Modul 1: Administrative Documents · Modul 1: Administrative Documents C001. VO-Template...
Transcript of Modul 1: Administrative Documents · Modul 1: Administrative Documents C001. VO-Template...
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VO-Template Deckblätter / pages de garde / cover sheets
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VM-ID: OS000_00_009dfe_VL - Vorlage / V1.0 / mra / ni / 01.01.2019 1
Swissmedic • Hallerstrasse 7 • 3012 Bern • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Modul 1: Administrative Documents
C001
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 2
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.0 Cover Letter
C002
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 3
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2 Forms
C003
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 4
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.2.26 GCP Inspections
C237
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 5
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.2.99 Other Forms
C027
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 6
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3 Annexes - Documents on Drug Product Quality
C051
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 7
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3.1 DMF Letter of Access
C052
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 8
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3.2 Ph. Eur. Certificate of Suitability for Active Substance
C053
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 9
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3.3 Ph. Eur. Certificate of Suitability for TSE
C054
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 10
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3.4 EMA Certificate for Plasma Master File (PMF)
C055
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 11
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.3.5 EMA Certificate for Vaccine Antigen Master File (VAMF)
C056
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 12
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.4 Annexes – Manufacturing
C057
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 13
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.4.1 GMP Certificate or Other GMP Documents
C058
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 14
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.4.2 Documentation Concerning Manufacturing Authorisation
C059
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 15
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.4.3 Complete Manufacturing Information with Flow Chart
C060
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 16
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.4.4 Confirmation on GMP Conformity
C061
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 17
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.5 Annexes – Others
C062
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 18
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.5.1 Comparison of Approved Information for Professionals with EU SmPC (for PSURs)
C063
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 19
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.2.5.2 Company Core Data Sheet (for PSURs)
C064
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 20
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.3 Product Information and Packaging Material
C029
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 21
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.3.1 Information for Professionals
C030
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 22
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.3.2 Information for Patients
C031
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 23
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.3.3 Packaging Material
C032
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VO-Template Deckblätter / pages de garde / cover sheets
CTD
QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 24
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.3.4 Information for Professionals From Other Countries
C033
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VO-Template Deckblätter / pages de garde / cover sheets
CTD
QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 25
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.4 Information About the Expert
C034
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 26
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.4.1 Quality
C035
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 27
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.4.2 Nonclinical
C036
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 28
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.4.3 Clinical
C037
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 29
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.5 Data of Bioavailability Studies
C038
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 30
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.6 Environmental Risk Assessment
C039
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 31
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7 Decision of Foreign Authorities
C040
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 32
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.1 Responses to LoQ
C041
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 33
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.2 Assessment Report
C042
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 34
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.3 EU Decision
C043
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 35
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.4 FDA Decision
C044
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 36
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.5 Decision of Other Foreign Authorities
C045
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 37
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.6 Paragraph 13 Additional Documentation
C046
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 38
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.7.6 Article 13 Additional Documentation
CC46
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 39
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.8 Information Relating to Pharmacovigilance
C047
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 40
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.8.1 Pharmacovigilance System
C048
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 41
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.8.2 Risk Management System
C049
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 42
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.9 Fast Track Status Decision
CA65
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 43
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.10 Information Relating to Paediatrics
C050
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 44
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.11 Orphan Drug Status Decision
CB65
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 45
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1.12 Art 14 Sec 1 Let abis-quater TPA
C238
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 46
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Additional Information
C065
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 47
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Responses to Swissmedic LoQ
C066
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 48
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Modul 2: Common Technical Document Summaries
C068
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 49
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.1 Common Technical Document Table of Contents (Modules 2-5)
C069
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 50
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.2 CTD Introduction
C070
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 51
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.3 Quality Overall Summary
C071
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 52
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.3 Introduction
C072
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 53
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.3.S Drug Substance
C073
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VO-Template Deckblätter / pages de garde / cover sheets
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QM-Ident: OS000_00_005dfe_VL / V1.0 / wkn / wja / 01.01.2019 54
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2.3.P Drug Product
C074
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2.3.A Appendices
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2.3.R Regional Information
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2.4 Nonclinical Overview
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2.5 Clinical Overview
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2.6 Nonclinical Written and Tabulated Summaries
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2.6.1 Introduction
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2.6.2 Pharmacology Tabulated Summaries
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2.6.3 Pharmacology Written Summaries
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2.6.4 Pharmacokinetics Tabulated Summaries
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2.6.5 Pharmacokinetics Written Summaries
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2.6.6 Toxicology Tabulated Summaries
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2.6.7 Toxicology Written Summaries
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2.7 Clinical Summary
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2.7.1 Biopharmaceutic Studies and Associated Analytical Methods
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2.7.2 Clinical Pharmacology Studies
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2.7.3 Clinical Efficacy
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2.7.4 Clinical Safety
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2.7.5 Literature References
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2.7.6 Synopses of Individual Studies
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Modul 3: Quality
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3.1 Table of Contents of Module 3
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3.2 Body of Data
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3.2.S Drug Substance
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3.2.S.1 General Information
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3.2.S.11 Nomenclature
