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Morimoto B.H.,Celerion Inc | Castelloe E.,Erin N Castelloe | Fox A.W.,Kings College London
Handbook of Experimental Pharmacology | Year: 2015

Safety pharmacology is essential throughout the spectrum of drug discovery and development. Prior to first-in-human studies, safety pharmacology assays, tests, and models predict the clinical risk profile of a potential new drug. During clinical development, safety pharmacology can be used to explore—and potentially explain—both predicted and unpredicted side effects (e.g., adverse events, changes in vital signs, abnormal laboratory values) in order to refine the original clinical risk profile. This chapter will introduce the reader to safety pharmacology’s role in translational medicine: the science of translating potential drugs’ on- and off-target nonclinical properties to clinical consequences in order to select the best drug candidates to move into early clinical testing. Case studies will be used to illustrate the importance of safety pharmacology testing throughout all phases of drug development. © Springer-Verlag Berlin Heidelberg 2015. Source


Beaver C.J.,PharmaNet Canada Inc. | Roby-Peters S.K.,Celerion Inc
Bioanalysis | Year: 2011

Large-molecule drugs (therapeutic proteins, peptides, various forms of antibodies) are more frequently being seen in drug-development pipelines, the majority of which are measured using immunochemical/ligand-binding techniques. The assays utilized for analysis of large-molecule drugs rely heavily upon the quality of the components (e.g., reference materials, antibodies) that are critical to the performance of the assays. Commercially available research-grade materials and kits offer a convenient and simple solution, but also present some unique challenges. This article will explore some examples of issues encountered while employing commercially available kits and reagents. © 2011 Future Science Ltd. Source


Tyl B.,Robert Ballangers Hospital | Azzam S.,Celerion Inc | Blanco N.,Clearstone Central Laboratories | Wheeler W.,Celerion Inc
Journal of Electrocardiology | Year: 2011

Background: Newer algorithms for automated QT interval measurements may be more reliable than previous algorithms. Objective: This study compares Bazett-corrected QTc obtained by an older algorithm (Old12SL) and by 2 newer ones (New12SL and v3.19) to semiautomated measurement performed by experienced cardiologists. Methods: A total of 6105 randomly selected electrocardiograms were classified by the cardiologists as normal (4227), borderline (1254), abnormal (575), or not analyzable (49). Errors of automated measurement were defined by more than 30 milliseconds of absolute difference between Bazett-corrected QTc obtained by automated algorithms and semiautomated measurement. Results: The Old12SL had approximately twice as many errors (5.25%) as the New12SL (2.33%) and v3.19 (2.30%), P < .0001. Abnormal tracings resulted in more errors than did normal ones (Old12SL: 16.52% vs 3.45%, New12SL: 7.30% vs 1.51%, and v3.19: 10.61% vs 1.21%). Conclusion: Newer automated algorithms for QT measurements are highly reliable in normal tracings. However, electrocardiogram abnormalities increase the risk of QT measurement errors. © 2011 Elsevier Inc. Source


Mendell J.,Daiichi Sankyo | Lee F.,Celerion Inc | Chen S.,Daiichi Sankyo | Worland V.,Celerion Inc | And 3 more authors.
Journal of Cardiovascular Pharmacology | Year: 2013

Edoxaban is an oral factor Xa (FXa) inhibitor in clinical development for stroke prevention in patients with atrial fibrillation, an elderly population that frequently receives aspirin (ASA) and/or nonsteroidal anti-inflammatory drugs for concurrent illnesses. Three studies were conducted to evaluate the pharmacokinetic and pharmacodynamic interactions of edoxaban 60 mg coadministered with low-dose (100 mg) ASA, high-dose (325 mg) ASA, or naproxen (500 mg) in healthy subjects (n = 126). Template bleeding times (BT) were measured. Mean baseline (predose) BT for the 3 studies ranged from 4.72 to 6.13 minutes. Edoxaban administered alone increased BT by 21%-35% (4 hours post dose) from baseline. Concomitant administration of edoxaban with high-dose ASA, low-dose ASA, or naproxen increased BT approximately 2-fold showing an additive effect greater than either agent administered alone. Edoxaban pharmacokinetics were not affected by concomitant low-dose ASA or naproxen, but high-dose ASA increased systemic exposure of edoxaban by approximately 30%. The effects of edoxaban on prothrombin time, activated partial thromboplastin time, international normalized ratio, anti-FXa, and intrinsic FXa activity were not influenced by administration with ASA or naproxen. Inhibition of platelet aggregation by high-dose ASA, low-dose ASA, or naproxen was not affected by edoxaban. Concomitant administration of edoxaban and ASA or naproxen was well tolerated. © 2013 by Lippincott Williams & Wilkins. Source


Today's bioanalytical CROs face increasing global competition, highly variable demand, high fixed costs, pricing pressure, and increasing demand for quality and speed. Most bioanalytical laboratories have responded to these challenges by implementing automation and by implementing process improvement methodologies (e.g., Six Sigma). These solutions have not resulted in a significant improvement in productivity and profitability since none of them are able to predict the upturn or downturn in demand. High volatility of demand causes long lead times and high costs during peak demand and poor productivity during trough demand. Most bioanalytical laboratories lack the tools to align supply efficiently to meet changing demand. In this paper, sales and operation planning (S&OP) has been investigated as a tool to balance supply and demand. The S&OP process, when executed effectively, can be the single greatest determinant of profitability for a bioanalytical business. Source

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