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 about1.Chemistry and Manufacturing introduction. 2.Drug substance. 3.Drug Product.

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