1. NEW DRUG DEVELOPMENT PROCESS
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.
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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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6. Drug Discovery and Screening
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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
Biotechnology: ex. Growth factors, cytokines.
7. Preclinical and Clinical evaluation
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Phase I Phase II Phase III FDA Approval
Years 3.5 1 - 2 2 - 4 4 - 6 1.5 Total = 12 - 17
20 to 100 Healthy
100 – 300 Patient
1,000 to 3,000
for Side Effects.
Reactions from Long-
70% of INDs 30% of INDs 27% of INDs
20% of INDs
8. IND & NDA
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Request submitted to FDA to allow human exposure to the experimental drug.
(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
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,
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
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
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
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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
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Betram G, Katzung. Basic and clinical pharmacology. 9th ed. Singapore: Mc Grawhill; 2004.
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,