Dossier, Impd and Ib

Deepak Gupta
M.Pharm
Jamia Hamdard

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Introduction
• Dossier is a collection or file of documents that
contains all the technical data of pharmaceutical
product i.e. dosages forms to be approved
/registered /marketed in a country.

•It is most commonly called as Registration dossier.

•In U.S : New drug application (NDA).

• In E.U: Marketing Authorization Application (
MAA).

•Dossier is a key tool to simplify and secure
document management.

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•It provides data that the drug has quality, efficacy
and safety properties suitable for the intended use,
additional administrative documents, samples of
finished product or related substances and reagents
necessary to perform analyzes of finished product.

•Therefore, they are the vehicle in a country through
which drug sponsors formally propose that the
Regulatory Agencies approve a new pharmaceutical
for sale and marketing.

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Investigation of Medicinal Products
Dossier (IMPD)
•IMPD is one of several pieces of Investigational
Medicinal Product (IMP) related data required
whenever the performance of a clinical trial is
intended in one or more EU Member States.

•The IMPD is the basis for approval of clinical trials
by the competent authorities in the EU.

• It includes summaries of information related to the
quality, manufacture and control of the
investigational medicinal product, data from non-
clinical studies and from its clinical use.

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•IMPD gives information related to the quality of
any IMP (i.e. including reference product and
placebo), manufacture and control of the IMP &
data from non -clinical studies and from its clinical
use.

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IMPD follow the structure of a CTD (Module 3)
The IMP dossier required will depend on many
factors including:
► risk aspects
► nature of the product
► state of development
► patient population
► nature and severity of the illness
► type and duration of the clinical trial

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Organization of NDA Dossiers
•Module 2 to module 5 of the NDA dossier is
compiled in accordance with CTD.

•Module 1 is region specific & module 2,3,4 & 5 are
common to all regions of CTD.

•IMPD is related with module 3 : document of
quality of CTD and M 4 Q of ICH guidelines which
contains :

•Section S – Drug substance

•Section P – Drug product

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•Section A – appendices

•Section R – any regional information e.g. executed
batch records ( USA only) & process validation
scheme for the drug product (EU only )

•Section C – contains any literature references

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Common Technical Document(CTD)
Module 1: Regional administrative information &
prescribing information

Module 2: CTD summaries(Quality overall
summary, Non-clinical overview, Non-clinical
summary, Clinical summary, Clinical overview)

Module 3: Document of quality

Module 4: Non-clinical study reports

Module 5 :Clinical study reports

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CTD TRIANGLE

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Contents of IMPD

•Table of contents

•List of Figures

•List of Tables

1. Introduction

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2.1 CHEMICAL PHARMACEUTICAL DATA

2.1.S DRUG SUBSTANCE

2.1.S.1 General Information:

2.1.S.1.1 Nomenclature
2.1.S.1.2 Structure
2.1.S.1.3 General Properties

2.1.S.2 Manufacture:

2.1.S.2.1 Manufacturer(s)
2.1.S.2.2 Description of Manufacturing Process and Process
2.1.S.2.3 Control of Materials
2.1.S.2.4 Controls of Critical Steps and Intermediates
2.1.S.2.5 Process validation and/or Evaluation
2.1.S.2.6 Manufacturing Process Development

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Investigator Brochure (IB)
•It is a compilation of the clinical and nonclinical
data on the investigational products which is
relevant to the study of the investigational product
in human subjects.

•The IB presents ,in summary form ,the key
nonclinical (safety),clinical, and CMC( quality) data
that support the proposed clinical trial.

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Aim of Investigator’s Brochure(IB)

• To provide the investigator with a clear
understanding of the possible risks and adverse
reactions & precautions that may be required.

• To provide information on Summary of Data and
Guidance for the Investigator.

•To document that relevant and current scientific
information about the investigational product has
been provided to the investigator.

•To provide information in simple & concise
manner.

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Contents of Investigator’s Brochure
•Physical,chemical,pharmaceutical,pharmacological,
toxicological,pharmacokinetic,metabolic & clinical
information available about the investigator’s
product.

1. Table of Contents

2.Introduction

3. Physical,Chemical, and Pharmaceutical Properties
and Formulation parameters

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4. Non-clinical Studies:

(a) Non-clinical Pharmacological
(Pharmacodynamics)

(b) Pharmacokinetics and Product Metabolism in
animals

(c) Toxicology

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5. Effects in Humans:

(a) Pharmacokinetics and Product Metabolism in
Humans

(b) Safety and Efficacy

(c) Regulatory & Post-marketing Experiences

6.Summary of Data & Guidance for the Investigator

7. Bibliography

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