This document provides an overview of non-clinical (pre-clinical) drug development. It discusses key terminology used in pre-clinical development like CTD, NOAEL, IND, NCE, NDA. It explains that pre-clinical development spans the gap between discovery and first-in-human clinical trials, with the goal of identifying the safest lead candidate and building a scientific foundation for clinical trials. The document outlines the main components of pre-clinical development, including pharmacology studies, safety pharmacology, PK/ADME studies, toxicology studies, and starting dose selection. It notes that pre-clinical studies must adhere to ICH GLP guidelines. The CTD pyramid is also discussed as the common

1. NON CLINICAL DRUG
DEVELOPMENT.
Mentor- Mr. Manindra Mahapatra Sir. Presented By- Abhimanyu Awasthi

2. Slide Title
Basic Terminology Involved in Non/Pre Clinical Drug Development.
CTD Common Technical Document.
NOAEL Non-Observed Adverse Effect Level.
RAID Rapid Access to Intervention Development (preclinical program).
IND Investigational New Drug application.
NCE New Chemical Entity.
NDA New Drug Application.
CoA Certificate of Analysis.
CRO Contract Research Organization.
CTM Clinical Trial Material.
FIH First in Human.
NME New Chemical Entity.
IMPD Investigational Medicinal Product Dossier.
CTA Clinical Trial Agreement.
MAA Marketing Authorization Application.
BLA Biologics License Applications.

3. Slide Title
Non Clinical(Pre Clinical) Drug Development
 All the activities required before a new molecular entity can be administered to humans
Spans gap between discovery/screening to FIH clinical trials & Provides key pharmacological information
z about a drug candidate
 The non-clinical (or pre-clinical) development phase primarily aims to identify which candidate therapy
has the greatest probability of success, assess its safety, and build solid scientific foundations before
transition to the clinical development phase.
 Preclinical studies can be designed to identify a lead candidate {drug} from several hits; develop the best
procedure for new drug scale-up; select the best formulation; determine the route, frequency, and
duration of exposure; and ultimately support the intended clinical trial design.
 Also, during the non-clinical development phase, the candidate compound should meet non-medical
objectives, including defining the intellectual property rights and making enough medicinal product
available for clinical trials. The non-clinical development of a medicine is complex and regulatory-driven.

4. Slide Title
Desgining of Pre-Clinical Tirals

5.  Pharmacology Studies
 Safety Pharmacology
 PK/ADME Studies
 Toxicology
 Starting Dose Selection and
 Study Desgin Issues for FIH
Components of Pre-Clinical
Drug Development
IND,IMPD,CTA Filled
MAA,NDA,BLA Filled

6. Product A
• Feature 1
• Feature 2
• Feature 3
Product B
• Feature 1
• Feature 2
• Feature 3
 Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics
(what the drug does to the body) (PD), pharmacokinetics (what the body does to the drug) (PK), ADME, and toxicology testing.
This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans.
Medical devices that do not have drug attached will not undergo these additional tests and may go directly to good laboratory
practices (GLP) testing for safety of the device and its components. Some medical devices will also undergo biocompatibility
testing which helps to show whether a component of the device or all components are sustainable in a living model. Most
preclinical studies must adhere to GLPs(Subpart A to K) in ICH Guidelines to be acceptable for submission to regulatory agencies
such as the Food & Drug Administration in the United States.
Typically, both in vitro and in vivo tests will be performed. Studies of drug toxicity include which organs are targeted by that drug,
as well as if there are any long-term carcinogenic effects or toxic effects causing illness.
Nowadays Insilco Screening are also used with the aid of AL and ML tools to enhance the predictions and accuracy.

7. CTD Pyramid
The CTDs are the common technical Document which are
Regulated by the ICH to maintain the uniform pre-clinical
studies over the globe to promote public health.

8. THANKYOU!