drug development, IND, withdrawl of IND, exemption, IND review,

1. Investigational New Drug (IND)
Presented by-
Manish Kumar Singh
(M.Pharm I Year)
Presented to-
Ms. Alka
Assistant Professor
Faculty of Pharmacy, BBDNIIT Lucknow

2. Drug Development :
 Drug development is the process of bringing a new
pharmaceutical drug to the market once a lead
compound has been identified through the process of
drug discovery.
 It includes pre-clinical research on microorganisms
and animals, filing for regulatory status, such as via
the United States Food and Drug Administration for
an investigational new drug to initiate clinical trials on
humans, and may include the step of obtaining
regulatory approval with a new drug application to
market the drug.

4. Agencies for Drug Approval :
 The following table indicates about the group of agencies working for drug
approval procedure in their respected countries.

5. Preclinical Studies :
 Computer stimulation, experimental animal studies, or in-
vitro studies are performed to-
1. Identify a promising drug
2. Test for promising biological effect
3. Test for adverse effect
A drug company may test many related compounds to identify
1 or 2 to take further in development. The FDA is not involved
in this aspect of drug development but will review the study
results for any compounds that are planned for clinical
(human) testing.

6. Introduction :
Investigational New Drug (IND) – It is the formal process by
which a sponsor requests approval for testing a drug in humans-
includes information developed during preclinical testing
regarding safety and effectiveness.
Includes an “investigator brochure” that ensure that clinicians
conducting the trial and their institutional review boards (IRBs)
are adequately informed about possible effects of the drug.
Once IND application is submitted, the sponsor must wait for 30
days before initiating any clinical trials.

7. There are two IND categories :
• Commercial INDs – These are applications that are submitted primarily by the
companies to obtain marketing approval for a new product.
• Non-Commercial INDs – These INDs are filed for noncommercial research.
Types of IND :
• Investigator INDs - This is submitted by a physician who both initiate and
conducts an investigation and under whose immediate direction the investigational
drug is administered or dispensed.
• Commercial INDs – They are application that are submitted by companies whose
ultimate goal is to obtain marketing approval for a new product.
• Emergency use INDs - This IND allows the FDA to authorize use of an
experimental drug in an emergency situation that does not allow time for submission
of an IND in accordance with 21CFR Sec.312.23 or Sec.312.34.
• Treatment INDs - Other name is expanded access IND , this IND may be
submitted for experimental drugs showing promise in clinical testing of serious or
immediately life-threatening conditions while the final clinical work is conducted
and the FDA review takes place (21CFR312.34).

8. The IND application must contain
information in three broad areas
 Animal pharmacology and toxicology studies.
 Manufacturing information.
 Clinical protocols and investigator information.

9. Guidance documents to help prepare
INDs include :
 Guidance for industry : cGMP for phase 1 investigational drug.
 Guidance for industry : Exploratory IND studies.
 Content and format of INDs for phase 1 studies of drug including well characterized,
therapeutic, biotechnology-derived products.
 Q & A - Content and format of INDs for phase 1 studies of drug including well
characterized, therapeutic, biotechnology-derived products.
 Bioavailability and Bioequivalence studies for Orally Administered Drug
Products – General considerations. This guidance should be useful for applicant
planning to conduct BA and BE studies.
 IND exemption for studies of lawfully marketed drugs or biological for the treatment
of cancer.
 Drug Master File (DMF) : A DMF is submission to FDA that may be used to
provide confidential detailed information about facilities, processes, or articles used
in the manufacturing, processing, packaging and storing 1 or more human drugs.
 Immunotoxicology evaluation of investigational new drug : This guidance make
recommendations to sponsors of INDs on the parameters that should be routinely
assessed in toxicology studies to determine effects of a drug on immune function.

10. Law, Regulations, Policies and Procedures :
Code of Federal Regulations (CFR)
• Investigational New Drug Application21CFR Part 312
• INDA and NDAApplications for FDA
approval to market a new drug.21CFR Part 314
• Orphan drugs.21CFR Part 316
• Good lab practice for non clinical
laboratory studies21CFR Part 58
• Protection of human subjects.21CFR Part 50
• Institutional Review Board.21CFR Part 56
• Drug Labeling21CFR Part 201
• Financial Disclosure by Clinical
Investigators.21CFR Part 54

11. Content of an IND :
 Cover sheet (form FDA 1571)
 Table of contents.
 Introductory statement and general investigational
plan.
 Investigator’s brochure.
 Protocols.
 Chemistry, manufacturing and control information.
 Previous human experience with the
investigational drug.
 Additional information.

12. Exemptions :
 Clinical studies conducted with marketed drugs are
exempted from IND regulations provided that the
investigation are conducted in compliance with the
institutional review (21CFR 56) & informed
consent (21CFR 50) requirements and the
regulation prohibiting the promotion or sale of
investigational drugs.

13. Withdrawal of an IND :
 AT any time sponsor can withdraw an effective
IND. In such a case, FDA & IRB shall be so
notified with reason for withdrawal, all clinical
studies ended, all current investigators and subject
notified, all stocks of drug returned to the sponsor
or otherwise disposed off an request of sponsor in
accordance with 312.59.

15. References :
 https://www.google.co.in/search?q=drug+development+proces
s+images&rlz=1C1CHBF_enIN815IN815&oq=drug+develop
ment+process+images&aqs=chrome..69i57.18166j0j8&source
id=chrome&ie=UTF-8
 Mulaje et al (2013). Procedure For Drug Approval in Different
Countries : A Review. Journal of Drug Delivery &
Therapeutics; 2013, 3(2), 233-238
 Kaur J., (2014). US FDA Drug Approval Strategies for
Pharmaceutical Industry. International Journal of
Pharmaceutical Science Review and Research, 25(1),Mar-Apr
2014; Article no. 24, Page no. 137-146.