EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 1- ADMINISTRATIVE INFORMATION and PRESCRIBING INFORMATION

TR-1995

Bölüm I- DOSYA ÖZETİ

EU-1998

1.1

ComprehensIve Table of Content

I A

İdari Bilgiler

I A

1.2

Application Form

I A

1-13

I A

1.3

Summary of Product Characteristics, Labelling and Package Leaflet

I A

1-13

I B

1.3.1

Summary of Product Characteristics

I A

1-13

I B1

1.3.2

Labeling

I C

Ekler

1. Ürünün kalitatif ve kantitatif terkibi

2. Prospektüs, 5 adet

3. Orijinal firmadan yetki belgesi

4. GMP Sertifikası

5. Orijinal ülke satış fiyatı (ithal)

6. Minimum ihraç fiyatı (ithal)

7. Orijinal ambalaj ve prospektüs örneği (İthal/ Lisanslı)

I B2

1.3.3

Package Leaflet

I B2

1.3.4

Mock-ups and specimens

 

 
I B2

1.3.5

SPCs already approved in the Member States

 

 

I A

1.4

Information about Experts

 

 

I C

1.5

Specific requirements for different types of applications

 

 

 

1.5.1

Information for bibliographical applications

 

 

 

1.5.2

Information for abridges ‘generic’ applications

 

 

 

Annex I

Environmental risk assesment

 

 

III R

II H

Annex II

Orphan medicinal products- Demonstration of significant benefit

 

 

-

 


 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

Bölüm I- DOSYA ÖZETİ

EU-1998

2.1

Overall CTD Table of Contents of Modules 2, 3, 4, 5

 

 

I A

2.2

IntroductIon

 

 

I C

2.3

QualIty Overall Summary

I B

Kısa Ürün Bilgileri (KÜB)

I C1

2.3.S

DRUG SUBSTANCE

 

 

 

2.3.S.1

General Information

 

 

 

2.3.S.2

Manufacture

 

 

 

2.3.S.3

Characterisation

 

 

 

2.3.S.4

Control of Drug Substance

 

 

 

2.3.S.5

Referance Standards or Materials

 

 

 

2.3.S.6

Container Closure System

 

 

 

2.3.S.7

Stability

 

 

 

2.3.P

DRUG PRODUCT

I B1

Tıbbi Farmasötik ürünün adı

 

2.3.P.1

Description and Composition of the Drug Product

I B2

I B3

Kalitatif ve kantitatif terkibi,ekses belirtilir

Farmasötik Formu

 

 

2.3.P.2

Pharmaceutical Development

 

 

 

2.3.P.3

Manufacture

I B6.2

Üretimdeki temel proseslerin tanımı

 

2.3.P.4

Control of Excipients

I B6.1

Yardımcı maddelerin kalitatif ve kantitatif miktarı

 

2.3.P.5

Control of Drug Product

I B6.3

Bitmiş ürün spesifikasyonları

 

2.3.P.6

Referance Standards or Materials

 

 

 

2.3.P.7

Container Closure System

I B6.4

I B6.7

I B6.8

Geçimsizlik

Ambalajın türü ve yapısı

Kullanma Talimatı

 

2.3.P.8

Stability

I B6.5

Raf ömrü, rekonstitüsyon .......

 

2.3.A

APPENDICES

 

 

 

2.3.A.1

Facilities and Equipment

I B6.6

Özel muhafaza şartları 

 

2.3.A.2

Adventitious Agents Safety Evaluation

 

 

 

2.3.A.3

Novel Excipients

 

 

 

2.3.R

REGIONAL INFORMATION

I C

Ekler

 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

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CTD-

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MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

 

EU-1998

2.4

NonclInIcal OvervIew

 

 

I C2

2.4.1

Overview of the Nonclinical Testing Strategy

 

 

 

2.4.2

Pharmacology

 

 

 

2.4.3

Pharmacokinetics

 

 

 

2.4.4

Toxicology

 

 

 

2.4.5

Integrated Overview and Conclusions

 

 

 

2.4.6

List of Literature References

 

 

 

2.5

ClInIcal OvervIew

 

 

I C3

2.5.1

Product Development Rationale

 

 

 

2.5.2

Overview of Biopharmaceutics

 

 

 

2.5.3

Overview of Clinical Pharmacology

 

 

