White Papers
Our white papers are written by technical experts from many different fields, exploring and commentating on a range of complex subjects.
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A Method for the Qualitative and Quantitative Determination of the Amino Acid Composition of Pharmaceutical Products
This paper outlines the development of a liquid chromatography method for simultaneous determination of approximately 20 amino acids in simple and complex mixtures that complies with the system suitability requirements of the Ph. Eur. general chapter (2.2.56). |
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Qualification of an Assay with Applications for Investigating Functional Comparability of an Originator and Biosimilar
This paper reviews the qualification of cell-based assays for functional comparability analysis that provide an attractive alternative to more expensive and time-consuming assays. |
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ISO 14001:2015 – What You Need to Know
We give a brief introduction to ISO 14001:2015, pointing out some of the common pitfalls for organizations in transition or implementation and preparing for third-party audit. |
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Understanding the US Food Safety Modernization Act
Find out how to prepare for the FSMA with our white paper, including a step-by-step process guide. |
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Mitigating the Risk of Mid-Air Collisions with Remotely Piloted Aircraft Systems
We look at areas of improvement for both manned and unmanned flight operations to mitigate the risks of mid-air collisions between Remotely Piloted Aircraft Systems and commercial air traffic. |
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Utilizing Data and Key Performance Indicators to Successfully Execute a Phase III Influenza Treatment Clinical Trial
This paper will address how SGS utilized constant data tracking to mitigate the disease-specific challenges and successfully execute a Phase III clinical trial in influenza patients. |
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Retailers: Understanding the Risks of Global Supply Chains
We present an investigation into supply chain complexity, considering how to reduce risk for retailers. |
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A Consideration of H1N1/09pdm and New Variant H3N2/13 as Agents for Human Challenge Trials
Within the field of influenza research, there is becoming an increasingly large place for Human or Viral Challenge Trials (HCT). |
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Sputum Induction Method to Optimize Respiratory Patient Clinical Trials
This white paper will examine the use of sputum induction as a pharmacodynamic method to optimize respiratory patient clinical trials, including comparison to other methods, and a case study looking at asthma patients and healthy volunteers. |
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Early Phase Clinical Trials in Patients with Hepatic or Renal Impairment
FDA and EMA guidances are intended to help companies evaluate the need for conducting PK studies in renal and hepatic impaired patients. Although many procedural recommendations exist, some key questions still need to be investigated case-by-case at the early stage of the project development. |