how does difference in medical practice in japan and the rest of the world effect drug development?...

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)

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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)

Page 2: How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics

Antidepressants (1)

Use of placebo

in any stage PossibleUSA, CanadaScandinavian countries

three armsRecommended

European countries

Impossible Germany, Japan

randomized withdrawal study (relapse/recurrence)

Necessary Europe

Recommended

Japan

Antidepressants (2)

Bridging study 　　　－ possible in Japan －・ same protocol・ same subject group・ same drug therapy

assessment of diagnostic criteriaDSM-ⅣICD-10

assessment of efficacy criteriaCGIHAM-DMADRS

Training for inter-rater reliability

Page 4: How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics

Antidepressants (3)

Phase ⅠstudyPhase Ⅱa studyPhase Ⅱb studyPhase Ⅲ study　　　 two comparative trials

　 TCA　 trazodon → SSRI　　 SNRI

Long-term study

Page 5: How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics

Antipsychotics (1)

Use of placebo

Possible USA, Canada

ImpossibleEuropeJapan

Schizophrenia 　 - 　 Progressive and irreversible　　　　　　　　　　　　　 the earlier, the better

Page 6: How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics

Antipsychotics (2)

Bridging study (1) -difficult in Japan-assessment of diagnostic criteria

DSM-ⅣICD-10 paranoid

disorganized (hebephrenic)

schizo - affectiveassessment of efficacy criteria

CGIBPRSPANSS

assessment of adverse eventsEPS DIEPS

Simpson – AngusAkathisia Barnes

Training for inter-rater reliability

Page 7: How does difference in medical practice in Japan and the rest of the world effect drug development? _ in the field of antidepressants _ and antipsychotics

Antipsychotics (3)

Bridging study (2)

protocol

subject groupacute/acute exacerbation USAchronic Japan

method for drug therapymono therapy USAcombination therapy

Japan

Antipsychotics (4)

Phase ⅠstudyPhase Ⅱa studyPhase Ⅱb studyPhase Ⅲ study two comparative trials in Japan

haloperidolmosapramine → atypicals

(risperidone)Long-term study

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