 

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

NonclınIcal Summary

 

 

I C2

2.6.1

Introduction

 

 

 

2.6.2

Pharmacology Written Summary

I B5

Farmakolojik Özellikler

I C2

2.6.2.1

Brief Summary

I B5.1

Farmakodinamik Özellikler

 

2.6.2.2

Primary Pharmacodynamics

 

 

 

2.6.2.3

Secondary Pharmacodynamics

 

 

 

2.6.2.4

Safety Pharmacology

 

 

 

2.6.2.5

Pharmacodynamic Drug Interactions

 

 

 

2.6.2.6

Discussion and Conclusions

 

 

 

2.6.2.7

Tables and Figures

 

 

 

2.6.3

Pharmacology Tabulated Summary

 

 

I C2

2.6.3.1

Pharmacology: Overview

 

 

 

2.6.3.2

Primary Pharmacodynamics (either here or included in text)

 

 

 

2.6.3.4

Safety Pharmacology

 

 

 

 


 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

 

EU-1998

2.6.3.3

Secondary Pharmacodynamics (either here or included in text)

 

 

 

2.6.3.5

Pharmacodynamic Drug Interactions (either here or included in text)

 

 

 

2.6.4

Pharmacokinetics Written Summary

I B5.2

Farmakokinetik bilgiler

I C2

2.6.4.1

Brief Summary

 

 

 

2.6.4.2

Methods of Analysis

 

 

 

2.6.4.3

Absorption

 

 

 

2.6.4.4

Distribution

 

 

 

2.6.4.5

Metabolism

 

 

 

2.6.4.6

Excretion

 

 

 

2.6.4.7

Pharmacokinetic Drug Interactions

 

 

 

2.6.4.8

Other Pharmacokinetic Studies

 

 

 

2.6.4.9

Discussion and Conclusion

 

 

 

2.6.4.10

Tables and Figures

 

 

 

2.6.5

Pharmacokinetics Tabulated Summary

 

 

I C2

2.6.5.1

Pharmacokinetics: Overview

 

 

 

2.6.5.2

Analytical Methods and Validation Reports (either here or included in text)

 

 

 

2.6.5.3

Pharmacokinetics: Absorption After a Single Dose

 

 

 

2.6.5.4

Pharmacokinetics: Absorption After a Repeated Dose

 

 

 

2.6.5.5

Pharmacokinetics: Organ Distribution

 

 

 

2.6.5.6

Pharmacokinetics: Plasma Protein Binding

 

 

 

2.6.5.7

Pharmacokinetics: Study in Pregnant or Nursing Animals

 

 

 

2.6.5.8

Pharmacokinetics: Other Distribution Study

 

 

 

2.6.5.9

Pharmacokinetics: Metabolism in Vivo

 

 

 

2.6.5.10

Pharmacokinetics: Metabolism in Vitro

 

 

 

2.6.5.11

Pharmacokinetics: Possible Metabolic Pathways

 

 

 

2.6.5.12

Pharmacokinetics: Induction/ Inhibition of Drug- Metabolising Enzymes

 

 

 

2.6.5.13

Pharmacokinetics: Excreation

 

 

 

2.6.5.14

Pharmacokinetics: Excreation into Bile

 

 

 

2.6.5.15

Pharmacokinetics: Drug- Drug Interactions

 

 

 

2.6.5.16

Pharmacokinetics: Other

 

 

 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

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2001

MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

 

EU-1998

2.6.6

Toxicology Written Summary

 

 

---

2.6.6.1

Brief Summary

 

 

 

2.6.6.2

Single-Dose Toxicity

 

 

 

2.6.6.3

Repeat-Dose Toxicity (including supportive toxicokinetics evalutaions)

 

 

 

2.6.6.4

Genotoxicity

 

 

 

2.6.6.5

Carcinogenicity (including supportive toxicokinetics evaluations)

 

 

 

2.6.6.6

Reproductive and Developmental Toxicity

(including range-finding studies and supportive toxicokinetics evaluations)

 

 

 

2.6.6.7

Studies in Juvenile Animals

 

 

 

2.6.6.8

Local Tolerance

 

 

 

2.6.6.9

Other Toxicity Studies (if available)

 

 

 

2.6.6.10

Discussion and Conclusions

 

 

 

2.6.6.11

Tables and Figures (either here or included in text)

