Примери за използване на Subcomponents на Английски и техните преводи на Български
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Colloquial
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Purchase of subcomponents.
The subcomponents are separated by HPLC according to their polarity.
One step manufacturing includes sourcing of subcomponents and hardware overseas partners.
Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Unicode provides a mechanism for composing Hangul syllables with their individual subcomponents, known as Hangul Jamo.
It consists various subcomponents such as personnel management, organisation management, Time management and payroll.
In this study, FABLYN significantly increased spine andhip(total hip and all subcomponents of the hip) BMD by 2 to 4%.
Limits for all individual subcomponents were established based on batch data at release and during stability testing.
The overall system and software will be programmed by Tesla, butwe will certainly use sensors and subcomponents from many companies.”.
Both products include the same subcomponents and despite differences in the subcomponent ratios, both comply with the European Pharmacopoeia(Ph. Eur.).
Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents and has shown to be bio-inequivalent to the originator.
All subcomponents are well characterised and readily identifiable and there is no doubt that each individual subcomponent in Teicoplanin Hospira has the same characteristics as in Targocid.
It was considered that Teicoplanin Hospira and Targocid are comparable in terms of overall active drug content, butdiffer in the composition of the TA-2 subcomponents, resulting in major objections.
It is a complex antibiotic,consisting of six closely related glycopeptide subcomponents(A2-1, A2-2, A2-3, A2-4 and A2-5 forming A2 group, and A3) as defined in the current European Pharmacopoeia Ph.
The Applicant stated that generic applicants do not have access to the specifications of the originator products andthat it therefore attempted to develop an API containing subcomponents at levels similar to that seen in Targocid.
The Applicant considered the AUC/MIC ratio individually for all 5 subcomponents, for the free drug, as teicoplanin is extensively protein bound, and the biological activity of the preparation mainly results from the free drug component.
Teicoplanin Hospira has a different sub-component mix to the originator;however the Applicant considers that it is not reasonable to use total teicoplanin MICs to assess the impact of differing proportions of subcomponents.
The CHMP noted that for Teicoplanin Hospira to be considered as a generic product,the difference in the amounts of glycopeptides subcomponents must be acceptable and that this difference must not lead to a difference in safety and/or efficacy.
The Applicant discussed the variation in subcomponent levels and stated that bioequivalence or essential similarity for Teicoplanin is best assessed by comparing the sum of free AUC/MIC for the subcomponents.
The pharmacokinetics of teicoplanin has been determined for both the total complex and for the individual components andanalyses of the subcomponents confirmed that the pharmacokinetics of the individual TA2 subcomponents are the same for Teicoplanin Hospira and Targocid.
Finally, the in vitro MIC studies performed by the Applicant are not sensitive enough to detect any differences between the two products since in vitro anti-bacterial activity is independent of lipophilicity,tissue distribution and clearance of the subcomponents.
Regarding the available literature concluding that Teicoplanin should be treated as a whole regardless of the relative levels of subcomponents, the CHMP is of the opinion that this would have been considered during the development of the Ph. Eur.
The Applicant concluded that taking into account the teicoplanin subcomponents and their relative amounts, lipophilicity and MIC's, numerous experts believe that in a clinical setting, teicoplanin should be treated as a whole, regardless of the relative levels of subcomponents, due to the differences in PK characteristics being small.
It reminded me not only of Pert's assertion that she no longer knows where the brain leaves off and the body begins, butmade me wonder if perhaps all of the body's subcomponents- glands, bones, organs, and cells- possess their own intelligence?
The free drug AUC/MIC for the sum of TA2 subcomponents for Teicoplanin Hospira was within 2% of the Targocid value and the totality of the pre-clinical MIC studies combined with the mouse thigh study and the identical bactericidal serum titres give re-assurance that the microbiological activity of the two products is the same and that pharmacodynamically, the two products can be considered equivalent.
Protein binding was assessed, showing that the unbound fraction for each sub-component was essentially similar for Targocid and Teicoplanin Hospira andconfirming that the individual protein binding values for the subcomponents did not vary with the different component composition.
The half- lives of the TA2 components correlates to their lipophilicity, andbecause Teicoplanin Hospira has a lower proportional content of subcomponents with a longer half-life and a higher proportion with a shorter half-life, the overall elimination of total teicoplanin is faster, and the resulting AUC is lower.
The CHMP was also of the opinion that the study conducted by the Applicant did not demonstrate bioequivalence between Teicoplanin Hospira and Targocid and that the MIC studies are not sensitive enough to detect differences between the two products in the case of teicoplanin, since in vitro anti-bacterial activity is independent of lipophilicity,tissue distribution and clearance of the subcomponents, i.e. differences in systemic exposure.
In conclusion, the CHMP noted that although complying with the European Pharmacopoeia monograph,the quality of Teicoplanin Hospira is different from the innovator subcomponents as Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents.
The results show that free drug for each teicoplanin subcomponent was similar.