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Application of a Degree-Hour Approach for the Management of Over-Temperature

(OT) Excursions for Investigational Medicinal Products (IMPs) and Non-
Investigational Medicinal Products (NIMPs)

, David LeBlond
,David G. Stroz,
Shelly J. Asmussen, Ph.D.
M.S. Apr 26, 2016 7:00
By ,Dennis A. Stephens, Ph.D.
am PDT

This publication describes how to convert degree-hour measures of over-temperature (OT) allowances to hours within a
defined temperature range. Additionally, it will be shown how to derive the appropriate Hour Conversion Ratio (HCR) to
convert a number of hours in a higher temperature Tier to an equivalent number in a lower Tier for accounting purposes.
Finally, the division of Tiers into smaller Mini-Tiers is described. Mini-Tiers are used to provide a finer granularity which allows
more economical "expenditure" of the allocated OT allowances.

Source URL: http://www.ivtnetwork.com/article/application-degree-hour-approach-management-over-

temperature-ot-excursions-investigational-m