1. NEW DRUG DEVELOPMENT PROCESS
(NDDP)
Presented by: Avinash Kumar Ch.
M.Pharmacy, Dept. of Pharmacology.

2. What is a Drug..?
According to the Food, Drug, and Cosmetic Act
 a substance recognized in an official pharmacopoeia or formulary.
 a substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease.
 a substance other than food intended to affect the structure or function of the body.
 a substance intended for use as a component of a medicine but not a device or a
component, part, or accessory of a device.
According to WHO
 It is any substance or product that is used or intended to be used to modify or explore
physiological systems or pathological states for the benefit of the recipient.
22 March 20142 NDDP

3. Why new drug is needed..?
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 unmet medical need; new diseases (BSE; AIDS, Alzheimer’s; obesity); low efficacy
(dementia, cancer); side effects (antidepressants, antipsychotics)
 downstream health costs; (Alzheimer’s; spinal injury)
 cost of therapy; (Viagra, Interleukins)
 costs to individual/country; (depression)
 sustain industrial activity; pharmaceutical industry employs thousands and makes a
massive contribution to overseas earnings); patent expiry

4. Drug Development Process
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5. 22 March 2014NDDP5

6. Drug Discovery and Screening
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DRUG DISCOVERY
 Chemical synthesis:
1. Based on SAR - ex. Histamine blockers
2. Based on enantiomers - ex. dopa
 Rational approach: ex. Proton Pump Inhibitors.
 Molecular modelling: ex. COX 2 inhibitors
 Combinatorial chemistry:
 Biotechnology: ex. Growth factors, cytokines.
SCREENING
 Preclinical(Animal)
 Clinical(Human)

7. Preclinical and Clinical evaluation
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Pre Clinical
Testing
Phase I Phase II Phase III FDA Approval
Years 3.5 1 - 2 2 - 4 4 - 6 1.5 Total = 12 - 17
TestPopulation
Laboratory
and Animal
Studies
20 to 100 Healthy
Volunteers
100 – 300 Patient
Volunteers
1,000 to 3,000
Patient Volunteers
Review
Post Marketing
Safety Monitoring
Purpose
Assess
Safety and
Biological
Activity
Determine Safety
and Dosage
Evaluate
Effectiveness. Look
for Side Effects.
Verify Effectiveness,
Monitor Adverse
Reactions from Long-
Term Use
Process
Large Scale
Manufacturing
--------------
Distribution
--------------
Education
%ofall
newdrugs
thatpass
FILEIND
70% of INDs 30% of INDs 27% of INDs
FILENDA
20% of INDs

8. IND & NDA
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IND
 Request submitted to FDA to allow human exposure to the experimental drug.
 It includes
(1) information on the composition and source of the drug,
(2) manufacturing information,
(3) all data from animal studies,
(4) clinical plans and protocols, and
(5) the names and credentials of physicians who will conduct the clinical
trials.
NDA
 Formal proposal for the FDA to approve a new drug for sale in the U.S.
 Must provide sufficient evidence for the FDA to decide:
– Drug is safe and effective.
– Benefits outweigh the risks.
– Proposed labeling is appropriate.
– Manufacturing methods and controls maintain drug identity, strength, quality,
and purity.

9. Ethical bodies
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10. ICH GCP
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 Clinical trials should be conducted in accordance with the ethical principles in the Declaration of
Helsinki
 A trial should be initiated and continued only if the anticipated benefits justify the risks.
 The rights, safety, and well-being of the trial subjects are the most important considerations and
should prevail over interests of science and society.
 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
 The available nonclinical and clinical information on an investigational product should be adequate
to support the proposed clinical trial.
 A trial should be conducted when it receives prior approval/favorable Opinion from independent
ethics committee (IEC)
 Each individual involved in conducting a trial should be qualified by education, training, and
experience.
 All clinical trial information should be recorded, handled, and stored in a way that allows its
accurate reporting, interpretation, and verification.
 Records should be protected, respecting the privacy and confidentiality rules.
 Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP).
 Systems with procedures that assure the quality of every aspect of the trial should be
implemented.

11. GLP
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12. ICMR
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 Principle of essentiality
 Principles of volunteers, informed consent and community agreement
 Principle of non-exploitation
 Principle of privacy and confidentiality
 Principle of precaution and risk minimization
 Principle of professional competence
 Principle of accountability and transparency
 Principle of maximization of public interest and of distributive justice
 Principle of institutional arrangements
 Principle of public domain
 Principle of totality of responsibilities
 Principle of compliance

13. References
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 Betram G, Katzung. Basic and clinical pharmacology. 9th ed. Singapore: Mc Grawhill; 2004.
pp: 67-72.
 Rang. H.P, Dale. M.M, Ritter. J.M, Flower. R.J. , Drug discovery . In: rang & dales
pharmacology, edited by, Kate Dimock & Louise cook, sixth edition, Church hill Livingstone,
pp:781-786.
 http://www.wikipedia.com/3screening/drg%20development%20process/Clinical%20trial
 http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunities
Reports/ucm077262.htm