The document outlines the studies needed for an Investigational New Drug (IND) submission to the FDA. An IND application must contain information on animal pharmacology and toxicology studies, chemistry and manufacturing, and clinical protocols. It provides a flow chart showing the various preclinical studies required, including chemical and physical properties, biological studies, pharmacology, toxicology, and formulation studies. The goal of the preclinical studies is to generate data for the safety assessment of the new drug in humans.

1. LIST OF STUDIES
NEEDED FOR IND
SUBMISSION
Shivanshu Bajaj
M.Pharma (Pharmacology)
SPER, Jamia Hamdard
New Delhi

2. Contents
■ IND introduction
■ Time period for studies
■ Flow chart showing various preclinical
studies
■ Detailed explanation of studies
■ References

3. Introduction
■ Investigational New Drug (IND) is the key
milestone prior to clinical testing on
humans. Development of IND-enabling
technologies is crucial for accelerate the
discovery of new drugs and significantly
reduce time to market and safety profile
issues. If the application is cleared, the
candidate drug usually enters the clinical
trial stages.

4. Drug discovery and development

5. Preclinical screening
The IND application to FDA (Food and Drug
Administration) must contain information in
three broad areas:
■ Animal pharmacology and toxicology
studies
■ Chemistry and manufacturing information
■ Clinical protocols and investigator
information

6. New
Chemical
Entity
sources:
• Organic
synthesis
• Molecular
modification
• Isolation
from plants
Preclinical Studies
including:
• Chemistry
• Physical Properties
• Biological
• Pharmacology
• Toxicology
• Preformulation
• Long-term animal toxicity
• Product formulation
• Manufacturing and controls
• Package and label design
P.dynamics
P.kinetics
Investigational New
Drug Application (IND)
• Submission
• FDA Review
Flow chart
showing
studies needed
to be
submitted for
IND

7. Preclinical studies of drug
Chemical
properties
colour
viscosity
density
smell
lipophilicity
pH
Freezing
property
Acidity/Basicity
volatility
Boiling
point
Melting
point
Infrared
spectrum
opacity

8. Physical
properties
size
Optical
density
Moisture
content
shape
Flow
properties
hardness
solubility
dissolution

9. Biological
property
Bioinert
bioresorbability
Biocompatibility bioactivity
biodegradibility

10. Preformulaton studies
Bulk character
crystallinity polymorphism
Flow property
Fine particle
character
Solubility
analysis
PKa pH
Common ion
effect
Thermal effect
Dissolution
Stability
analysis
pH rate
Bulk stability
compatibility

11. Toxicity studies
Acute toxicity
study/single
dose studies
Allergenicity
/hypersensitivity
studies
Repeated
dose/sub-acute
or chronic
Genotoxicity
studies
Local toxicity
studies
Carcinogenecity
studies

12. References
1) Loyd V. Allen, Nicholas G. Popovich, Howard C. Ansel -
Ansel's Pharmaceutical Dosage Forms and Drug Delivery
Systems, 9th Edition -Lippincott Williams & Wilkins
(2010)
2) Investigational New Drug (IND) Application
https://www.fda.gov/drugs/developmentapprovalprocess/howd
rugsaredevelopedandapproved/approvalapplications/investiga
tionalnewdrugindapplication/default.htm
3) Understanding FDA Regulatory Requirements for
Investigational New Drug Applications for Sponsor-
Investigators by ME Blair Holbein PhD (Pubmed)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435682/