Übersetzung für "Acceptance range" in Deutsch

In case of an especially narrow therapeutic range the acceptance range may need to be tightened.

The aim of a bloequlvalence study is to demonstrate equivalence within the acceptance range regarded as clinically relevant.

A larger acceptance range may be acceptable if Inevitable and clinically acceptable.

The Applicant considered that the PK results for whole teicoplanin demonstrated that Cmax and Tmax of Teicoplanin Hospira and Targocid were essentially similar, and the 90% CI for Cmax was within the acceptance range for bioequivalence.

Question 3 - The Applicant´s justification to widen the acceptance range taken from the draft guideline is not acceptable.

The calculated 90% CI for AUC0-t, AUCinf and Cmax for the metabolite descarboethoxyloratadine were within the 0.80- 1.25 acceptance range, but bioequivalence for loratadine tablets should also be based on parent compound data and because the 90% CI for Cmax and AUC of the parent compound were outside the standard 0.80 - 1.25 acceptance criterion, the objecting concerned member states considered that bioequivalence between Loratadine Sandoz 10 and the reference product could not be established.

The Marketing Authorisation Holder should conduct a new fasting and fed bioequivalence study showing the bioequivalence of Ciclosporin IDL under a tightened acceptance range (90-111%) for the 90% CI.

The CHMP stated that the draft guideline proposed a more conservative approach to the applied acceptance range mainly due to lack of experience in this filed and the fact that pooling may mask the differences in the evaluated products, as is the case for the current product.

The CHMP agreed with the EWP PK expert group position that if ciclosporin is considered a narrow therapeutic index drug, a narrowed (90-111%) acceptance range should be applied for AUC.

In the MAH view even if Ciclosporin was to be considered a NTI drug, the normal 80-125% acceptance range should be used.

A post hoc justification for widening the acceptance range as was done for study SZ190/08 can therefore not be accepted.

It was concluded that any arguments for the widening of the acceptance range must be discussed prospectively, and reflected in the protocol.

The data showed that for loratadine, the 90% confidence interval for Cmax is outside the predefined acceptance range of 80-125% (although the 90% confidence intervals for AUC0-t, AUC0-? were respected).

When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range.

Bioequivalence with the reference product (Mifegyne) was demonstrated for AUC while the Cmax was slightly above the conventional acceptance range of 80-125% (the Cmax ratio (90% CI) was 114.4 (103.33-126.66)).

Concurrent NC and PC should be used in each run to demonstrate that viability (with the NC), barrier function and resulting tissue sensitivity (with the PC) of the tissues are within a defined historical acceptance range.

Concurrent NC and positive controls (PC) should be used for each study to demonstrate that viability (NC), barrier function and resulting tissue sensitivity (PC) of the tissues are within a defined historical acceptance range.

The sequence number, however, must thereby lie within an acceptance range, otherwise, the cell is recognized as invalid.

This technology has found widespread acceptance across a range of industries, such as the automotive industry, the printing sector (including smart packaging, advertising and media), as well as the consumer electronics industry.

Since their introduction over 30 years ago, conductive rubber switches and keypads have gained enormous popularity and wide-range acceptance because of their reliability, long operational life and excellent tactile feel.