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IND

INVESTIGATIONALNEW DRUG APPLICATION

PRESENTED BY : ASHWANI GOYAL

M.PHARMACY 1ST SEMESTER

CHITKARA SCHOOL OF PHARMACY

CHITKARA UNIVERSITY

Himuda Educational Hub

Barotiwala

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Important Terms1.Sponsor: A manufacturer or a person or a party who wants to

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 Organisat

5.Investigator: A person or a team which plans, coordinates and

clinical study of new drugs on humans executed.

6.Preclinical studies: Initial pharmacological studies done on afind efficacy, safety and toxicity and whether they can be utiliz

human studies.

7.Clinical studies/Trials: Pharmacological studies done on limi

number of human volunteers after a positive preclinical repor

efficacy, safety and toxicity on human use and establish dosag

and treatment methods.

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WHAT IS IND?

The IND is the means through which the sponsor technically ob

exemption from the FDA.

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TYPES OF IND

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IND CATEGORIES

1. COMMERCIAL

2. RESARCH (NON COMMERCIAL)

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IND APPLICATION MU

CONTAINS INFORMATABOUT

1. ANIMAL PHARMACOLOGY AND TOXIXOLOGY ST

2. MANUFACTURIN INFORMATION.

3. CLINICAL PROTOCOLS AND INVESTIGATORS

INFORMATION.

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IND APPLICATION

PROCEDURE

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yes

NO

continued

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Chemistry reviewers address issues related to drug identity, manuf

control, and analysis. The reviewing chemist evaluates the manufa

processing procedures for a drug to ensure that the compound is ad

reproducible and stable.

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Following review of an initial IND submission, CDER has 30 cale

which to decide if a clinical hold is necessary.

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DETAILS REQUIRED TO

PROVIDED WITH IND

APPLICATION

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This should be submitted to assure the pr

identification, quality, purity, and strengt

investigational drug.It includes information about-

1.Chemistry and Manufacturing introduc

2.Drug substance.

3.Drug Product.

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