"The present Guidelines call for an observation period of 14 days, during
which period the regression of toxic reactions must be followed by
observation of any changes in clinical signs and body weight".
I hope this answers your question.
Please be aware that all Japanese Pharmaceutical and Medical Device
Regulations are available in English through Interpharm Press, 1358
Busch
Parkway, Buffalo Grove IL 60089, USA.
Ph: +1+847 459 8480 Fax: +1+847 459 6644
The above manual is available at US$ 312 (it includes all non-clinical
(pre-clinical) test guidelines.
Best Regards,
Mike Anisfeld anisfeld@ix.netcom.com
At 02:58 PM 9/25/1996 -0400, you wrote:
>Looking to see if Japan accepts 14 day tox. data for single dose product
>as opposed to the common 28 days for multi-dose products.
>
>Thanks for any information.
>
>
>Douglas B. Hecker dhecker@qni.com
>
>
>
>
>
>
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Michael Anisfeld Specialists in mock-FDA and
GMP audits,
Interpharm Consulting Quality Assurance System Design,
Training
1358 Busch Parkway
Buffalo Grove IL 60089, USA Ph: USA +1+847 459 8480
Fx: +1+847 459 6644
e-mail: anisfeld@ix.netcom.com