Примери за използване на Applicant stated на Английски и техните преводи на Български
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Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Safety data obtained from clinical study and non-clinical toxicity study The Applicant stated that the dosing regimen of teicoplanin is predictable, therefore dose-dependent toxicity is not of concern under standard clinical use.
The applicant stated to the Ombudsman that the information provided by the Commission was still incomplete.
In response to the inquiry made in accordance with Rule 33§ 3(d)of the Rules of Court, the applicant stated that he wished to take part in the proceedings pending before the Court and designated the lawyer who would represent him(Rule 30).
The applicant stated that the shaving of his head had been a barbaric act lacking any legal basis.
In its letter notifying the Agency of the withdrawal of application, the applicant stated that it was withdrawing the application since it would require a further time extension to provide the responses to the CHMP's questions.
The Applicant stated that a number of key studies in the paediatric population have indicated that intranasal corticosteroids are effective and well-tolerated and discussed single studies from the literature.
In order to justify the omission of bioavailability studies in the paediatric population, the Applicant stated that the results from a therapeutic equivalence study did not provide any indication of differences in systemic exposure or adverse events resulting from the active substance.
The applicant stated that this phenomenon had been documented by human rights monitoring organisations and had been acknowledged by the Bulgarian government.
Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
The applicant stated that she was continuing to suffer psychological trauma years after she had been raped.
(d) of the Rules of Court, the applicant stated that she wished to take part in the proceedings and designated the lawyers who would represent her(Rule 30).
The applicant stated that he had admitted the offence, he had a seven-month old child and wanted to preserve his family.
In her submissions to the investigator, the applicant stated that she had later come to suspect that the three men had planned to have sex with her and had invented the pretext of swimming to drive to a deserted area.
The Applicant stated that the reference product in all bioequivalence studies conducted was Pantecta, marketed in Spain.
The applicant stated that Mr Tsonchev was the person with whom she had been living for twelve years and who was the father of her three children.
The applicant stated that Bulgarian legislation contained no provisions guaranteeing access to a doctor for persons deprived of their liberty.
The Applicant stated that the antimicrobial potency of the drug is a sum of the component parts and that In vitro antibacterial potency is established by MIC testing.
The Applicant stated that growth is divided into 3 distinct age-related phases and that conclusions from studies in one age group cannot be generalised to other age groups.
The applicant stated that her attempts to obtain a revision of the prohibition on her leaving Bulgaria were to no avail as the authorities acted arbitrarily and refused to examine her arguments.
The applicant stated that the only remedy which he had at his disposal was the possibility of filing appeals against order no. 99 to the prison administration and the Deputy Minister of Justice.
The applicant stated that under Bulgarian law it was not possible to obtain compensation for detention which violated the Convention but was effected in accordance with the requirements of the CCP.
The applicant stated that under Bulgarian law it was not possible to obtain compensation for detention which violated the Convention but was nevertheless ordered in accordance with the formal requirements of the Code of Criminal Procedure.
The Applicant stated that appropriate loading doses of teicoplanin must be considered mandatory for all patients regardless of their renal function in order to achieve therapeutically relevant concentrations early in the treatment period.
The applicant stated in its request for a review that it had not participated in the original investigation since it did not know the final destination of its goods, which it sold during the investigation period solely to one Chinese trading company.
The Applicant stated that generic applicants do not have access to the specifications of the originator products and that it therefore attempted to develop an API containing subcomponents at levels similar to that seen in Targocid.
The Applicant stated that the only difference with the originator product is an additional 0.01% of ascorbic acid, a well-characterised chemical substance and a well-established excipient in locally applied products, with no reported adverse effects.
The Applicant stated that no protocol was established before the in vitro comparison but that in house documents with pre-specified criteria were used and that test product batches were subjected to release and stability testing according to protocols from the quality control department.
The Applicant stated that the only relevant measure of efficacy for this kind of product is the level of protective anti-HBs achieved in the plasma, since after the introduction of vaccination it is no longer feasible to assess the efficacy of the product on the basis of the incidence of new infections.
The applicant stated that under the national law and practice at the relevant time the scope of judicial review of detention was very limited and that as a result none of the decisions in his case had included a proper analysis of all the factors determining the detention's lawfulness.