|Comparison of Dissociated Phoria Measuring Methods. Repeatability and Reliability|
Ane Murueta-Goyena Larrañaga
The aim of this study is to determine the reliability and compare reproducibility of different dissociated phoria measure tests.
|Secondary Prevention of Stroke: The role of the General Practitioner|
This study aims to review the literature to further elucidate the potential impact of primary care physicians in reducing the burden of stroke.
|Participation in “The Airways Program” (TAP) and Associated Mortality Reduction|
Pradeep Paul George, Bee Hoon Heng, Mavis Yeow Bee Ling, Loo See Yeow, Fong Seng Lim, Lim Tow Keang
Research objectives were to assess the impact of “The air way program” on patients length of stay, readmission and mortality.
|Random Homozygous Gene Perturbation (RHGP) as a Tool for Target Discovery and Validation|
Wu-Bo Li and Michael Goldblatt
Random homozygous gene perturbation (RHGP) can identify and validate any host (cellular) gene target that directly causes a desired phenotype without requiring prior knowledge of the target. The central feature of RHGP is a unique lentiviral-based genetic element, known as a gene search vector (GSV) designed to interrogate the entire genome and identify target genes that cause the phenotype of interest.
|Gene expression analysis of CD14+ monocytes immunomagnetically separated directly from whole blood: adaptation of protocols towards clinical trial requirements|
Gregor Winkels1, Ines Dischinger1, Katharina Bublitz1, Evert Luesink2, Nanguneri R. Nirmala2, Frank Staedtler2, Keith J. Johnson2, Alena Fitz1, Sabrina Schmitz1, Dirk Dietrich1, Sonja Balzer1, Sabine Classen1, Silvia Rüberg1, Uwe Janssen1, and Bernhard Gerstmayer1
Peripheral blood is widely used as starting material for biomarker discovery and validation using molecular biology technologies. The vast majority of currently published transcriptome data is based on RNA derived either from stabilized whole blood or peripheral blood mononuclear cells (PBMCs). Here, gene expression profiling studies and SOPs for fast, easy and specific manual or automated isolation of monocytes directly from whole blood are being described.
|Quality Standards for 14C API for use in human clinical studies|
I Shaw, G Johnston, K Dare, D Dams
The Good Manufacturing Practice (GMP) state that the active pharmaceutical ingredient (API) intended for use in early stage clinical trials should be of "suitable" quality. The Clinic Ready quality standard ensures that the API is synthesised with all the appropriate documentation to facilitate QP release of the final IMP for guman clinical dosing.
|LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes|
Richard Clayton, Caroline Anderson, Brian Morrison and Lindsay Corfield
Following publication of the FDA MIST guidelines and revision of ICH M3, there is increasing interest in obtaining metabolic profiling data at an early stage in the development of a drug. This has led to a requirement to estimate the relative abundance of metabolites in samples prior to the synthesis of the radiolabelled compound and from a wider range of studies.
|Fast PK and Semi Quantitative Analysis of Metabolites Using High Resolution MS|
Rohan A. Thakur and Mike Koleto
It has become essential to eliminate poor candidates as early as possible in the drug development process. This realization led to the application of high throughput principles to the in vivo Lead Optimization process, wherein the NCE is first given to rodents to determine the PK profile in a rapid and limited study. This rapid primary screen is known as Fast PK and several critical decisions are based on this initial study.
|How to Produce and Validate an IND Report / Validation Report in Just a Few Days|
Dr Paul Denny-Gouldson, Simon Beaulah
How to Produce and Validate an IND Report / Validation Report in Just a Few Days The IDBS E-WorkBook Suite is an enterprise, data-centric ELN designed to support validated experiment data and IP capture for the entire large and small molecule preclinical development environment. It enables data required for experiments and reports to be captured, stored and searched in a consistent manner across all departments.
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