Ophthalmic and Otic Drug Administration: Novel Approaches and Challenges

Preclinical biomarker qualification

Experimental Biology and Medicine ◽

10.1177/1535370217743949 ◽

2017 ◽

Vol 243 (3) ◽

pp. 222-227 ◽

Cited By ~ 6

Author(s):

John-Michael Sauer ◽

Amy C Porter ◽

Keyword(s):

Drug Development ◽

Drug Administration ◽

Medical Devices ◽

Food And Drug Administration ◽

European Medicines Agency ◽

Clinical Biomarkers ◽

New Information ◽

History Of ◽

Novel Biomarkers ◽

Novel Approaches

Biomarkers are ubiquitously used within drug development programs in both nonclinical species and in humans to assess safety and efficacy of novel compounds. To routinely apply such novel biomarkers with certainty, a well-defined data package is necessary for review and endorsement by regulatory agencies including the US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency. This type of endorsement is known as regulatory qualification. Novel approaches are being applied to speed the process, lower the resource intensity, and increase the accessibility of biomarker qualification data and it is likely that consortia will continue to play a fundamental role in the qualification process by bringing together like-minded stakeholders focused on specific tools to accelerate drug development. This article will focus on learnings from the previous three nonclinical biomarker qualification projects, as well as discuss the progression of preclinical biomarker projects into the clinical qualification space and the current strategy for the use of nonclinical biomarker data in the translational qualification of clinical biomarkers; much like nonclinical information is used in the approval of drug development candidates. Impact statement This minireview provides an overview of the history of preclinical biomarker qualification by summarizing the three examples of this type of qualification with US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency. In addition, an overview of the biomarker qualification process is included to educate key stakeholders with links to relevant white papers that provide information on current evidentiary considerations. The manuscript also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process.

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Novel Approaches to Low-Voltage Scanning Electron Microscopy

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100180586 ◽

1990 ◽

Vol 48 (1) ◽

pp. 366-367

Author(s):

Arthur V. Jones

Keyword(s):

Electron Microscopy ◽

Scanning Electron Microscopy ◽

Low Voltage ◽

Electron Optics ◽

Current Interest ◽

New Concepts ◽

Opportune Time ◽

Novel Approaches ◽

Voltage Scanning ◽

Scanning Electron

In comparison with the developers of other forms of instrumentation, scanning electron microscope manufacturers are among the most conservative of people. New concepts usually must wait many years before being exploited commercially. The field emission gun, developed by Albert Crewe and his coworkers in 1968 is only now becoming widely available in commercial instruments, while the innovative lens designs of Mulvey are still waiting to be commercially exploited. The associated electronics is still in general based on operating procedures which have changed little since the original microscopes of Oatley and his co-workers.The current interest in low-voltage scanning electron microscopy will, if sub-nanometer resolution is to be obtained in a useable instrument, lead to fundamental changes in the design of the electron optics. Perhaps this is an opportune time to consider other fundamental changes in scanning electron microscopy instrumentation.

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