 

 

 

2.6.7

Toxicology Tabulated Summary

 

 

I C2

2.6.7.1

Toxicology: Overview

 

 

 

2.6.7.2

Toxicokinetics: Overview of  Toxicokinetics Studies

 

 

 

2.6.7.3

Toxicokinetics: Overview of  Toxicokinetics Data

 

 

 

2.6.7.4

Toxicology: Drug Substance

 

 

 

2.6.7.5

Single-Dose Toxicity

 

 

 

2.6.7.6

Repeat-Dose Toxicity: Nonpivotal Studies

 

 

 

2.6.7.7

Repeat-Dose Toxicity: Pivotal Studies

 

 

 

2.6.7.8

Genotoxicity: In Vitro

 

 

 

2.6.7.9

Genotoxicity: In Vivo

 

 

 

2.6.7.10

Carcinogenicity

 

 

 

2.6.7.11

Reproductive and Developmental Toxicity: Nonpivotal Studies

 

 

 

2.6.7.12

Reproductive and Developmental Toxicity: Fertility and Early Embryonic Development to Implantation (Pivotal)

 

 

 

2.6.7.13

Reproductive and Developmental Toxicity: Effects on Embryo Fetal Development (Pivotal)

 

 

 

 

 

 

 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

 

EU-1998

2.6.7.14

Reproductive and Developmental Toxicity: Effects on  Pre- and Postnatal Development, Including Materrnal Function (Pivotal)

 

 

 

2.6.7.15

Studies in Juvenile Animals

 

 

 

2.6.7.16

Local Tolerance

 

 

 

2.6.7.17

Other Toxicity Studies

 

 

 

2.7

ClInIcal Summary

 

 

I C3

2.7.1

Summary of  Biopharmaceutics Studies and Associated Analytical Methods

 

 

I C3

2.7.1.1

Background and Overview

 

 

 

2.7.1.2

Summary of Results of Individual Studies

 

 

 

2.7.1.3

Comparison and Analyses of Results Across Studies

 

 

 

2.7.1.4

Appendix

 

 

 

2.7.2

Summary of  Clinical  Pharmacology Studies

 

 

I C3

2.7.2.1

Background and Overview

 

 

 

2.7.2.2

Summary of Results of Individual Studies

 

 

 

2.7.2.3

Comparison and Analyses of Results Across Studies

 

 

 

2.7.2.4

Special Studies

 

 

 

2.7.2.5

Appendix

 

 

 

2.7.3

Summary of  Clinical  Efficacy  (a separate document for each indication)

 

 

I C3

2.7.3.1

Background and Overview of Clinical Efficacy

 

 

 

2.7.3.2

Summary of Results of Individual Studies

 

 

 

2.7.3.3

Comparison and Analyses of Results Across Studies

 

 

 

2.7.3.3.1

Study Populations

 

 

 

2.7.3.3.2

Comparison of Efficacy Results of all Studies

 

 

 

2.7.3.3.3

Comparison of Results in Sub-populations

 

 

 

2.7.3.4

Analysis of Clinical Information Relevant to Dosing Recommendations

 

 

 

2.7.3.5

Persistence of Efficacy and/ or Tolerance Effects

 

 

 

2.7.3.6

Appendix

 

 

 

 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 2- COMMON TECHNICAL DOCUMENT SUMMARIES

TR-1995

 

EU-1998

2.7.4

Summary of  Clinical Safety

 

 

I C3

2.7.4.1

Exposure to the Drug

 

 

 

2.7.4.1.1

Overall Safety Evaluation Plan and Narratives of  Safety Studies

 

 

 

2.7.4.1.2

Overall Extent of Exposure

 

 

 

2.7.4.1.3

Demographic and Other Characteristics of Study Population

 

 

 

2.7.4.2

Adverse Events

I B4.8

İstenmeyen Etkiler (sıklık ve şiddet)

 

2.7.4.2.1

Analysis of Advers Events

 

 

 

2.7.4.2.1.1

Common Adverse Events

 

 

 

2.7.4.2.1.2

Deaths

 

 

 

2.7.4.2.1.3

Other Serious Adverse Events

 

 

 

2.7.4.2.1.4

Other Significant Adverse Events

 

 

 

2.7.4.2.1.5

Analysis of Adverse Events by Organ System or Syndrome

 

