c a n c e r.

c l i n i c a l t r i a l s a t t e m pt t o i m p r o v e a p a t i e n ts q u a l i ty
of life.
 PURPOSE

 It is explained by some questions which could be answered by

doing a clinical trial are:
 Whether the drug and device is safe and effective for people to use?
 Compare various existing treatment to determine which is better?
 How helpful the treatment is?
 What are the side effect that occur as result of new treatment or
drug?
 Current approved treatment are called the “standard treatment”.
It is use to study different ways to use the standard treatments so
they will be more effective ,easier to use, and decrease side-effects
 How serious the side-effects are when compare to standard
treatment options?

 Do the benefits out way the side-effects?

 Which group of people are most likely to benefit from the

new drug/treatment?
 DIFFERENT TYPES OF CLINICAL
TRIALS
 TREATMENT TRIAL

 PREVENTION TRIAL

 DIAGNOSTIC TRIAL

 SCREENING TRIAL

 SUPPORTIVE / QUALITY OF LIFE TRIALS

1)TREATMENT TRIAL:
Trial that test new treatment,newcombinations of drug or new
approaches to surgery or radiation therapy.

2)PREVENTION TRIAL:
Trials look for better race to prevent disease in people who have
never had the disease. Also prevent the reoccurrence in those
already having the disease.

3) DIAGNOSTIC TRIAL:
Trials for developing new trials or procedures to identify
particular disease or health condition by comparing the
diagnostic performance of new treatment with the standard
treatment.
4)SCREENING TRAILS:
Detecting diseases or health conditions before they start to
appear as symptom.

5) SUPPORTIVE/QUALITY OF LIFE TRIALS:

Exploring quality intervention that can improve quality of
life and comfort level of individuals suffering from chronic
disease conditions.
 DRUG DEVELOPMENT PROCESS

PRECLINICAL RESEARCH

LICENSING AUTHORITY

PATIENT ENROLLMENT
CLINICAL TRIALS

PHASE-1 PHASE-2 PHASE-3 PHASE-4

 ANALYSIS

PUBLICATION

APPROVAL
 DRUG DEVELOPENT PROCESS
1)Preclinical research:-
It is the process where scientists and researchers determine –
What germs ,viruses or bacteria cause a specific disease.

What abnormal events or processes are taking place in the body.


Then scientists work to develop a drug that will treat these

Abnormalities by conducting experiments in test tubes.

2)Licensing authority
3) Patient enrollment:-
 Patients are identified by screening.

Investigational new drug(IND) application

4)Clinical trials:-
 PHASES OF CLINICAL TRIAL

Phase 1-
 A new drug is administered to approximately 20 to 80
healthy individuals to study the activity and monitor the
potential toxicity in people.
 Thos process takes place in about 1 year and if successful will
lead to phase 2 trial.

Phase 2-
 The drug is given to 1oo-300 volunteers with the disease being
studied to determine the drug effectiveness.
 This process can take about 2 years to complete.
Phase 3-
 It involves 1000 to 3000 volunteers with the specific
disease and that are in clinics or hospitals.
 Physicians will monitor these patients closely to
determine the effects of the drugs and determine if
any side effects are involved.
 It also determines affectivity and safety of drugs,
optimum dosage, frequency of administration,
and common adverse reactions of the compound.
 It takes 3 years.
Phase 4-
 These studies are designed to reveal adverse
reactions to prolonged usage, drug efficacy in long
term use, an assessment of misuse or overuse
liability, drug interactions with other agents.
 POSSIBLE BENEFITS AND RISK OF TRIALS

POSSIBLE BENEFITS POSSIBLE RISKS

1. Access to currently There might be a possibility
available therapies that of participants receiving a
could be potentially more placebo/inactive pill in
effective compared to certain type of trails
already available
therapies.
2. Opportunity to be In comparison to the
treated by the best standard therapies
doctors in the field. available, the new therapy
may be less effective.
 TO BE CONT…..

3. In some trials Participating in a phase -1

participants could receive trial might involve more
lab investigations as well risk when compared to
as new treatment /drugs phase -3 trials due to lack
free of cost of knowledge of new
treatment/drug side-
effects
4. Continuously being There may be certain areas of
monitored during the various the clinical trials that may not
stages of trials for possible be covered by insurance
side-effects companies
 WHY TO CHOOSE INDIA FOR CLINICAL TRIALS?
 

India has well-defined guidelines for carrying out various phases of clinical

trials. These guidelines are in line with the global guidelines on clinical
research (ICH-GCP). The various guidelines that governs the conduct of
clinical trials in India includes:
Schedule Y of Drugs and Cosmetics Act, 1940
Ethical Guidelines for Biomedical Research on Human Subjects, 2000 also
known as ICMR Code
Good Clinical Practices, 2001
 

1. Speed 
 
 
 
2. patient enrolment
3. wide spectrum of diseases
4. quality of data
5. economic environment
6. alignment with gatt/trips/WTO
7. infrastructure 
8. proficiency in english language
 
CLINICAL TRIAL CENTRES IN INDIA

 Central drug research institute (CDRI) lucknow.

 Centre for cellular and molecular biology(CCMB)

Hyderabad.

