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Bioanalysis of Biosimilars
| By PRA Health Sciences
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.
Contract Research & Services > Contract Research > White Papers
ECG Assessments During the Development of Oncology Compounds
| By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
Contract Research & Services > Contract Research > White Papers
Truly Parallel - Microbiology
| By Eppendorf
DASGIP® Bioreactor Systems for Microbiology.
White Papers
Truly Parallel - Cell Culture
| By Eppendorf
DASGIP® Bioreactor Systems for Cell Culture Applications.
White Papers
Product Brochure: Most Compact
| By Eppendorf
DASbox® Mini Bioreactor System for Cell Culture and Microbiology.
White Papers
Product Brochure: The Smarter Solution
| By Eppendorf
BioFlo® 320 bioprocess control station.
White Papers
Translatability Assessment of the e-Health Impact Questionnaire
| By RWS Group
A study by researchers at the University of Oxford which demonstrates the importance of including a translatability assessment during the development of a questionnaire.
White Papers
The Challenges of Pilot Testing Translated PRO Measures with Children
| By RWS Group
Pilot testing measures in linguistic validation exercises with children poses a unique set of challenges. The methods for meeting these challenges and alternatives to pilot testing with children are the topics of this paper.
White Papers
ePRO Migration and Usability Testing of Patient-Reported Outcome (PRO) Measures.
| By RWS Group
A paper by PharmaQuest (a member of the RWS Group) and Isis Outcomes.
White Papers
Isothermal Titration Calorimetry: Theory and Practice
| By Malvern Instruments
Isothermal titration calorimetry (ITC) is an analytical technique that has become the "gold standard" for studying intermolecular interactions. As its name indicates, it is a titrimetric technique, that is, a volumetric laboratory method for quantitative chemical analysis (traditionally intended to determine the unknown concentration of an identified analyte) where a reagent solution, the titrant, is made to react with a solution of analyte or titrand.
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