I

CHAPTER 6 RES ULI AND DISC USS ION

le of con ten t-
1.2 Tab
- Sr. CON TEN T

- I.I Cov erin g letter

- 1.2 Table Con tents of Mod ule I to 3

1.3 Application form

1.4 Agency Agr eem ent

1.5 Certificate of Pharmaceutical Product

1.6 Certificate of Suitability (CEP), if Applicable

1.7 Product information

1.7. l Summary of product characteristics

1.7.2 Labeling

1.7.3 Product information leaflet (PI)

l.7.4 Patient information leaflet (PU )

UMENT (CT D) SUM MA RIE S

MODULE 2: COM MO N TECHNICAL DOC
~

2. I CTD table of contents (Module 2-5)

-- 2.2 CTD introduction
r--
S-PD)
2.3 Quality overall summary-product dossier (QO
1-- -
2.3.S
Drug substance (S)

Dact asaheb B Page 46

alpan de College of Phar macy . Besa, Nagpur
 RESULI AND DISCUSSION
CHAPTER 6
--- General information
2J.S.I
L- --- Manufacture
2J.S.2
i--- Characterization
2J.S.3

- 2.3.S.4
Control of API

Reference standards or materials

...-
2.3.S.5

- 2J.S.6 Container closure system

2.3.S.7 Stability

- 2.3.P Finished pharmaceutical produc

t

drug product
2.3.P.I Description and composition of the

2.3.P.2 Phannaceutical development

2.3.P.3 Manufacture

2.3.P.4 Control of excipients

2.3.P.5 Control of the drug product

2.3 .P.6 Reference standards or materials

2.3.P.7 Container closure system

2.3.P.8 Stability

2.3.A Appendices

2.3.A.I Facilities and equipments

2.3.A.2 Adventitious agents safety evaluation

2.3.AJ Novel excipients

~

2.3.R Regional information

-
D cy,Besa, Nag pur Page 47
adasaheb Balpande College of Pharma
 RESULI AND DISCUSSION
CHAPTER 6

Production documentation
2.J.R.I
.......-
2.J.R.l.l Executed production documents

Master production documents

~

2.3.R. l .2

tion information
Analytical procedures and valida
~

2.3.R.2

- Non clinical overview

2.4
strategy
2.4.1 Overview of the nonclinical testing

2.4.2 Pharmacology

2.4.3 Pharmacokinetics

2.4.4 Toxicology

ns
2.4.5 Integrated overview and conclusio

2.4.6 List of literature references

2.5 Clinical overview

2.5.1 Product development rationale

2.5.2 Overview of biopharmaceutics

y
2.5.3 Overview of clinical pharmacolog

2.5.4 Overview of efficacy

2.5.5 Overview of safety

2.5.6 Benefits and risks conclusions

2.5.7 Literature references

2.6 Non clinical summary

-
rmacy. Bes a, Nagpur Page 48
Dadasaheb Balpande College of Pha
a
RESULI AND DISCUSSION
CHAPTER 6
-
Summary of phannacological properties
~

2.6.1 -
2.6.2 Summary of phannacokinetics properties

- Summary of toxicology
2.6.3

2.7 Clinical summary

2.7.1 Summary of bio-phannaceutics

2.7.2 Summary of clinical phannacology

2.7.3 Summary of clinical efficacy

2.7.4 Summary of clinical safety

MODULE 3: QUALITY

3.1 Table of contents

3.2 Body of data

3.2.S Drug substance

3.2.S.1 General information

3.2.S. l. I Nomenclature

3.2.S. I .2 Structure

3.2.S. I .3 General properties

3.2.S.2 Manufacture

3.2.S.2. I Manufacturer(s)

process controls
3.2.S.2.2 Description of manufacturing process and

3.2.S.2.3 Control of materials

esa, Nagpur
Dadasaheb Balpande College of Pharmacy.B Page 49
CHAPTER6 ,A\ ~N11[D DI SC USS ION
iiiii iiiii iiiii iiiiiiiiiiiiiiiiiiiiiiiii iiiiiiiiiiiiiii;;;;;=~R~E~S~U~LII
~-~ ~iii iiiii iiiii iiiii iiiii iiiii iiiii

3.2 .S.2.4 Controls of critical steps an d .intermediates

.
Process validation and/or ev a1uat,on
3.2.S.2.5

3.2.S.2.6 Manufacturing process devel opment

3.2.S.3 Characterization

t .f
3.2.S.3 . I Elucidation of structure and other cha rac ens 1cs
3.2.S.3.2 Impurities

