80 likes | 190 Views
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).
E N D
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) 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) Phase Ⅰstudy Phase Ⅱa study Phase Ⅱb study Phase Ⅲ study two comparative trials TCA trazodon → SSRI SNRI Long-term study
Use of placebo Antipsychotics (1) Schizophrenia-Progressive and irreversible the earlier, the better
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
Antipsychotics (3) Bridging study (2) protocol subject group acute/acute exacerbation USA chronic Japan method for drug therapy mono therapy USA combination therapy Japan
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