performance shown by the bottom subplots was assessed on a test dataset obtained by selecting data points exceeding a certain fuel injection quantity (exceeding 75th percentile of all data), while the training data comprised all data points below that threshold.
Both the EMA and the FDA allow for the extrapolation
of biosimilars on a case-by-case basis.
A basic parallelism, but one that does not set up extrapolation
to the incalculable, occurs in Rima XXXVI (LIV):
In equations 1-6 were used for the determination of intrinsic viscosity by graphic extrapolation
as well as by single point method of dilute solution.
The methods proposed in [2, 13] implicitly used the zeroth-order HL consistency condition; that is, the DC term is the same for all projections, as a constraint for data extrapolation
. The first-order condition, which corresponds to the first moment of the projections and describes the so-called "center of mass," was also used to guide the extrapolation
In Section 2, a brief review of popular vector extrapolation
methods is provided.
Most of the physicians surveyed don't clearly understand the concept of extrapolation
as applied to biosimilars, with just 12% of respondents stating that they trust extrapolation
of the studied biosimilar indication(s) as the basis to obtain approval of other licensed indications of the originator product, according to the study.
Despite this theoretical disagreement, I have no quarrel with most of Schmeink's observations on the social influence of new biotechnologies, and on how science fictional extrapolation
allows us to comprehend this.
Another issue to consider is that of retrograde extrapolation
. While explaining this process, Kurtz stated that when a person first consumes alcohol, his or her blood alcohol level will rise as the alcohol is being absorbed into the system.
The more points of similarity (jurisdiction, supplies and labor costs, identity of tests being compared) between a published study and the location of interest, the more applicable this extrapolation
The overall thrust of the extrapolation
issue was that if biosimilarity to Remicade was proven by a range of preclinical and clinical testing, and if safety and efficacy similar to Remicade was shown in trials that enrolled only patients with rheumatoid arthritis or ankylosing spondylitis, then the safety and efficacy previously proven for Remicade for the other indications could be reasonably extrapolated to apply to CT-P13 also, even though CT-P13 was never tested on patients with those conditions.
Additionally, poor low-frequency information leading to DC extrapolation
errors also degrades model accuracy and leads to poor agreement with 3-D EM simulators.
In order to improve the efficiency of the CMG, some new extrapolation
formulas and extrapolation
cascadic multigrid (EXCMG) methods are proposed by Chen et al.
Doesn't that change the basic extrapolation
on which it was founded?"