Selection of Investigational Medicinal Products and Dosages Sample Clauses

Selection of Investigational Medicinal Products and Dosages. Published data provide information from over 400 patients with NDO treated with doses ranging from 500 to 1000 U Dysport®. Across a number of clinical studies, all doses were reported as efficacious. However, the 500 U dose has been reported to be less effective compared to higher doses [15, 11], while the 1000 U dose was associated with a higher incidence of treatment-related AEs [10, 11, 13]. Results from the Ipsen placebo controlled phase IIa study, which used the exploratory dose of 750 U, demonstrated a favourable benefit/risk balance [17] (Section 1.3.2). It is expected that a difference of 200 U will allow dose discrimination based on the balance between efficacy and safety; therefore, for phase III, doses of 600 U and 800 U have been selected for further evaluation. The dose of 600 U is anticipated to have greater efficacy than that reported with 500 U; while the 800 U dose is expected to demonstrate a higher degree of efficacy, without jeopardizing the safety profile and thus providing a second clinically relevant dose. Thus, it is anticipated that with a 200 U difference, the two doses are sufficiently differentiated to enable an evaluation of the benefit/risk of both doses without significantly increasing the safety risk.
Sample 1
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Related to Selection of Investigational Medicinal Products and Dosages

  • Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.

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  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

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  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

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