ix. Signature of sponsor

b. Table of contents

c. Investigators brochure

d. Study protocol

e. Investigator facilities and IRB data

f. Chemistry manufacturing and control data

g. Previous human experience

9.2 INVESTIGATOR'S BROCHURE (IB)

It is a compilation of the clinical and non-clinical data on the investigational product

that is relevant to the study of the product in human subjects. The main purpose of an

investigator's brochure is to provide information to the investigator. It also enables

the investigator to understand the trial and make benefit/risk assessment of the

investigational product by own. The investigator’s brochure is edited by a medically

qualified person. The information included in the investigational brochure contains

(Fig. 9.3).

i. Dose

ii. Dose frequency

iii. Method of administration

iv. Safety monitoring procedure

A typical investigator’s brochure consists of:

• Contents of IB

• Title page

Fig. 9.2: Information attached with IND application

132 Industrial Pharmacy II

• Sponsor’s name

• The identity of each investigational product

• The release date

• Confidentiality statement

• Table of contents

• Summary

• Physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic,

metabolic and clinical information available of investigational product

• Introduction

• Chemical name

• Active ingredients

• Therapeutic/diagnostic indications

• Pharmacological class

• Description of investigational product

• Physical, chemical, pharmaceutical properties of investigational product

• Storage and handling of investigational product

• Any structural similarity with another compound

• Non-clinical study data

• Non-clinical pharmacology

• Pharmacokinetics and product metabolism in animals

• Toxicology

• Known effects in humans

• Summary of data and guidance for the investigator

9.3 NEW DRUG APPLICATION (NDA)

The application through which drug sponsors propose the approval of a new drug

product; for marketing in front of regulatory authority. It includes all clinical and

non-clinical data (Fig. 9.4).

According to FDA “The documentation required in an NDA is supposed to tell the

drug's whole story, including what happened during the clinical tests, what the

ingredients of the drug are, the results of the animal studies, how the drug behaves in

the body, and how it is manufactured, processed and packaged”.

The NDA provides enough information to FDA by which they can be easily established:

i. Safety of drug ii. Effectiveness of drug iii. Benefit–risk ratio

iv. Appropriateness of package insert v. Compliance with GMP

Fig. 9.3: Describing the importance of investigator's brochure

INDA and NDA 133