Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
dose not exceed<strong>in</strong>g 1/100 of the<br />
dose express<strong>in</strong>g pharmacological<br />
effects or a dose of 100 µg/human,<br />
whichever is smaller, is adm<strong>in</strong>istered<br />
once to healthy subjects. The<br />
range of application is ma<strong>in</strong>ly low<br />
molecular weight compounds.<br />
3) Considerations for Individual Cl<strong>in</strong>ical<br />
Studies<br />
The follow<strong>in</strong>g important pr<strong>in</strong>ciples<br />
should be followed <strong>in</strong> plann<strong>in</strong>g the<br />
objectives, design, conduct, analysis <strong>and</strong><br />
report<strong>in</strong>g of a cl<strong>in</strong>ical study. Each item<br />
from the objectives to report<strong>in</strong>g should be<br />
def<strong>in</strong>ed <strong>in</strong> a written protocol before the<br />
study starts.<br />
3.1) Objectives<br />
The objective(s) of the study should be<br />
clearly stated. They may <strong>in</strong>clude<br />
exploratory or confirmatory<br />
characterization of the safety <strong>and</strong>/or<br />
efficacy <strong>and</strong>/or assessment of<br />
pharmacological, physiological or<br />
biochemical effects.<br />
3.2) Design<br />
The appropriate study design should<br />
be chosen to provide the desired<br />
<strong>in</strong>formation <strong>in</strong> consideration of the<br />
follow<strong>in</strong>g po<strong>in</strong>ts by referr<strong>in</strong>g to relevant<br />
cl<strong>in</strong>ical guidel<strong>in</strong>es:<br />
(1) Selection of subjects.<br />
<strong>Pharmaceutical</strong> <strong>Regulations</strong> <strong>in</strong> <strong>Japan</strong>:<br />
3.3) Conduct<br />
(2) Selection of control group.<br />
(3) Number of subjects.<br />
(4) Safety <strong>and</strong> efficacy variables.<br />
(5) Methods to m<strong>in</strong>imize bias<br />
(r<strong>and</strong>omization, bl<strong>in</strong>d<strong>in</strong>g, <strong>and</strong><br />
compliance).<br />
The study should be conducted<br />
accord<strong>in</strong>g to the pr<strong>in</strong>ciples described <strong>in</strong><br />
the General Considerations for Cl<strong>in</strong>ical<br />
Studies or <strong>in</strong> accordance with other<br />
pert<strong>in</strong>ent elements outl<strong>in</strong>ed <strong>in</strong> the GCP or<br />
other guidel<strong>in</strong>es related to cl<strong>in</strong>ical studies.<br />
Adherence to the study protocol is<br />
essential.<br />
3.4) Analysis<br />
The study protocol should cite a<br />
specified analysis plan that is appropriate<br />
for the objectives <strong>and</strong> design of the study.<br />
Methods of analysis of the primary<br />
endpo<strong>in</strong>ts <strong>and</strong> surrogate endpo<strong>in</strong>ts should<br />
be <strong>in</strong>cluded <strong>in</strong> the protocol. The results<br />
of the cl<strong>in</strong>ical study should be analyzed <strong>in</strong><br />
accordance with the plan prospectively<br />
stated <strong>in</strong> the protocol.<br />
3.5) Report<strong>in</strong>g<br />
Cl<strong>in</strong>ical study reports should be<br />
appropriately prepared <strong>in</strong> accordance with<br />
the Structure <strong>and</strong> Content of Cl<strong>in</strong>ical<br />
Study Reports (Notification No.335 of the<br />
Evaluation <strong>and</strong> Licens<strong>in</strong>g Division, PAB<br />
dated May 1, 1996: ICH E3).<br />
2011-3 - 90 -
Change language