Legal group: The legal group main responsibility is to file a patent at the appropriate
time to protect the intellectual property right of drug developers. This group includes
lawyers and patent agents who have experience in filing the patent.
Others: This section comprises supporting staff that assists the other groups in
running their business smoothly and efficiently.
The success of any drug development team depends upon time management and
resource management which can be done by the following ways:
ii. Execute the plan appropriately
iii. Hire the people who want to get the project done
iv. Differentiate what is necessary and what is not
8.2 NON-CLINICAL DRUG DEVELOPMENT
A targeted drug has to go through from various studies such as non-clinical and clinical
studies. Non-clinical studies are also known as pre-clinical studies. It is a stage of
research that happens before clinical studies. During non-clinical studies important
drug safety data is collected. These studies are necessary before filing Investigational
New Drug (IND) application. Pre-clinical studies have an important place during whole
drug development process as shown in Fig. 8.1.
Objectives of Non-clinical Drug Development
The main objective of non-clinical study is to confirm that either the target drug is safe
for use in human or not. This is done by studying animal pharmacology and toxicology
The Need for Non-clinical Studies
Non-clinical studies are essential
i. To determine the lethal dose, toxic dose (like LD50, ED 50, etc.).
ii. To determine the pharmacological action of the target drug.
iii. It is necessary to submit the animal testing report during the IND application.
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