Determining Adversity in Toxicology Studies – A Toxicologist’s Perspective

Conference Talk by Dr. Venkatesha Udupa

Dr Venkatesha Udupa, Senior GM – Toxicology, Glenmark Pharmaceuticals Limited

Talk Abstract: A biochemical, morphological or physiological change (in response to a stimulus) that either singly or in combination adversely affects the performance of the whole organism or reduces the organism’s ability to respond to an additional environmental challenge is called ‘adverse effect’ in a repeat dose toxicology studies.

Adversity assessment represents empirical measurements (i.e., objective data), and integrated with well-informed subjective and professional judgments, and consequent designation of the No Adverse Effect Level (NOAEL) is the pivotal endpoint of repeat dose toxicology studies in animals which require analysis of results of all parameters evaluated in the particular study.  Differences in approaches and opinions related to using adverse effect data and NOAEL affect the assessment of human risk by regulators who may apply more conservative approaches to human dosing than otherwise necessary with better-prepared discussion and application of the concepts of adversity.

Clarity achieved through more consistent and transparent application of the adversity concept within nonclinical reports will improve communications in regulatory submissions, benefitting both clinicians and regulators charged with protecting human health. It is the ultimate responsibility of each organization to ensure that toxicology study documents and nonclinical overview regulatory documents for a given product include clear and cohesive interpretation of study findings, adversity and their relevance to humans.

Dr Venkatesha will be speaking at Metabolomics India 2017 in Hotel LeMeridien, Bengaluru.



Nuclear Magnetic Resonance Based Metabolomics for the Biomarker Discovery in Gallbladder Cancer and Acute Respiratory Distress Syndrome (ARDS)

Neeraj Sinha
Neeraj Sinha, Addl. Professor, Sanjay Gandhi PGIMS, India

Conference Talk by Dr Neeraj Sinha

Talk Abstract: Nuclear Magnetic Resonance (NMR) and Mass Spectrometry (MS) based spectroscopic techniques has become an indispensable tool for the metabolomics study in recent years. While the sensitivity of MS based methods are more than NMR spectroscopy, there are many advantages with NMR based metabolomics study. NMR provide advantages such as high reproducibility, least sample preparation procedure, and accuracy in quantitative estimates of the metabolites. Typical biofluids such as serum, urine, whole blood cell, bronchoalveolar lavage fluid (BALF) etc can be subjected to NMR spectroscopy for accurate detection of metabolites. The multiparametric response to the system can be mapped in terms of NMR spectral density. The interpretation of these responses can give insight into the metabolic cycle of the disease condition. Taking this into account, Dr. Sinha has developed various methods in CBMR laboratory for gallbladder cancer, acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).

Dr Neeraj Sinha will be speaking at Metabolomics India conference in Bengaluru on September 15, 2017.

How to choose right tool to implement 3D Cell-based Assays?

 The Implementation of 3D Cell based Assays and High Content Imaging in Translational Research: Choosing the right tools for the Job

High Content Screening and analysis (HCS/A) technologies have over the last 15 years become widely adopted in both the academic and industrial research sectors. The acceptance of these technologies has in the large part been due to their demonstrable utility as both drug-discovery and basic research tools, indeed these imaging technologies such as HCS/A have the capability of providing researchers with a ready means of performing both large scale primary screens as well as permitting more detailed downstream analysis.  Alongside the rapid uptake of these technologies, we have also seen a concomitant increase in the demand for more refined and flexible hardware and biologically relevant cell based assay approaches that can be utilized for translational research.  Currently one of the biggest drivers in the field is the need to improve the physiological relevance of cell based assays used within translational research campaigns. To achieve these aims many are turning their attention to the use of primary cells and/or 3 dimensional cellular assay models. In summary this presentation will cover the key technological and methodological approaches we are currently implementing within our High Content Analysis workflows to meet our translational research goals. This talk will be presented at CellTech India 2015 in Bangalore on March 2, 2015 by Dr. Anthony Mitchell Davies, Queensland, Australia. Dr. Anthony Mitchell Davies is currently the Center Director: Translational Cell Imaging, Institute of Health Biomedical Innovation, Australia

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