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58 Newest Publications about the topic regulatory approval


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

14-May-2018 | Virginia B. Kraus, Nature Clinical Practice Rheumatology, 2018

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 ...


Clinical use of lentiviral vectors

22-Mar-2018 | Michael C. Milone; Una O’Doherty, Leukemia, 2018

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 ...


Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection

01-May-2017 | Willemieke S. Tummers; Jason M. Warram; Kiranya E. Tipirneni; John Fengler; Paula Jacobs; Lalitha Shankar; Lori Hend ..., Cancer Research, 2017

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 ...


[In Depth] Antisense rescues babies from killer disease

16-Dec-2016 | Meredith Wadman, Science , 2016

Spinal muscular atrophy, the leading inherited killer of children, has forced generations of parents to watch their kids become progressively weaker and, in severe cases, die by about their second birthdays.The recessively inherited disease inexorably destroys the motor neurons of the spinal ...


Predictive glycoengineering of biosimilars using a Markov chain glycosylation model

17-Nov-2016 | Philipp N. Spahn, Anders H. Hansen, Stefan Kol, Bjørn G. Voldborg, Nathan E. Lewis, Biotechnology Journal, 2016

Abstract Biosimilar drugs must closely resemble the pharmacological attributes of innovator products to ensure safetyand efficacy to obtain regulatory approval. Glycosylation is one critical quality attribute that must be matched, but it is inherently difficult to control due to the complexity ...


Dynamic population PK/PD modeling and simulation supports similar efficacy in HbA1c response with once or twice‐daily dosing of canagliflozin

08-Nov-2016 | Willem Winter, Adrian Dunne, Xavier Woot deTrixhe, Damayanthi Devineni, Chyi‐Hung Hsu, Jose Pinheiro, David Polidori, British Journal of Clinical Pharmacology, 2016

Aim Canagliflozin is an SGLT2 inhibitor approved for the treatment of type‐2 diabetes. A dynamic population pharmacokinetic‐pharmacodynamic (PK/PD) model relating 24‐hour canagliflozin exposure profiles to effects on HbA1c was developed to compare the efficacy of once‐daily and twice‐daily ...


Approved and Experimental Small‐Molecule Oncology Kinase Inhibitor Drugs: A Mid‐2016 Overview

24-Oct-2016 | Peter M. Fischer, Medicinal Research Reviews, 2016

Abstract Kinase inhibitor research is a comparatively recent branch of medicinal chemistry and pharmacology and the first small‐molecule kinase inhibitor, imatinib, was approved for clinical use only 15 years ago. Since then, 33 more kinase inhibitor drugs have received regulatory approval for ...


Plant based oral vaccines against zoonotic and non‐zoonotic diseases

21-Jul-2016 | Naila Shahaid, Henry Daniell; Naila Shahid, Henry Daniell, Plant Biotechnology Journal, 2016

Abstract The shared diseases between animals and humans are known as zoonotic diseases, and spread infectious diseases among humans. Zoonotic diseases are not only a major burden to livestock industry but also threatens humans accounting for >60% cases of human illness. About 75% of emerging ...


Ion channels find a pathway for therapeutic success [Pharmacology]

17-May-2016 | Maria L. Garcia; Gregory J. Kaczorowski, Proceedings of the National Academy of Sciences current issue, 2016

Drug discovery and development are complex processes that require long-term commitments to bring such efforts to fruition. Traditionally, there is low probability of success in being able to take new pharmacological agents all of the way through regulatory approval for use in man. There are ...


Statistical analysis of data from limiting dilution cloning to assess monoclonality in generating manufacturing cell lines

26-Apr-2016 | Jorge Quiroz, Yung‐shyeng Tsao, Biotechnology Progress, 2016

Abstract Assurance of monoclonality of recombinant cell lines is a critical issue to gain regulatory approval in biological license application (BLA). Some of the requirements of regulatory agencies are the use of proper documentations and appropriate statistical analysis to demonstrate ...


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