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is a privately-held biotechnology company that develops and markets unique cellular imaging systems for the life sciences market.
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For 50 years, Waters has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance.
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is a privately-held biotechnology company that develops and markets unique cellular imaging systems for the life sciences market.
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For 50 years, Waters has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance.
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Blog
Chairman, GDS International
Sales and the 'Talent Magnet'
A lot is written about being a ‘Talent Magnet’, either as a company, or as President. It’s all good practice – listen, mentor, reward, provide clear goals and career maps. Good practice for the employer, but what about the employee?26 May 2011
White Papers
Focus Area: Clinical Trials
Don’t be fazed by phases
Mike Butler explains how Xceleron is helping its clients to answer critical clinical development questions.
What is the importance of the FDA guidance document ‘Suicidality: Prospective Assessment of Occurrence in Clinical Trials’ and how can I comply?
What is the importance of assessing suicidal ideations and behaviors in drug trials? How can we best accomplish this assessment during drug development? Is this an area of concern in therapeutic areas previously considered to have minimal psychiatric side effects, such as asthma, acne and insomnia? These are the questions that this FDA Guidance seeks to clarify. In addition, there is also a lack of conceptual clarity and well-defined suicidal behavior terminology that means investigator variability can occur when assessing suicidal tendencies in clinical trial participants. This can then lead to suicidal behaviour and ideation not being consistently or accurately identified.
Meeting global compliance challenges
Improving cross-border compliance enables pharmaceutical companies to streamline global operations, lower costs and speed products to market – all while serving an increasingly segmented market
Translational ADME-Tox models
What are the strategies for reducing drug attrition rates in the clinic through the application of transgenic ADME-Tox rodent models? By Nico Scheer, PhD
Using ePRO solutions to ensure compliance with FDA guidelines on the prospective assessment of suicidal ideation and behavior
Preventing, monitoring and understanding treatment-related suicidal ideation and behavior relies upon proactive assessment and identification. However, there has been a lack of clarity and standardized approaches in clinical trials when assessing suicidal tendencies. As a result, drug safety efforts have often been undermined. To ensure patients are proactively identified and treated for suicidal symptoms, the U.S Food and Drug Administration (FDA) recently released a guidance document, entitled: ‘Guidance for Industry: Suicidality Prospective Assessment of Occurrence in Clinical Trials’.
Source: www.ngpharma.com© 2012 GDS Publishing Ltd. All rights reserved.