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Jun 1, 2000 · The uncertainty that remains after the best possible analysis has been undertaken is what we call residual uncertainty—for example, the outcome of an ongoing regulatory debate or the performance attributes of a technology still in development. But quite a bit can often be known despite this.
helps to determine an allowance to account for residual uncertainty. For this guide, the residual uncertainty allowance is defined as: An allowance that seeks to assure the present day...
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The uncertainty that remains after the best possible analysis has been done is what we call residual uncertainty —for example, the out-come of an ongoing regulatory debate or the performance attributes of a technology still in development. But often, quite a bit can be known about even those residual uncertain-ties.
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Cost of residual non hedgeable risk The cost of residual non hedgeable risk is designed to capture the allowance for risk that is not explicitly made in the PVFP or TVFOG and ensures that the MCEV is focused on the mean value of the shareholder interest in the distributable earnings. Guidance 9.1 to 9.3 discusses
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- What Is Residual Uncertainty ?
- What Does The Guidance Say and How Does It Apply to Biosimilar Program ?
- Why Is It Important to Understand This Phrase ?
According to Business Dictionary residual uncertainty is Exposure to loss remaining after other known riskshave been countered, factored in, or eliminated. How does this phrase play into Biosimilars ? This phrase is often peppered throughout the BPCIA and biosimilar guidances published by the agency. Specifically its mentioned quite prominent in th...
“FDA recommends that sponsors use a stepwise approach to developing the data and information needed to support a demonstration of biosimilarity. At each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product and identify next steps to try to address that uncertainty. Where...
This is a powerful tool that can be utilized when minor or minute differences are found in your data relative to the comparative studies conducted in the Biosimilar program. The completeness of the package will be subject to this interpretation and gives the agency both intellectual and scientific powers that may be difficult to defend. Therefore i...
Sep 26, 2021 · The main advantage of using exposure models over direct measurement is cost and time – in general at the price of a higher degree of uncertainty. A prerequisite for exposure analysis is that the state of knowledge about all the different influence factors is sufficient and that existing knowledge might be translated into an exposure model.
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What is residual uncertainty?
What is residual uncertainty in biosimilars?
Does residual uncertainty affect strategic decisions?
How do managers evaluate residual uncertainties?
The four levels of residual uncertainty. One of Courtney’s contributions to the literature of strategy was a four-part framework to help managers determine the level of uncertainty surrounding strategic decisions.