3.2.S.4 Control of the API

3.2 .S.4 . I Specification

3.2.S.4.2 Analytical procedures

3.2.S.4.3 Validation of analytical procedures
3.2.S.4.4 Batch analyses

3.2.S.4.5 Justification of specification

3.2.S.5 Reference standards or materials

3.2.S.6 Container closure system

3.2.S.7 Stability

3.2.S.7. l Stability summary and conclusions

stability commitment
3.2.S.7.2 Post-approval stability protocol and

3.2.S.7.3 Stability data

aceutical product (FPP))
3.2.P Drug product (or finished pharm

drug product
3.2 .P.1 Description and composition of the

3.2.P.2 Pharmaceutical development

3.2.P.2. I Components of the FPP

3.2 .P.2. I. I Active pharmaceutical ingredient

3.2.P.2. I.2 Excipients

3.2.P.2.2 Finished pharmaceutical product

Page 50
rmacy, Besa, Nagpur
Dadasaheb Balpande Co llege of Pha
•
N
RESULI AND DISCUSSIO

-
CHAPTER 6

'T.f.P.2.2. I Fonnulation development

Overages
JJ .P .2 .2 .2 ical properties
'J,2.P.2.2.3 Physicochemical and biolog

lopment
J.2.P.2.3 Manufacturing process deve

31 .P.2.4 Container closure system

3.2.P .2.5 Microbiological attributes

3.2.P.2.6 Compatibility

3.2.P.3 Manufacture

3. 2.P.3.I Manufacturer(s)

3.2.P.3.2 Batch formula

process and process controls
3.2.P.3.3 Description of manufacturing
intermediates
3.2.P.3.4 Controls of critical steps and
aluation
~3.2.P.3.5 Process validation and/or ev

3.2 .P.4 Control of excipients

3.2.P.4.I Specification

3.2.P.4.2 Analytical procedures

ients
cedures and COA'S of excip
3.2.P.4.3 Validation of analytical pro

ns
3.2.P.4.4 Justification of specificatio
al origin
3.2.P.4.5 Excipients of human or anim

3.2.P.4.6 Novel excipients

3.2.P.5 Control of FPP

3.2.P.5.I Specification(s)

3.2.P.5.2 Analytical procedures

cedures
3.2.P.5.3 Validation of analytical pro

3.2.P.5.4 Batch analyses

es
3.2 .P.5.5 Characterization of impuriti
3.2 .P.5.6 Justification of specificatio
n(s)
-
7' -Z 37-,_
'
'
'

r ,, ' Page 51
e of Pharmacy, Besa, Nagpu
Dadasaheb Balpande Colleg .)
-.
-..r;/
cHAPTER6 RESULI AND DISCUSSION

3.2.P.6 Reference standards or materials

J.2.P.7 Container closure system

-
ORTS
MODULE 4: NONCLINICAL STUDY REP

-4.1 Table of contents

4.2 Study reports

4.2.I Pharmacology

4.2.1.l Primary pharmacodynamics

4.2.1.2 Secondary pharmacodynamics

4.2.1.3 Safety pharmacology

4.2.1.4 Pharmacodynamic interactions

4.2.2 Pharmacokinetics

4.2.2.1 Analytical methods and validation reports

4.2.2.2 Absorption

4.2.2.3 Distribution

4.2.2.4 Metabolism

4.2.2.5 Excretion

4.2.2.6 Pharmacokinetic interactions (non-clinical)

4.2.2.7 Other pharmacokinetic studies

4.2.3 Toxicology
4.2.3. I Single-dose toxicity

4.2.3.2 Repeat-dose toxicity

evaluation)
4.2.3 .3 Genotoxicity (in vitro, in vitro, toxic kinetics
studies)
4.2.3.4 Carcinogenicity (long, short- or medium-term

4.2.3.5 Reproductive and developmental toxicity

~

4.2.3.6 Local tolerance

a, Nagpur Page 52
Dadasaheb Balpande College of Pharmacy,Bes
bl

RESULI AND DISCUSSION

c llAPTER 6
---
t 2.3-7 Other toxicity studies

i--:--
.u Literature references

--- MODULE 5 : CLINICAL STUDY REPORTS

S.l Table of contents

S.2
Tabular listing of clinical studies

5.3 Clinical study reports

5.3.1
Reports of bio-pharmaceutical studies (bio-availabi Iity study reports,
comparative bio-availability and bio-equivalence study reports ,in
vitro and in vivo correlation study report, reports of bio-analytical and
analytical methods)

5.3.2
Reports of studies pertinent to pharmaco-kinetics using human bio-
materials

5.3.3
Reports of human pharmaco-kinetic studies
5.3.4
Reports of human pharmaco-dynamic studies
5.3.5
Reports of efficacy and safety studies

5.3.6
Reports of post-marketing experience
5.3.7
Case reports forms and individual patient listings
5.4
Literature references