 

 

2.7.4.2.2

Narratives

 

 

 

2.7.4.3

Clinical Laboratory Evaluations

 

 

 

2.7.4.4

Vital Signs, Physical Findings, and Other Observations Related to Safety

 

 

 

2.7.4.5

Safety in Special Groups and Situations

 

 

 

2.7.4.5.1

Intrinsic Factors

 

 

 

2.7.4.5.2

Extrinsic Factors

 

 

 

2.7.4.5.3

Drug Interactions

I B4.5

Diğer ilaçlarla etkileşim ve diğer etkileşim türleri

 

2.7.4.5.4

Use in Pregnancy and Lactation

I B4.6

Gebelik ve laktasyonda kullanımı

 

2.7.4.5.5

Overdose

I B4.9

Doz aşımı

 

2.7.4.5.6

Drug Abuse

 

 

 

2.7.4.5.7

Withdrawal and Rebound

 

 

 

2.7.4.5.8

Effects on Ability to drive or Operate Machinery or Impairment of Mental Ability

I B4.7

Araç ve makine kullanmaya etkisi

 

2.7.4.6

Post-marketing Data

 

 

 

2.7.4.7

Appendix

 

 

 

2.7.5

Literature References

 

 

I C3

2.7.6

Synopses of Individual Studies

 

 

 


 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODUL 3- QUALITY

TR-1995

Bölüm II- KİMYASAL, FARMASÖTİK VE BİYOLOJİK BİLGİLER

EU-1998

3.1

MODULE 3 TABLE OF CONTENTS

 

 

---

3.2

BODY OF DATA

 

 

II

3.2.S

DRUG SUBSTANCE

 

 

 

3.2.S.1

General Information

II C1.2

Bilimsel Veriler

II C1.2

3.2.S.1.1

Nomenclature

II C1.2.1

İsimlendirme

II C1.2.1

3.2.S.1.2

Structure

II C1.2.2

Tanım

II C1.2.2

3.2.S.1.3

General Properties

II C1.2.5

A, B,C Kimyasal etkin maddeler için geliştirme kimyası

II C1.2.5

3.2.S.2

Manufacture

II C1.2.3

Üretim

II C1.2.3

3.2.S.2.1

Manufacturer (s)

II C1.2.3

Üretim

II C1.2.3

3.2.S.2.2

Description of manufacturing process and process controls

II C1.2.3

Üretim

II C1.2.3

3.2.S.2.3

Control of materials

II C1.2.4

Üretim sırasında kalite kontrolü

II C1.2.4

3.2.S.2.4

Control of critical steps and intermediates

II C1.2.4

Üretim sırasında kalite kontrolü

II C1.2.4

3.2.S.2.5

Process validation and/ or evaluation

 

 

----

3.2.S.2.6

Manufacturing process development

 

 

 

3.2.S.3

Characterization

 

 

 

3.2.S.3.1

Elucidation of structure and other characteristics

II C1.2.5

 A, B,C: Kimyasal etkin maddeler için geliştirme kimyası

II C1.2.5

3.2.S.3.2

Impurities

II C1.2.6

Safsızlıklar

II C1.2.6

3.2.S.4

Control of Drug Substance

II C1

Etkin Maddeler

II C1

3.2.S.4.1

Specification

II C1.1

Spesifikasyonlar ve rutin testler

II C1.1

3.2.S.4.2

Analytical procedures

II C1.1

Spesifikasyonlar ve rutin testler

II C1.1

3.2.S.4.3

Validation of analytical procedures

II C1.2.5

A,B,C: Kimyasal etkin maddeler için geliştirme kimyası

II C1.2.5

3.2.S.4.4

Batch Analyses

II C1.2.7

Seri Analizleri

II C1.2.7

3.2.S.4.5

Justification of specification

 

 

II C1.2.5

3.2.S.5

Reference Standards or Materials

II C1.2.5

 A, B,C: Kimyasal etkin maddeler için geliştirme kimyası

II C1.2.5

II C1.2.7

3.2.S.6

Container Closure System

II C.3

Ambalaj Malzemesi (Primer Ambalaj)

 

--

 

 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD  (ICH M4Q:CTD- Quality)

 

Bölüm II- KİMYASAL, FARMASÖTİK VE BİYOLOJİK BİLGİLER

 

