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:

i. Plan and re-plan carefully

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

v. Have patience

124 Industrial Pharmacy II

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

testing.

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.

iv. To determine the pharmacokinetic properties of a drug.