 Indian institute of chemical biology Kolkata.

 Metropolis health services (India) pvt ltd worli Mumbai

 Institute of microbial technology Chandigarh.

 DRUG DELIVERY SYSTEM

 It is the method or process of administering a

pharmaceutical compound to achieve a therapeutic effect in
the humans or animals.

DOSAGE FORMS : DESIGN PARAMETERS:-

Drugs are rarely administered in their pure forms and
more often than not; they have to be necessarily admixed
with various kinds of adjuncts resulting in their
transformations into so called ‘dosage forms’ or ‘drug
delivery system’.
Physicians viewpoint:-
A physician would like to treat his patient with a dosage
form that can provide the drug to the system according to
the preordained pattern. In an era of multifarious dosage
forms of a single drug the physicians task to select the right
brand is onerous.

Pharmaceutical scientists concern:-

The manufacturers or pharmaceutical products are
morally, legally and socially responsible for the qualities of
their products.
Patients expectations:-
The dosage form must be acceptable to patients senses
or in other words be organoleptically amicable. Hence ,it is
almost mandate for drug formulators that their
formulations should have an agreeable appearance,
desirable sensual characteristics and as likeable taste , good
flavor , alternative colour etc.
 CLASSIFICATION OF DOSAGE FORMS

1. Form wise
2. Route wise
3. Release rate

FORMWISE:-
a. Solid dosage forms
b. Liquid dosage forms
c. Semisolid dosage forms
 SOLID DOSAGE FORM
solid dosage form

Unit dosage
Bulk
form

Powders(wr For internal For external

pills capsules chachets
apped) use use
 LIQUID DOSAGE FORM

liquid dosage
Liquidform
dosage form

monophasic biphasic

external internal emulsions suspension

 SEMI SOLID FORM

Semi solid dosage

forms

For external
For internal use
use

ointments plasters suppositories electuaries

 ROUTE OF ADMINISTRATION

Path by which a drug fluid, poison or other

substance is brought into contact with the body.

Classification:-
1. Topical – local effect
2. Enteral – desired effect is non local i.e. systemic.
3. Parental – desired effect is systemic.
TOPICAL:-
Substance is directly applied where action is desired. It
may be:-
 Epicutaneous
 Inhalation
 Enema
 Eye drops
 Ear drops
 Intra nasal route
 Vaginal
ENTERAL:-
The substance is given via digestive tract.It may be:-
 By mouth (orally);
 By gastric feeding table, duodenal feeding tube;
 Rectally.

PARENTAL:-
By injection or infusion:
 Intravenous
 Intra-arterial
 intramuscular
 Intracardiac
 Subcutaneous (under the skin)
 Intradermal ( into the skin itself)
 Intraosseous ( into the bone marrow )
 Intrathecal ( into the spinal canal)
 Intraperitoneal ( into the peritoneum)
 Intravesical ( into the urinary bladder)
Other parentral:-
transdermal,transmucosal,epidural and intravitreal
TARGETWISE:-

The drugs are classified as –

 Sustained action
 Prolonged action
 Repeat action
 Signal oriented
 Target oriented
 DRUG COMPLIANCE

 It is a medical term that is used to indicate a patient’s

correct following of medical advice.

 Most commonly it is a patient taking medicine, but may

also apply to use of surgical appliance such as
compression stockings, chronic wound care, self directed
physiotherapy exercises or attending councils or other
courses of therapy.

 Can be improved through a positive physician -patient

relationship.
 Other factors that increase compliance

 Patient feeling ill

 Limitations of patients activities due to disease state
 Acute illness
 Simple treatment schedule
 Short time spent in waiting room
 Physician recommending out change at a time
 Peer support.
 Causes for poor compliance

 Forgetfulness
 Poor support with physician
 Chronic illness
 Few symptoms
 Prescription not collected
 Purpose of treatment not clear
 Perceived lack of effect
 Cost of drugs
 Real or perceived side effects
 Instructions for administration not clear
 Unpleasant taste.
 PHARACODYNAMICS
 The study of biochemical and physiological effects of drugs
on the body or on microorganisms or parasites within or in
the body and the mechanism of drug action and the
relationship between drug concentration and effect.

EFFECTS ON THE BODY:-

Majority of the drugs either a) mimic or inhibit normal

physiological/biochemical process or inhibit pathological
process in animals or
b)inhibit vital process of endo or ectoprasites and microbial
organisms.
There are 5 main drug actions:-
 Depressing
 Stimulating
 Destroying cells
 Irritation
 Replacing substances

DESIRED ACTIVITY:-
The desired activity of the drug is mainly due to one
Of the following:-
1. Cellular membrane disruption
2. Chemical reaction
3. Interaction with enzyme proteins

4. Interaction with structural proteins

5. Interaction with carrier proteins

6. Interaction with ion channels

7. Ligand binding to receptors

UNDESIRABLE EFFECTS
The undesirable effects of a drug includes:-
1. Increased probability of cell mutation(carcinogenic
activity)
2. A multitude of simultaneous assorted actions which may
be deleterious.
3. Interaction (additve,multiplicative or metabolic)
4. Induced physiological damage or abnormal ahronic
conditions.
THANK YOU