Slide1 l.jpg
This presentation is the property of its rightful owner.
Sponsored Links
1 / 8

How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics PowerPoint PPT Presentation


  • 49 Views
  • Uploaded on
  • Presentation posted in: General

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).

Download Presentation

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

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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

Antidepressants (1)


Antidepressants 2 l.jpg

Antidepressants (2)

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)

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

Antipsychotics (1)

Schizophrenia-Progressive and irreversible

the earlier, the better


Antipsychotics 2 l.jpg

Antipsychotics (2)

Bridging study (1)-difficult in Japan-

assessment of diagnostic criteria

DSM-Ⅳ

ICD-10paranoid

disorganized (hebephrenic)

schizo - affective

assessment of efficacy criteria

CGI

BPRS

PANSS

assessment of adverse events

EPSDIEPS

Simpson – Angus

AkathisiaBarnes

Training for inter-rater reliability


Antipsychotics 3 l.jpg

Antipsychotics (3)

Bridging study (2)

protocol

subject group

acute/acute exacerbationUSA

chronicJapan

method for drug therapy

mono therapyUSA

combination therapyJapan


Antipsychotics 4 l.jpg

Antipsychotics (4)

Phase Ⅰstudy

Phase Ⅱa study

Phase Ⅱb study

Phase Ⅲ study

two comparative trials in Japan

haloperidol

mosapramine → atypicals

(risperidone)

Long-term study


  • Login