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On
the Horizon >> Safety & Efficacy
Probiotics
are Generally Regarded As Safe (GRAS) by regulatory
authorities and live bacteria have been available to consumers
for many years in dairy products.
The
recognised safety and efficacy of Bif 35624 in
treating IBS patients is a significant scientific milestone
for the company as it clearly identifies the potential
of this class of therapeutic in treating specific chronic
diseases.
By
demonstrating early evidence of clinical efficacy,
the company can provide pharmaceutical partner companies
with a significant advantage over conventional drug development.
AH can progress its probiotic based products to early
Phase II proof of principle clinical trials in
approximately 1/3 of the time of conventional pharmaceutical
products.
The
inherent safety profile of this class of therapeutic also
reduces the risk of safety issues arising at late stage
clinical trials or post marketing approval.
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