Investigational new drug application (ind)

1. Investigational New Drug Application
(IND)
 Siddu K M
 M Pharm 1st year
 Department of Pharmaceutics
 Al Ameen College of Pharmacy

2. CONTENTS
1. INTRODUCTION
2. WHEN DO I NEED AN IND ?
3. CATEGORIES OF IND
4. CONTENT & FORMAT OF IND APPLICATION
5. IND REVIEW PROCESS

3. INTRODUCTION
 An IND is an application submitted to the Food and Drug
Administration (FDA) requesting permission to initiate a clinical
study of a new drug product.
 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.

4. 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.

5. Categories of IND
 COMMERCIAL IND : To obtain marketing approval for a new
product.
 NON-COMMERCIAL IND :
 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 threatening disease or if there is no comparable alternative drug available.

6. Content & Format of IND Application
The content & format of IND is laid out in 21 CFR part 312.
1. Cover sheet – 312.23(a)(1)
2. Table of contents – 312.23(a)(2)
3. Introductory statement & general investigation plan- 312.23(a)(3)
4. Investigators brochure – 312.23(a)(5)
5. Clinical protocol – 312.23(a)(6)
6. CMC – 312.23(a)(7)
7. Pharmacological & toxicological information – 312.23(a)(18)
8. Previous human exposure – 312.23(a)(9)
9. Additional information – 312.23(a)(10)

7. COVER SHEET
It includes name, address, contact details of sponsor.
Name of the drug, IND number and date of submission along with signature.
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

8. INVESTIGATORS BROCHURE
Investigators brochure is a comprehensive document summarising the body of
information about an investigational product obtained during clinical trial.
CLINICAL PROTOCOL
A clinical protocol describes how a particular clinical trial is to be conducted
It describes
 the trial design
 how subjects are selected
 how the trial is carried out

9.  CHEMISTRY, MANUFACTURING AND CONTROL DATA
• Determines the adequacy of methods used to manufacture and assay
investigational compound
• Safety concerns
• 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 previously tested in humans.