CTD

MODUL 3- QUALITY

TR-1995

TURKISH MOH

EU-1998

3.2.S.7

Stability

II F

Stabilite

II F.1

3.2.S.7.1

Stability summary and conclusions

II F.1

Etkin maddelerin stabilite testleri

 

3.2.S.7.2

Post-approval stability protocol and stability commitment

 

 

 

3.2.S.7.3

Stability Data

II F.1

Stabilite

 

3.2.P

DRUG PRODUCT

 

 

 

3.2.P.1

Description and Composition of the Drug Product

 

 

II.A

3.2.P.2

Pharmaceutical Developmant

II.A.1

Terkib

II A.4

3.2.P.2.1

Components of the drug product

II.A.1

Müstahzarın Terkibi

II A.1

3.2.P.2.1.1

Drug substance

II.A.1

Etkin maddelerin adı, miktarı, fonksiyonu, ref

II A.1

3.2.P.2.1.2

Excipients

II.A.1

Yardımcı maddelerin adı, miktarı, fonksiyonu, ref

II A.1

3.2.P.2.2

Drug Product

 

 

 

3.2.P.2.2.1

Formulation Development

II A.3

II A.4

Müstahzarın Farmasötik Gelişimi

Klinik Araştırma Formülü (gerektiğinde)

II A.4

II A.3

3.2.P.2.2.2

Overages

 

 

 

3.2.P.2.2.3

Physicochemical and Biological Properties

 

 

 

3.2.P.2.3

Manufacturing Process Development

 

 

 

3.2.P.2.4

Container Closure System

II A.2

Ambalajın Tanımı

II A.2

3.2.P.2.5

Microbiological Attributes

 

 

 

3.2.P.2.6

Compatibility

 

 

 

3.2.P.3

Manufacture

II B

Üretim Metodu

II B

3.2.P.3.1

Manufactıurer (s)

 I A.6

Üretim yerinin adı, adresi, tel- fax numaraları

 I A

3.2.P.3.2

Batch formula

II B.1

İmalat Formülü

II B1

3.2.P.3.3

Description of manufacturing process and process controls

II B.2

II B.3

II B.4

İmalat İşlemi

İmalat Akış Şeması

İn-proses kontroller

II B2

3.2.P.3.4

Controls of critical steps and intermediates

II D

Ara Ürün Kontrol Testleri (gerekiyorsa)

II B2

3.2.P.3.5

Process validation and/ or evaluation

 

 
II B3

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODUL 3- QUALITY

TR-1995

Bölüm II- KİMYASAL, FARMASÖTİK VE BİYOLOJİK BİLGİLER

EU-1998

3.2.P.4

Control of Excipients

II C2

Diğer Maddeler

II C2

3.2.P.4.1

Spesifications

II C2.1

Spesifikasyonlar ve rutin testler

II C2.1

3.2.P.4.2

Analytical procedures

II C2.1

Spesifikasyonlar ve rutin testler

II C2.1

3.2.P.4.3

Validation of analytical procedures

 

Test Metod Validasyonları Yok

II C2.2

3.2.P.4.4

Justification of specification (s)

 

 

II C2.2

3.2.P.4.5

Excipients of Human or Animal Origin

 

 

-----

3.2.P.4.6

Novel excipients

II C2.2

Bilimsel veriler ..........

II C2.2.1

II C2.2.2

3.2.P.5

Control of Drug Product

II E

Bitmiş Ürün Kontrolleri

II E

3.2.P.5.1

Specification(s)

II E1.1

Ürün spesifikasyonları ve serbest bırakma testleri (üretim anında)

II E1.1

II F2

3.2.P.5.2

Analytical procedures

II E1.2

Kontrol metodları

II E1.2

3.2.P.5.3

Validation of analytical procedures

 

 

II E2.1

3.2.P.5.4

Batch analyses

II E2.2

Seri analizleri: Test edilen seriler, sonuçlar

II E2.2

3.2.P.5.5

Characterisation of impurities

 

 

-----

3.2.P.5.6

Justification of specification (s)

II E2.1

Bitmiş ürün kontrollerinde kullanılan rutin testlerin ve standardların seçimi hk.

