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Bias, Conflict of Interest, Ignorance, and Uncertainty
Published in Ted W. Simon, Environmental Risk Assessment, 2019
The majority of high-throughput (HT) and high-content (HC) advanced screening techniques that are currently being applied in ToxCast™ were first developed for pharmaceutical purposes, and were adapted for screening of commodity and environmental chemicals. In the pharmaceutical industry, the assays are used to search for likely drug candidates with potent biological activities already predicted by computational methods such as quantitative structure–activity relationships (QSAR). In contrast, commodity chemicals are selected based their physicochemical properties, with the goal of improving the specific performance of a product—commodity chemicals typically possess much lower biological activity than do drug candidate molecules.
What to consider for a good quality PDE document?
Published in Pharmaceutical Development and Technology, 2019
Claudia Sehner, Markus Schwind, Gregor Tuschl, Ester Lovsin Barle
HBELs are substance-specific dose or concentration limits that are regarded as safe for the intended purpose and population under consideration. HBELs are set by different scientific/regulatory bodies/committees, like the World Health Organization (WHO), European Food Safety Authority (EFSA), Scientific Committee on Food (SCF), Agency for Toxic Substances and Disease Registry (ATSDR), Scientific Committee on Occupational Exposure Limits (SCOEL), or American Conference of Governmental Industrial Hygienists (ACGIH®), but also by enterprises. The substances considered mostly represent, e.g. commodity chemicals, metals, pesticides, biocides, or pharmaceutical compounds with a high likelihood of human exposure for example via air or as potential contaminants in drinking water or in foodstuffs. Depending on the purpose and route of exposure, the most common HBELs include acceptable/tolerable daily intakes (A/TDIs), ADE/PDEs, or occupational exposure limits (OELs).
Continuous flow technology vs. the batch-by-batch approach to produce pharmaceutical compounds
Published in Expert Review of Clinical Pharmacology, 2018
Kevin P. Cole, Martin D. Johnson
Traditionally, CM has been reserved for high-volume commodity chemicals. Throughput has not been viewed as a benefit for pharmaceutical production given that many companies enjoy an excess of legacy batch manufacturing capacity.