Investigational new drug application new

INVESTIGATIONAL NEW DRUG
APPLICATION
(IND)

05-09-2011

INTRODUCTION
What is an IND ?

 An IND is a submission to the food and drug
administration (FDA) requesting permission to initiate a
clinical study of a new drug product.

 The Federal Food , Drug and Cosmetic act requires that
drugs have an approved marketing application before they
can be shipped in interstate commerce.

 The IND application allows a company to initiate and
conduct clinical studies for their new drug products.

 The IND application provides the FDA with the data
necessary to decide whether the new drug and the
proposed clinical trial pose a reasonable risk to the human
subjects participating in the study.

When Do I Need An IND ?
 An IND is required any time I want to conduct a clinical
trial of an unapproved drug.
 An IND would be required to conduct a clinical trail if the
drug is
 a new chemical entity , not approved for the indication
under investigation in a new dosage form.
 Being administered at a new dosage level.
 in combination with another drug and the combination is
not approved.

 All clinical studies where a new drug is administered to
human subjects , regardless of whether the drug will be
commercially developed , require an IND.

When You Don’t Need An IND
 An IND is not required to conduct a study if the drug :
 is not intended for human subjects , but is intended for in
vivo testing or lab research animals (non clinical studies).
 is an approved drug and the study is within its approved
indication for use.

CATEGORIES OF IND
 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.
 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 threaetning disease or if there is
no comparable alternative drug available.

Pre-IND Meeting
 A meeting between the sponsor and the fda frequently is useful
in resolving questions and issues raised during the preperation
of an ind.
 The fda encourages such meetings to the extent that
 They aid in the solution of scientific problems and
 To the extent that the fda has available resources.
 Most issues and questions are usually related to the
 Design of animal studies needed to initiate the clinical trials.
 The scope and design of the initial study in humans.

 Meeting should be scheduled to occur within 60 days of
the FDA’s receipt of the written request for the meeting.
 A briefing document is required at least 4 weeks prior to
the meeting.
 The briefing document should provide summary of the
information related to the product.

ESSENTIALS OF AN IND
 IND must present adequate information to permit the FDA
to evaluate the drug’s suitability for use in the proposed
clinical study.
 The central focus of the initial ind should be the general
investigational plan and the protocol for the 1 st proposed
human study.
 To assure that the human subjects who participate in the
proposed study will not be exposed to unreasonable and
significant risk.

Content And Format Of An IND Application
 The content and format of an initial ind is laid out in 21 CFR
part 312 .
1. Cover sheet – 312.23(a)(1) FDA form 1571
2. Table of contents – 313.23(a)(2)
3. Introductory statement and general investigational plan –
312.23(a)(3)
4. Investigators brochure – 312.23(a)(5)
5. Clinical protocol – 312.23(a)(6)
6. Chemistry , manufacturing and control data – 312.23(a)(7)

7. Pharmacological and toxicological information –
312.23(a)(18)
8. Previous human exposure – 312.23(a)(9)
9. Additional information – 312.23(a)(10)
10. Relevant information – 312.23(a)(11)

FORM FDA 1571
1.Name of the sponsor :
 He is the person who takes responsibility for and initiates
a clinical investigation.
 May be a pharmaceutical company, a private or academic
organization, or an individual.

2.Date of submission :
 It is the date when the application is mailed to FDA.
3. Address :
 It is the address to which written correspondence from
FDA should be directed.

4. Telephone number :
 It is the number where the sponsor is usually available
during normal working hours. A telephone number
must be provided.
5. Name(s) of Drug :
 List the generic name(s) and trade name, if available.
Also, state the dosage form(s).

6. IND Number :
 If an emergency IND number was previously assigned by
FDA, or the Form FDA 1571 is being included with an
amendment to the original IND, then that IND number
should be entered here; otherwise, the space should be left
blank.
7. Indication
8. Phase of clinical investigation to be conducted
9. list no.of all investigational new drug application

10. Serial no.
11. Contents of application
12.Name and title of the person responsible for monitoring
the conduct and progress of clinical investigation
13. Is any part of the clinical study to be conducted by CRO
13. Name and title of the person responsible for review and
evaluation of information relevant to the safety of drug
14. Name of sponsor’s authorised representative
15.Signature
16.Address
17.Telephone no.
18.Date

INTRODUCTORY STATEMENT

 Description of the investigational drug
 All active ingredients
 Drug’s pharmacological classification
 Structural formula
 Route of administration
 Summary of previous human experience
 Formulation of dosage forms
 Objective and planned duration of proposed clinical
investigation.

INVESTIGATIONAL PLAN
 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

INVESTIGATORS BROCHURE

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

CLINICAL PROTOCOL
 a clinical protocol describes how a particular clinical trial
is to be conducted
 It describes
 the objectives of study
 the trial design
 how subjects are selected
 how the trial is to be carried out

 It should contain the following elements:
 A statement of the objective and purpose of study.
 Name , address and qualification of each investigator
participating in the study.
 Name and address of each clinical site.
 Study subject inclusion and exclusion criteria.
 Estimate of the number of subjects to be enrolled in the
study.

Chemistry,Manufacturing and Control Data
 Determines the adequacy of methods used to manufature
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.

Pharmacological and Toxicology data :
 Pharmacology and drug disposition
 Integrated toxicology summary

Previous human exposure :
 Marketed (foreign) or previouly tested in humans.

FDA REVIEW OF THE IND
 Once the ind is stamped as received ,it is sent to the review
division within CDER.
 On arrival at the review division , it is critically evaluated by
several reviewers of
 Chemisty
 Biopharmaceutics
 Medical
 Stastistics
 Microbiology
 Pharmacology /toxicology sections

 All these areas review the data submitted with the primary
purpose to ensure safety of the individual enrolled in th e
study.
 Once an IND is submitted,the study can’t be initiated until
a period of 30 days.
 If there are any major issues relating to the safety of the
volunteers in the proposed study , the FDA can institute a
clinical hold.

IND ANNUAL REPORTS
 Sponsors should submit an annual report that provides the
FDA with a brief update on the progress of all
investigations included in the IND.
 It should contain the following:
 Individual study information.
 Summary of the study.
 Listing of any significant foreign marketing developments
with the drug e.g. approval in another country.

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