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3.2.S.12 Structure
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3.2.S.13 General Properties
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3.2.S.2 Manufacture
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3.2.S.2.1 Manufacturer(s)
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3.2.S.2.2 Description of Manufacturing Process and Process Controls
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3.2.S.2.3 Control of Materials
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3.2.S.2.4 Controls of Critical Steps and Intermediates
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3.2.S.2.5 Process Validation and/or Evaluation
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3.2.S.2.6 Manufacturing Process Development
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3.2.S.3 Characterisation
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3.2.S.3.1 Elucidation of Structure and Other Characteristics
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3.2.S.3.2 Impurities
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3.2.S.4 Control of Drug Substance
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3.2.S.4.1 Specification
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3.2.S.4.2 Analytical Procedures
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3.2.S.4.3 Validation of Analytical Procedures
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3.2.S.4.4 Batch Analyses
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3.2.S.4.5 Justification of Specification
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3.2.S.5 Reference Standards or Materials
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3.2.S.6 Container Closure System
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3.2.S.7 Stability
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3.2.S.7.1 Stability Summary and Conclusions
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3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment
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3.2.S.7.3 Stability Data
C123
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3.2.P Drug Product
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3.2.P.1 Description and Composition of the Drug Product
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3.2.P.2 Pharmaceutical Development
C126
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3.2.P.2.1 Components
C127
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3.2.P.2.2 Product
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3.2.P.2.3 Process
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3.2.P.2.4 Container
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3.2.P.2.5 Microbiology
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3.2.P.2.6 Compatibility
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3.2.P.3 Manufacture
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3.2.P.3.1 Manufacturer(s)
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3.2.P.3.2 Batch Formula
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3.2.P.3.3 Description of Manufacturing Process and Process Controls
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3.2.P.3.4 Controls of Critical Steps and Intermediates
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3.2.P.3.5 Process Validation and/or Evaluation
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3.2.P.4 Control of Exipients
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3.2.P.4.1 Specifications
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3.2.P.4.2 Analytical Procedures
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3.2.P.4.3 Validation of Analytical Procedures
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3.2.P.4.4 Justification of Specifications
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3.2.P.4.5 Excipients of Human or Animal Origin
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3.2.P.4.6 Novel Excipients
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3.2.P.5 Control of the Drug Product
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3.2.P.5.1 Specification(s)
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3.2.P.5.2 Analytical Procedures
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3.2.P.5.3 Validation of Analytical Procedures
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3.2.P.5.4 Batch Analyses
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3.2.P.5.5 Characterisation of Impurities
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3.2.P.5.6 Justification of Specifications
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3.2.P.6 Reference Standards or Materials
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3.2.P.7 Container Closure Systems
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3.2.P.8 Stability
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3.2.P.8.1 Stability Summary and Conclusion
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3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment
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3.2.P.8.3 Stability Data
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3.2.A Appendices
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3.2.R Regional Information
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3.3 Literature References
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Modul 4: Nonclinical Study Reports
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4.1 Table of Contents of Module 4
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4.2 Study Reports
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4.2.1 Pharmacology
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4.2.1.1 Primary Pharmacodynamics
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4.2.1.2 Secondary Pharmacodynamics
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4.2.1.3 Safety Pharmacology
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4.2.1.4 Pharmacodynamic Drug Interactions
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4.2.2 Pharmacokinetics
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4.2.2.1 Analytical Methods and Validation Reports
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4.2.2.2 Absorption
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4.2.2.3 Distribution
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4.2.2.4 Metabolism
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4.2.2.5 Excretion
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4.2.2.6 Pharmacokinetic Drug Interactions (Nonclinical)
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4.2.2.7 Other Pharmacokinetic Studies
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4.2.3 Toxicology
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4.2.3.1 Single-Dose Toxicity
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4.2.3.2 Repeat-Dose Toxicity
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4.2.3.3 Genotoxicity
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4.2.3.3.1 In Vitro
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4.2.3.3.2 In Vivo
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4.2.3.4 Carcinogenicity
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4.2.3.4.1 Long-Term Studies
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4.2.3.4.2 Short- or Medium-Term Studies
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4.2.3.4.3 Other Studies
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4.2.3.5 Reproductive and Developmental Toxicity
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4.2.3.5.1 Fertility and Early Embryonic Development
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4.2.3.5.2 Embryo-fetal Development
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4.2.3.5.3 Prenatal and Postnatal Development, Including Maternal Function
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4.2.3.5.4 Studies in which the Offspring (Juvenile Animals) Are Dosed and/or Further Evaluated
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4.2.3.6 Local Tolerance
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4.2.3.7 Other Toxicity Studies
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4.2.3.7.1 Antigenicity
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4.2.3.7.2 Immunotoxicity
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4.2.3.7.3 Mechanistic studies
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4.2.3.7.4 Dependence
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4.2.3.7.5 Metabolites
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4.2.3.7.6 Impurities
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4.2.3.7.7 Other
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4.3 Literature References
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Modul 5: Clinical Study Reports
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5.1 Table of Contents of Module 5
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5.2 Tabular Listing of All Clinical Studies
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5.3 Clinical Study Reports
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5.3.1 Reports of Biopharmaceutic Studies
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5.3.1.1 Bioavailability (BA) Study Reports
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5.3.1.2 Comparative BA and Bioequivalence (BE)
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5.3.1.3 In Vitro – In Vivo Correlation Study Reports
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5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
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5.3.2 Reports of Studies Pertinent to PK Using Human Biomaterials
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5.3.2.1 Plasma Protein Binding Study Reports
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5.3.2.2 Reports of Hepatic Metabolism and Drug
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5.3.2.3 Reports of Studies Using Other Human Biomaterials
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5.3.3 Reports of PK Studies
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5.3.3.1 Healthy Subject PK and Initial Tolerability
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5.3.3.2 Patient PK and Initial Tolerability Study
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5.3.3.3 Intrinsic Factor PK Study Reports
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5.3.3.4 Extrinsic Factor PK Study Reports
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5.3.3.5 Population PK Study Reports
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5.3.4 Reports of PD Studies
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