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What is residual uncertainty?
Does residual uncertainty affect strategic decisions?
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What is residual uncertainty in biosimilars?
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.
- Clear Enough/Predictable Future. This would apply to situations where sufficiently precise predictions can be made about key variables affecting a company’s markets and businesses (e.g.
- Alternative Futures. Sometimes firms are faced with discrete scenarios, e.g. regulatory changes, significant actions of competitors, etc. It’s hard to predict which outcome will actually happen, although one can assign probabilities to various alternatives.
- Range of Futures. Unlike level two (where the outcome is either-or), in level three, a small number of variables define a broad range out outcomes, but the actual result may lie anywhere in between.
- True Uncertainity/Ambiguity. This type of uncertainty is actually quite rare. It may happen in cases of entirely new technologies where technology adoption, platform prevalence, competitive landscape and revenue models are all up in the air.
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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- 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...
A residual (or fitting deviation), on the other hand, is an observable estimate of the unobservable statistical error. Consider the previous example with men's heights and suppose we have a random sample of n people.
The uncertainty that remains after the best possible analysis using the best available information is residual uncertainty. It falls into one of four broad levels as shown below. (McKinsey, 2000)
Feb 24, 2021 · Accounting for residual uncertainty: an update to the fluvial freeboard guide. This new research will help flood risk managers identify and manage uncertainty in their flood risk assessment and...
