Comments for Drug Development Consultant and Regulatory Consultant http://www.damienbove.com Damien Bove Shares The Expertise Mon, 08 Mar 2010 07:51:02 +0000 http://wordpress.org/?v=2.9.2 hourly 1 Comment on ICH M3 (R2) Non-clinical Safety Studies Guidance updated by EMEA by admin http://www.damienbove.com/2009/07/28/ich-m3-r2-non-clinical-safety-studies-guidance-updated-by-emea/comment-page-1/#comment-7410 admin Mon, 08 Mar 2010 07:51:02 +0000 http://www.damienbove.com/?p=503#comment-7410 Hello, In most cases I would be confident that you can make an argument quickly and easily that a local tolerance test is not going to be required in this situation, however without knowing the details of the particular product I never say never, but it would be difficult to see a case why you would need it. Regards Damien Hello,

In most cases I would be confident that you can make an argument quickly and easily that a local tolerance test is not going to be required in this situation, however without knowing the details of the particular product I never say never, but it would be difficult to see a case why you would need it.
Regards

Damien

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]]> Comment on ICH M3 (R2) Non-clinical Safety Studies Guidance updated by EMEA by Local Tolerance studies needed for oral formulations and Intrmuscular injectables http://www.damienbove.com/2009/07/28/ich-m3-r2-non-clinical-safety-studies-guidance-updated-by-emea/comment-page-1/#comment-7308 Local Tolerance studies needed for oral formulations and Intrmuscular injectables Fri, 05 Mar 2010 05:36:46 +0000 http://www.damienbove.com/?p=503#comment-7308 Dear Sir/ Mam Plz let me know whether local tolerance studies is needed for oral formulations (Generic) also. Dear Sir/ Mam

Plz let me know whether local tolerance studies is needed for oral formulations (Generic) also.

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