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They applied their kinetic four-pool model to 14C-labeled residues measured by aerobic soil incubation studies reported in dossiers submitted for authorization of eight PPPs and determined parameters for first-order kinetic rate constants by fitting time series from 40 studies.
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization.
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In addition, researchers must release a full clinical study report which contains detailed information about the trial design and analysis, including patient-level data sets if the medicine is submitted for marketing authorization, irrespective of that application's success.
In the U.S., health insurers are increasingly requiring that services provided to patients be submitted for prior authorization (PA) [ 1].
With regard to benefit, it is unlikely that an agent will be submitted for marketing authorization if it does not meet recognized approvable efficacy criteria.
The policy stipulates that the EMA database, including clinical trial reports submitted for marketing authorization of medicines as of January 2015, will be made available to the public in line with the new EU Clinical Trial Regulation No 536/2014.
Of particular note is the European Union's (EU Chemicals Associationn's ECHA CHEM database [10], which is comprised of information submitted for chemical substances registered under the registration, evaluation, authorization and restriction of chemicals (REACH) regulation [11] as well as information in the ECHA C&L (Classification and Labeling) Inventory [12].
The study was submitted for validation in the Ethic Committee Hospital 12 de Octubre as stated in the Royal Decree 223/2004 and Article 58 of Law 29/2006 for Post Authorization Retrospective studies.
Chemical Engineering Science, submitted for publication).
Res., submitted for publication].
Top., submitted for publication].
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