II E2.1

3.2.P.6

Referance Standards or Materials

II E2.2

Seri analizleri: ref. std

II E2.2

3.2.P.7

Container Closure System

II C3

Ambalaj Malzemesi

II C3

3.2.P.8

Stability

II F

Stabilite

II F2

3.2.P.8.1

Stability summary and conclusion

II F2

Bitmiş ürünün stabilite testleri

II F2

3.2.P.8.2

Post-approval stability protocol and stability commitment

II F2

Devam eden stabilite çalışmaları

II F2

3.2.P.8.3

Stability Data

II F2

Stabilite verileri

----

3.2.A

APPENDICES

 

 

 

3.2.A.1

Facilities and Equipment

 

 

-----

3.2.A.2

Adventitious Agents Safety Evaluation

 

 

-----

3.2.A.3

Novel Excipients

II C2.2

Bilimsel veriler ..........

----

3.2.R

REGIONAL INFORMATION

 

 

-----

3.3

LITERATURE REFERENCES

 

 

II Q


 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 4- NONCLINICAL STUDY REPORTS

TR-1995

Bölüm III- TOKSİKOLOJİK VE FARMAKOLOJİK BİLGİLER

EU-1998

4.1

MODULE 4 TABLE OF CONTENTS

 

 

----

4.2

STUDY REPORTS

III

 

III

4.2.1

PHARMACOLOGY

III F

Farmakodinamik Bilgiler

III F

4.2.1.1

Primary pharmacodynamics

III F1

Önerilen endikasyonlara ilişkin farmakodinamik etkiler

III F1

4.2.1.2

Secondary pharmacodynamics

III F2

Genel farmakodinami

III F2

4.2.1.3

Safety pharmacology

III F2

Genel farmakodinami

III F2

4.2.1.4

Pharmacodynamic drug interactions (nonclinical)

III F3

İlaç etkileşimleri

III F3

4.2.2

PHARMACOKINETICS

III G

Farmakokinetik Bilgiler

III G

4.2.2.1

Analytical Methods and Validation Reports

III I

Yok

III Q

4.2.2.2

Absorption

III G1

III G2

Tek doz sonrası farmakokinetik

Mükerrer uygulamadan sonra farmakokinetik

III G1

III G2

4.2.2.3

Distribution

III G3

Normal ve gebe hayvanlarda dağılım (Örneğin otoradyografi)

III G3

4.2.2.4

Metabolism

III G4

Biyotransformasyon

III G4

4.2.2.5

Excreation

 

 

III G1

III G2

4.2.2.6

Pharmacokinetic drug interactions (nonclinical)

 

 

-----

4.2.2.7

Other pharmacokinetic studies

 

 

-----

4.2.3

TOXICOLOGY

III

1, 2, 3,4

III A

4.2.3.1

Single-dose toxicity

III A

Tek doz toksisitesi

III A1

4.2.3.2

Repeat-dose toxicity

III B

Mükerrer doz toksisitesi

III A2

4.2.3.3

Genotoxicity

III D

Mutajenik Potansiyel

III D

4.2.3.3.1

In vitro

III D1

Mutajenik Potansiyel

III D

4.2.3.3.2

In vivo (including supportive toxicokinetics evaluations)

III D2

Mutajenik Potansiyel

III D

 


 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 4- NONCLINICAL STUDY REPORTS

TR-1995

Bölüm III- TOKSİKOLOJİK VE FARMAKOLOJİK BİLGİLER

EU-

1998

4.2.3.4

Carcinogenicity (including supportive toxicokinetics evaluations)

III E

Onkojenik/ karsinojenik Potansiyel

III E

4.2.3.4.1

Long-term studies (in order by species; including range finding studies that can not appropriately be included under repeat dose toxicity or pharmacokinetics)

 

 

 

4.2.3.4.2

Short- or medium-term studies (including range finding studies that can not appropriately be included under repeat dose toxicity or pharmacokinetics)

 

 

 

4.2.3.4.3

Other studies

 

 

 

4.2.3.5

Reproductive and Developmental Toxicity (including range finding studies and supportive  toxicokinetics evaluations) (If modified study designs are used, the following sub-headings should be modified accordingly)

III C

Üreme Üstüne Çalışmalar

III B

III C

4.2.3.5.1

Fertility and early embryonic development

III C.1

Doğurganlık ve Genel Üremeye Etkisi

 

4.2.3.5.2

Embryo-fetal development

III C.2

Embriyo Toksisite

 

