IND

INVESTIGATIONAL
NEW DRUG APPLICATION

PRESENTED BY : ASHWANI GOYAL

M.PHARMACY 1ST SEMESTER
CHITKARA SCHOOL OF PHARMACY
CHITKARA UNIVERSITY
Himuda Educational Hub
Barotiwala
 Important Terms
1.Sponsor: A manufacturer or a person or a party who wants to proceed
with commercialization and selling of a product.
2.FDA: Food and Drug authority.
3.CDER: Centre for drug evaluation and research (USA).
4.CDSCO: Central Drug Standardisation and Control Organisation (India).
5.Investigator: A person or a team which plans, coordinates and gets a
clinical study of new drugs on humans executed.
6.Preclinical studies: Initial pharmacological studies done on animals to
find efficacy, safety and toxicity and whether they can be utilized for
human studies.
7.Clinical studies/Trials: Pharmacological studies done on limited
number of human volunteers after a positive preclinical report, to find
efficacy, safety and toxicity on human use and establish dosage regimen
and treatment methods.
 WHAT IS IND?

The IND is the means through which the sponsor technically obtains this
exemption from the FDA.
TYPES OF IND
IND CATEGORIES
1. COMMERCIAL

2. RESARCH (NON COMMERCIAL)

 IND APPLICATION MUST
CONTAINS INFORMATION
ABOUT
1. ANIMAL PHARMACOLOGY AND TOXIXOLOGY STUDIES.

2. MANUFACTURIN INFORMATION.

3. CLINICAL PROTOCOLS AND INVESTIGATORS

INFORMATION.
IND APPLICATION
PROCEDURE
continued

NO

yes
Team is staffed by pharmacologists and toxicologists who evaluate the results of
animal testing and attempt to relate animal drug effects to potential effects in
humans.

Study carried:
Pharmacology and Drug Distribution:
1)Pharmacologic effects and mechanism(s) of action of the drug in animals.
2)Information on the absorption, distribution, metabolism, and excretion of the
drug.
Toxicology Data
Summary of the toxicologic effects of the drug in animals and in vitro.
Chemistry reviewers address issues related to drug identity, manufacturing
control, and analysis. The reviewing chemist evaluates the manufacturing and
processing procedures for a drug to ensure that the compound is adequately
reproducible and stable.
Following review of an initial IND submission, CDER has 30 calendar days in
which to decide if a clinical hold is necessary.
DETAILS REQUIRED TO BE
PROVIDED WITH IND
APPLICATION
This should be submitted to assure the proper
identification, quality, purity, and strength of the
investigational drug.
It includes information about-
1.Chemistry and Manufacturing introduction.
2.Drug substance.
3.Drug Product.