<Invented name>
D80 AR - Clinical – rev.10/09
1/30
<Co->Rapporteur
DRAFT
Day 80 Critical Assessment Report
CLINICAL
<Invented Name>
<(Active Substance)>
EMEA/H/C/{nnnn}/{nnn}/{nnn}
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- GUIDANCE DOCUMENT -
<Invented name>
D80 AR - Clinical – rev.10/09
2/30
TABLE OF CONTENTS
I.
INTRODUCTION.......................................................................................................................... 5
I.1
Type of Application and aspects on development ....................................................................... 5
I.2
GCP aspects .................................................................................................................................... 6
I.3
Orphan Medicinal Products .......................................................................................................... 7
II.
CLINICAL PHARMACOLOGY ................................................................................................. 8
II.1
Pharmacokinetics (CTD modules 2.7.2, 5.3.1, 5.3.2, 5.3.3 and 5.3.4)......................................... 8
II.1.1 Introduction .................................................................................................................................... 8
II.1.2 Methods ........................................................................................................................................... 8
II.1.3 Absorption....................................................................................................................................... 9
II.1.4 Distribution ..................................................................................................................................... 9
II.1.5 Elimination...................................................................................................................................... 9
II.1.6