The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.

1. PRESENTED TO :DR. NAGARATHNA P.K.M.
Ass prof., KCP
Department Of Pharmacology
BY : Kashikant Yadav
M pharm (Pharmacology)

2.  Submission application to FDA requesting
permission to initiate the study of New drug
product.
 Pharmaceutical company obtains permission
to clinical trial before a marketing application
for the drug has been approved

3.  FDA reviews the IND application for safety to
assure that research subjects will not be
subjected to unreasonable risk
 Product is reasonably safe for initial use in
humans
 If the compound exhibits pharmacological
activity that justifies commercial development

5. Pharmaceuticals may move across state lines
during two stages of human use
• Research prior to “approval”
– Requires research permit: e.g., Investigational
New Drug Exemption (IND)
• Marketing after “approval”
– Requires marketing permit: e.g., New Drug
Application (NDA)

6.  Applicant (Drug Sponsor):
 who assumes responsibility for the marketing
of a new drug
 IND application provides FDA with data
necessary to decide :
 New drug
 proposed Clinical trial pose a reasonable risk
to human subjects participating in the study

7.  The IND application allows the company to
initiate & conduct the clinical studies of their
new drug Product.
• The safety of the Clinical trial Subjects is
always the primary concern of FDA.

8.  Primary goal of the Sponsor should be to
demonstrate to the FDA that the
- new drug
- proposed trial
- entire clinical development plan described in
the IND is designed to minimize the risk to
the trial subjects.

9.  New chemical entity not approved for the
indication
 Being administered at the new dosage level
 combination with anther drug
 All clinical studies where the new drug is
administered to human subjects

10.  Non clinical studies
 Approved drug and the study is within its
approved indication for use

11.  COMMERCIAL IND : goal is to obtain
marketing approval for a new product.
 NON-COMMERCIAL IND : It includes
 INVESTIGATOR IND :
In this case ,the physician is both the sponsor
and investigator

12.  EMERGENCY IND : FDA authorize immediate
dispensing of a non-approved drug in a life
threatening situation when no standard
acceptable therapy is available.
 TREATMENT IND : FDA will permit
investigational drug to be used to treat a
serious or life threatening disease or if there
is no comparable alternative drug available.

14.  312.20 REQUIREMENTS OF AN IND
• A sponsor shall submit an IND to FDA who
intends to conduct a clinical investigation.
• Investigation is not supposed to begin
without prior written authorization of FDA

15. • Phase 1 - ADME (20- 80) healthy subjects
• Phase 2 – effectiveness in particular
indication (several hundred patients)
• Phase 3 – safety and effectiveness ( 100-
1000) subjects.

16.  To assure safety and rights of the subject.
• To assure the scientific quality of
investigation will yield data capable of
meeting statutory standards for marketing
approval
• Focus should be on general investigational
plan & protocol which should be supported
by additional information including animal
toxicological studies

17. 1. Cover sheet (FORM FDA 1571)
2. Table of contents
3. Introductory statement and a general investigational
plan
4. Investigators brochure
5. Protocols
6. Chemistry , manufacturing and control information
7. Pharmacology and Toxicology information
8. Previous human experience with the investigational
drug
9. Other relevant information like no of IND
submissions
10. Protocol amendments, any changes in the protocol

18.  Name of the sponsor
 Date of submission
 Address
 Telephone number
 Name(s) of Drug
 IND Number
 Indication
 Phase of clinical investigation to be conducted
 list no.of all investigational new drug application
 Serial no.
 Contents of application

19.  Description of clinical studies planned for the
experimental drug
 Purpose of the study
 Indication to be studied
 Types of trials to be initiated
 Number of study subjects
 Risks involved

20.  Structural formula of drug
 Summary of pharmacological , toxicological ,
pharmacokinetic effects in animals
 Safety and efficacy
 Purpose of study
 Dose / dose frequency
 Monitoring procedures

21. - It describes – the objective of the study
- the trial design
- how subjects would be selected
- how the trail is to be conducted.

22.  Determines the adequacy of methods used to
manufacture and assay investigational
compound
 Safety concerns
 Describe drug substances
 Method of preparation
 Reagent and solvents
 Acceptable limits and analytical methods to
ensure quality and purity of drug.

23.  non-clinical safety data that sponsor
generated to prove that the IP is safe for
clinical study .
 the amount & type of data depends on class
of new drug duration of proposed clinical
trial, patient population that will be exposed
during the trial

24.  Pk studies
 Pd studies
 observed adverse event profile

25.  purpose of this section is to facilitate the
availability of promising new drugs to
desperately ill patients
 In the case of an immediately life-threatening
disease, a drug may be made available for
treatment use under this section earlier than
Phase 3, but ordinarily not earlier than Phase
2.

26.  The “treatment use” of a drug includes the
use of a drug for diagnostic purposes.
 If a protocol for an investigational drug meets
the criteria of this section, the protocol is to
be submitted as a treatment protocol

27. A treatment protocol is required to contain the
following:
• The intended use of the drug.
• An explanation of the rationale for use of the
drug,
• A brief description of the criteria for patient
selection, The method of administration of
the drug and the dosages.
• A description of clinical procedures,
laboratory tests, or other measures.

28.  Once the IND is stamped as received , it is
sent to CDER for review.
• It is further categorically divided into
different sections –
 Medical
 Chemistry
 Pharmacology / Toxicology
 Statistics

29.  Safety Review
 Clinical Hold Decision
 Notify Sponsor
 Sponsor Notified of Deficiencies
 Study Ongoing
• Once CDER's 30-day initial review period
expires, clinical studies can be initiated,
unless a clinical hold has been placed.

30. 1.Helps in the result of successful preclinical
development program.
2.IND is also the vehicle through which a
sponsor advice the next stage of drug
development i.e. clinical trial.
3. The preclinical study, helps the sponsor’s
primary goal to determine that the product is
reasonably safe for initial use in human.
4.It is important in the commercial
development of compounds if it exhibit
pharmacological activity.
5.It is important in assuring the marketing of a
new drug and responsibility for compliance of
sponsor.

31. 6. It is important for the company to initiate
and conduct the clinical studies of their new
product.
7. It secure the safety and effectiveness of the
clinical trial subjects.
8.IND can be alternative in a life threatening
situation when no standard acceptable
therapy is available.
9.It gives the indication of new drugs.
10. Pharmacology and toxicology information
of new drugs.