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Regulatory Approval

News Regulatory Approval

  • Do some prescriptive sleeping pills posses a danger?

    In a trial of one of the main class of prescription sleeping pills, half the participants slept through a fire alarm as loud as someone vacuuming next to their bed. But a newer alternative preserves the ability to wake in response to danger signals, according to a new research. The study showed that more

  • Multinational companies continue to produce unregulated antibiotics in India

    Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University. The research found that multinational companies continued to manufacture many unapproved formulations, despite pledging to tackle rising an more

  • Drug Approval: New Country Comparison Shows Great Savings Potential

    The regulatory requirements for the approval of new drugs vary greatly internationally in regards to the resources allocated to the authorities, the evaluation periods for approval and the fees for the pharmaceutical companies. This reports a study of the European Center of Pharmaceutical Medicine a more

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White papers Regulatory Approval

  • Characterizing Biotherapeutics with HPLC

    As demonstrated here, there are a broad range of HPLC applications used in development, production, validation and release of protein therapeutics for human use. Some of the applications mentioned above are mandatory when submitting a new biopharmace more

  • Clinical Biomarkers: Novel Tools for Pharmacodynamic Applications

    Biomarkers are currently changing the way we diagnose and treat diseases. Today pharmacodynamic biomarkers are widely used in the industry elaborating optimal dosing of new drugs and predictive biomarkers have an enormous potential for companion diag more

Publications Regulatory Approval

  • Biomarkers as drug development tools: discovery, validation, qualification and use

    The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts more

  • Clinical use of lentiviral vectors

    Viral vectors provide an efficient means for modification of eukaryotic cells, and their use is now commonplace in academic laboratories and industry for both research and clinical gene therapy applications. Lentiviral vectors, derived from the human immunodeficiency virus, have been extensively inv more

  • Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection

    Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of op more

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