NEW DRUG DEVELOPMENT PROCESS (NDDP)

Presented by: Avinash Kumar Ch.

M.Pharmacy, Dept. of Pharmacology.

April 10, 2023NDDP2

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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Why new drug is needed..?

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

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Drug Development Process

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Drug Discovery and Screening

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)

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Preclinical and Clinical evaluation

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

Te

st P

opul

atio

n 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

Pu

rpos

e

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

% o

f all

new

drug

s th

at p

ass

FILE

IND

70% of INDs

30% of INDs

27% of INDs

FILE

ND

A

20% of INDs

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IND & NDA

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.

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Ethical bodies

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ICH GCP

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.

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GLP

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ICMR 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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References 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/CriticalPathOpportunitiesReports/ucm077262.htm