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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 an

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

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  1. 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)

  2. Use of placebo Antidepressants (1)

  3. 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

  4. Antidepressants (3) Phase Ⅰstudy Phase Ⅱa study Phase Ⅱb study Phase Ⅲ study two comparative trials TCA trazodon → SSRI SNRI Long-term study

  5. Use of placebo Antipsychotics (1) Schizophrenia-Progressive and irreversible the earlier, the better

  6. Antipsychotics (2) 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

  7. Antipsychotics (3) Bridging study (2) protocol subject group acute/acute exacerbation USA chronic Japan method for drug therapy mono therapy USA combination therapy Japan

  8. 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

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