How does difference in medical practice in Japan and the rest of the world effect drug development?
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How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics Mitsukuni Murasaki (Institute of CNS Pharmacology). Use of placebo. Antidepressants (1). Antidepressants (2).

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Slide1 l.jpg

How does difference in medical practice in Japan and the rest of the world effect drug development?

_ in the field of antidepressants _

and antipsychotics

Mitsukuni Murasaki

(Institute of CNS Pharmacology)


Antidepressants 1 l.jpg

Use of placebo rest of the world effect drug development?

Antidepressants (1)


Antidepressants 2 l.jpg
Antidepressants (2) rest of the world effect drug development?

Bridging study   -possible in Japan-

・same protocol

・same subject group

・same drug therapy

assessment of diagnostic criteria

DSM-Ⅳ

ICD-10

assessment of efficacy criteria

CGI

HAM-D

MADRS

Training for inter-rater reliability


Antidepressants 3 l.jpg
Antidepressants (3) rest of the world effect drug development?

Phase Ⅰstudy

Phase Ⅱa study

Phase Ⅱb study

Phase Ⅲ study

two comparative trials

TCA

trazodon → SSRI

SNRI

Long-term study


Antipsychotics 1 l.jpg

Use of placebo rest of the world effect drug development?

Antipsychotics (1)

Schizophrenia-Progressive and irreversible

the earlier, the better


Antipsychotics 2 l.jpg
Antipsychotics (2) rest of the world effect drug development?

Bridging study (1) -difficult in Japan-

assessment of diagnostic criteria

DSM-Ⅳ

ICD-10 paranoid

disorganized (hebephrenic)

schizo - affective

assessment of efficacy criteria

CGI

BPRS

PANSS

assessment of adverse events

EPS DIEPS

Simpson – Angus

Akathisia Barnes

Training for inter-rater reliability


Antipsychotics 3 l.jpg
Antipsychotics (3) rest of the world effect drug development?

Bridging study (2)

protocol

subject group

acute/acute exacerbation USA

chronic Japan

method for drug therapy

mono therapy USA

combination therapy Japan


Antipsychotics 4 l.jpg
Antipsychotics (4) rest of the world effect drug development?

Phase Ⅰstudy

Phase Ⅱa study

Phase Ⅱb study

Phase Ⅲ study

two comparative trials in Japan

haloperidol

mosapramine → atypicals

(risperidone)

Long-term study


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