Exact(2)
If comparability of the biosimilar product and reference product is verified through quality evaluation, other toxicological studies are not generally required, unless triggered by results of the repeat-dose toxicity study and/or by other known toxicological properties of the reference product.
If comparability between current utilities and EQ-5D derived utilities is important for a particular cost-utility model, it is recommended that modelers use the utility values derived in the 10-year TTO assessment, which is consistent with the methods originally used to value EQ-5D health states [ 78].
Similar(58)
It would be a good thing if the initiative were taken to assemble comparable data and see if more comparability can be brought into quantities which are currently often not comparable.
These results have also to be discussed in the context of the international existing literature, even if the comparability of country-specific results is limited due to differences in the treatment and reimbursement structure of different health care systems.
Studies were also rated as LoE "poor, high risk of bias" if the comparability of groups with respect to study procedures was deemed compromised (Item 1.6).
Importantly, if this comparability exercise shows that the biosimilar can be shown to be highly similar for both pharmacokinetic and pharmacodynamic data, without raising any additional safety or efficacy questions that require clinical testing, the EMA does not require clinical efficacy studies 19.
But including control variables into a model will only improve the comparability if the functional relation between control and dependent variable is modeled correctly.
Orientation D is locally transitive if G[〈v,w〉] is transitive, for each edge (v,w) of D. Graph G is local comparability if it admits a locally transitive orientation.
At the other extreme, utilities are measured on a ratio scale with full interpersonal comparability if those profiles yield the same social ordering that can be obtained from each other by rescaling, or multiplying all utility functions by the same positive real number.
Even under "sustainable" forest management, e.g., when harvest does not exceed forest growth (so the forest carbon stock does not decline), omitting a policy-driven decrease of the sink from the accounts cannot be justified if credibility and comparability with other sectors is to be maintained.
The validity of these conclusions is further jeopardized if the pretest comparability of participants is not maintained.
Write better and faster with AI suggestions while staying true to your unique style.
Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com