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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.

Tobacco use in asbestos workers
T.Medveczky, C.Turton

Asbestos related lung disease is likely to increase. Smoking, apart from being the major risk factor for lung cancer, may be a co-factor in the development of asbestos in lung disease. The Health and Safety Executive report mentions the high rate of smokers in asbestos related industry (1). We have reviewed our local population of asbestos workers to explore that further.

Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation
Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation

A new method of administration of bone marrow derived mononuclear cells (BMMCs) was studied using the model of acute myocardial infarction in rats. The transplanted cells were detected only in the scar tissue and had fibroblast-like phenotype. They differentiated neither into cardiomyocytes nor into the cells of blood vessels.

Protein array-based screening of autoantibody signatures
Zingaretti C., Arigò M., Colombatto P., Brunetto M., Muratori L., Bonino F., Bianchi F., Pagani M., De Francesco R., Abrignani S., Bombaci M.

The evidence for an association between autoimmune diseases and chronic HCV infection has been clearly established. To this aim, a protein array was employed to analyze serum samples of HCV patients w/wo autoimmune complications, of patients with autoimmune hepatitis but not infected with HCV and of healthy donors as controls. A panel of autoantigens able to discriminate among the three groups of patients was identified for potential use as biomarkers.

Clinical Evaluation of induced pluripotent stem cells (iPSc) to cure patients with Psoriasis Vulgaris. An Open Study.
Timothy S. Andersson, David K. Chin, Wendy H. Wong

To evaluate the clinical efficacy of iPSc directed to interfere T-cell activation to cure patients with psoriasis. Twenty subjects were enrolled. Each patient was administered iv with syngenic iPS. Those showing lower PASI score were considered cured. The study states that induced iPSCs are safe and impart significant clinical efficacy to cure patients with psoriasis.

Ethnicity and Help-seeking
Kyle L. Gravel¹, Christina J. Sun², Nana Sadamura¹, Erin Moniz¹

Ethnic minorities have traditionally underutilized mental health services. It has been proposed that both willingness to see a counselor and attitudes towards seeking psychological help may impact utilization of psychological services among ethnic minority populations. The aim of this study was to explore the relationship between willingness to see a counselor and attitudes toward seeking psychological help among college students.

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Scientific News
NIH-supported Clinical Trials to Evaluate Long-acting, Injectable Antiretroviral Drugs
Both trials are expected to be completed in 2017.
Single-Cell, 42-plexed Protein Analysis Achieved with a New Microchip Technology
A novel microdevice capable of detecting 42 unique immune effector proteins has been developed.
Paramedics May be First Line of Treatment for Stroke
NIH study demonstrates feasibility of getting drugs to stroke patients faster.
Cancer Treatment with KU Origins Enters Second Clinical Trial
Cleave Biosciences has begun a Phase 1 clinical trial to evaluate CB-5083.
Ebola Vaccine Trial Opens in Liberia
Study led by Liberia-NIH partnership will test two experimental vaccines.
NIH Launches Tool to Advance Down Syndrome Research
Web portal will help approved professionals to plan clinical studies.
NIH Researchers Tackle Thorny Side of Gene Therapy
Pre-clinical studies in mice reveal ways to reduce cancer risk with modified treatment.
Early Blood Glucose Control Lengthens Life in People with Type 1 Diabetes
Reductions in diabetes complications resulting from tight glucose control translate into longer lifespans.
Oxford Vaccine Group Begins First Trial of New Ebola Vaccine
Oxford University doctors and scientists are starting the first safety trial of an experimental preventative Ebola vaccine regimen being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen).
GRP78 Protein Possible Universal Therapeutic Target
Drug combination including Viagra is effective tool in targeting the protein.
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