4.2.3.5.3

Prenatal and postnatal development, including maternal function

III C.3

Perinatal/postnatal Toksisite

 

4.2.3.5.4

Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

 

 

 

4.2.3.6

Local tolerance

III H

Lokal Tolerans (Toksisite) (Gereken Durumlarda)

III H

4.2.3.7

Other toxicity studies

III I

Başka bilgiler

III Q

4.2.3.7.1

Antigenicity

 

 

 

4.2.3.7.2

Immunotoxicity

 

 

 

4.2.3.7.3

Mechanistic studies (if not included elsewhere)

 

 

 

4.2.3.7.4

Dependence

 

 

 

4.2.3.7.5

Metabolites

 

 

 

4.2.3.7.6

Impurities

 

 

 

4.2.3.7.7

Other

 

 

 

4.3

Literature References

III I

 

III Q

 

 

                                                                                   


 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 5- CLINICAL STUDY REPORTS

TR-1995

Bölüm IV- KLİNİK DÖKÜMANTASYON

EU-

1998

5.1

MODULE 5 TABLE OF CONTENTS

 

 

-----

5.2

TABULAR LISTING OF ALL CLINICAL STUDIES

 

 

I C3

5.3

CLINICAL STUDY REPORTS

IV A

Klinik Farmakoloji

IV

5.3.1

Reports of Biopharmaceutic Studies

IV A2

Farmakokinetik

IV A2

5.3.1.1

Bioavailability (BA) Study Reports

IV A2

 

 

5.3.1.2

Comparative BA and Bioequivalence (BE) Study Reports

 

 

 

5.3.1.3

In Vitro- In Vivo Correlation Study Reports

 

 

 

5.3.1.4

Reports of Bioanalytical and Analytical Methods for Human Studies

 

 

 

5.3.2

Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials

 

 

IV A2

5.3.2.1

Plasma Protein Binding Study Reports

 

 

 

5.3.2.2

Reports Hepatic Metabolism and Drug Interaction Studies

 

 

 

5.3.2.3

Reports od Studies Using Other Human Biomaterials

 

 

 

5.3.3

Reports of human pharmacokinetics (PK) studies

 

 

IV A2

5.3.3.1

Healty Subject PK and Initial Tolerability Study Reports

 

 

 

5.3.3.2

Patient PK and Initial Tolerability Study Reports

 

 

 

5.3.3.3

Intrinsic Factor PK Study Reports

 

 

 

5.3.3.4

Ectrinsic Factor PK Study Reports

 

 

 

5.3.3.5

Population PK Study Reports

 

 

 

5.3.4

Reports of human pharmacodynamics (PD) studies

IV A1

Farmakodinamik

IV A1

5.3.4.1

Healty Subject PD and PK/PD Study Reports

 

 

 

5.3.4.2

Patient PD and PK/PD Study Reports

 

 

 

 


 

 

 

EU-CTD (NTA, Vol. 2B, Ed. 2001), US-CTD (ICH M4Q: CTD- Quality)

 

TURKISH MOH

 

CTD-

2001

MODULE 5- CLINICAL STUDY REPORTS

TR-1995

Bölüm IV- KLİNİK DÖKÜMANTASYON

EU-

1998

 

 

IV B

Klinik Değerlendirme

IV B

5.3.5

Reports of efficacy and safety studies

IV B1

Klinik Denemeler

IV B1

5.3.5.1

Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication

IV B3

Yayınlanmış veya Yayınlanmamış Çalışmalar (1. dekilerden başka)

 

5.3.5.2

Study Reports of Uncontrolled Clinical Studies

IV B3

Yayınlanmış veya Yayınlanmamış Çalışmalar (1. dekilerden başka)

 

5.3.5.3

Reports of Analyses of Data from More than One Study

IV B3

Yayınlanmış veya Yayınlanmamış Çalışmalar (1. dekilerden başka)

 

5.3.5.4

Other Study Reports

IV B3

 

IV B3

5.3.6

Reports of Post-marketing Experience

IV B2

Pazarlama Sonrası Deneyim

IV B2

5.3.7

Case report forms and individual patient listings

IV B1.3

Tek tek hastalara ilişkin veriler

IV B1

5.4

Literature References

IV B3.2

Diğer başka bilgiler

IV B3

IV Q