An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.

1. K.R Manglam University
Gurgaon
INVESTIGATIONAL
NEW DRUG APPLICATION
KOMAL RAO
M.Pharma 1stYear
ROLL NO :2004610001

2. What is IND?
An Investigational New Drug (IND) application allows a sponsor to lawfully
use an investigational drug for the purpose of conducting a clinical investi-
gation of that drug.
1
An investigational drug can be an unapproved drug or an approved product
being studied for a new indication or in a new patient population.2
After completing preclinical testing, the company files an IND with FDA
Act to begin to test the drug in people.3
IND becomes effective if FDA does not disapprove it within 30 days.4

3. The are to assure data quality
and study subject safety.
• In an initial IND submission, the sponsor
provides:
• Pharmacology, toxicology, and manufacturing
information used to assess whethr the product is
reasonably safe for initial testing in humans.
in the development of a new drug begins when the
drug's sponsor has screened the for pharmacological activity
and acute toxicity potential in animals, wants to test its
diagnostic or therapeutic potential in humans

4. TYPES OF IND
 Investigator IND:Submitted by a physician who both initiates and conducts
an investigation, and under whose immediate direction the investigational drug
is administered or dispensed.
-Physician might submit a research IND to propose studying an unapproved
drug, or an approved product for a new indication or in a new patient population
.
 Emergency Use: IND Allows FDA to authorize use of an experimental drug
in an emergency situation. Does not allow time for submission of an IND in
accordance with 2 I CFR , or Sec 312.23.
 Treatment IND: Submitted for experimental drugs showing promise in clinica
l testing for serious or immediately life-threatening conditions while the final
clinical work is conducted and the FDA review takes place.

5. CLASSIFICATION OF IND
 Commercial
Permits sponsor to collect data on clinical safety and effectiveness needed
for application for marketing in the form of NDA
 Permits the sponsor to use drug in research to obtain advanced
scientific knowledge of new drug,
 No plan to market the product .
Non-Commercial

6. DRUG
A drug is, among other things, an article (other than food)
that:
• is intended for use in the diagnosis, cure,
treatment or prevention of disease.
• is intended to affect the structure or any function of the
body.
SPONSOR
An individual or pharmaceutical company, governmental
agency, academic institution, private organization or other
organization who takes responsibility for and initiates a
clinical investigation. The sponsor submits and maintains
the IND.
INVESTIGATOR
An investigator is an individual who actually conducts a
clinical investigation (i.e., under whose immediate
direction the drug is administered or dispensed to a
subject). .
Some
Important
Glosarry

7.  How, Where and by Whom the new studies will
be conducted;
 Chemical structure of the compound;
 How the compound is manufactured;
 Toxic effects in the animal studies.
The IND application shows results of
previous experiments:

8. The IND must contain information in 3
broad areas:
Animal Pharmacology and Toxicology Studies
• Preclinical data to permit an assessment as to whether the product is
reasonably safe for initial testing in humans.
Manufacturing Information(CMC)
• Information pertaining to the composition, manufacture, stability, and controls
used for manufacturing the drug substance and the drug product.
• This information is assessed as to ensure the company can adequately
produce and supply consistent batches of the drug.

9. Detailed protocols for proposed clinical studies to assess whether the
initial-phase trials will expose subjects to unnecessary risks. Also,
information on the qualifications of clinical investigators--professionals (
generally physicians) who oversee the administration of the
experimental compound-to assess whether they are qualified to fulfill the
clinical trial duties

10. Clinical Trials Conducted by IND:
Phase:1
Phase:2
Phase:3
Phase:4(Post Marketing Surveillance)

11. FORMAT OF INDA
A.Cover sheet
• Name, address, telephone of sponsor
• Identification of phases to be conducted.
•Date of application
• Commitment not to begin CT until IND approval
• Commitment by IRB- Form 56 (complies with the requirement)
• Commitment for conducting CT- accordance with regulations
• Name, title of person responsible for monitoring
• Signature of sponsor

12. B.Table of contents
C. Introductory statement & general investigational plan
(a) Name of the drug, pharmacological class drug, structural formula, dosage form,
formulation, route of administration, objective and planned duration of the proposed
clinical investigation.
(b) Identification of countries where drug has been withdrawn from investigation or
marketing for any reasons related to safety and reasons for withdrawal.
D. Investigators brochure :contain the following information
(a) Brief description of the drug (include structural formula) and the formulation.
(b) Summary of the pharmacological and toxicological effects of the drug in the
animals and human.
(c) Summary of pharmacokinetics and biological disposition of the drug in animals .
(d) Summary of information relating to safety and effectiveness in humans from prior
clinical studies.

13. E. Clinical Investigation
(a)Protocol for each planned study.
(b) Investigators Name, Address and CV of each Investigator. Name and address of
each sub-investigator. Name and address of research facilities. Name and address of
IRB.
(c) Monitor- name, title and CV (The person responsible for monitoring the conduct
and progress of the clinical investigation).
Safety monitor- name, title and CV (The person or persons responsible for review and
evaluation of information relevant to safety off the drug.
(d) Labeling for clinical supplies.
F.Chemistry, Manufacturing and Controls Information
(a) Drug substances
Description of physical and chemical characteristics
Name and address of the manufacturer
Method of preparation
Reference standard Specifications
Method of analysis

14. (b) Drug product
Components (reasonable alternatives)
Inactive components- Test and specifications
Components (reasonable variations)
Name and address of manufacturer
Manufacturing and packaging procedure
Specifications
Method of analysis
Stability
Labeling for clinical supplies
Placebo- composition, manufacture and control
Environmental analysis- claim for categorical exclusion
G.Pharmacology and toxicology
(a) Pharmacology and drug disposition Section describing the pharmacological effects
and mechanism of action of the drug in animals.
(b) Toxicology ID and qualifications of persons conducting and evaluating results of
studies concluding reasonably safe to being proposed investigation.

15. H.Previous human experience:Summary of known prior human experience with
the investigational drug to include -
(a) If previously investigated or marketed detailed information about such experience
relevant to safety of proposed investigation or rationale.
(b) For combination of drugs- part 9a information for each drug.
(c) Foreign marketing- List of countries where marketed list of countries where drug
has been withdrawn from marketing for reasons related to safety.

16. A clinical study is required for an IND if it is intended to support a :
01 New indication
02 Change in the approved route of administration or dosage level
03 change Change in the approved patient population
(e.g. pediatric) or a population at greater or increase of risk
(elderly, HIV)
Criteria Of Appliation

17. Application submission
Most INDs are paper submissions. While only 12% of 1NDs are
submitted electronically, 28% of IND Amendments are submitted
electronically a result of maintaining a growing number of INDs
submitted electronically to date.

18. LAWS,REGULATIONS,POLICIES,
PROCEDURES
The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of
the U.S The law is intended to assure consumers that foods are pure and
wholesome, safe to eat, and produced under sanitary conditions; that drugs
and devices are safe and effective for their intended uses; that cosmetics are
safe and made from appropriate ingredients; and that all labeling and
packaging is truthful, informative, and not deceptive..

19. Code of Federal Regulations (CFR):
The regulations apply to the IND application process
are shown in Table.
.