The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the …
Measuring Extracellular pH Within Tumors Using CEST MRI
pH is one of the key microenvironmental factors in the development of tumors. Tumor cells are often viewed as high lactate and H+ producers.1 Extracellular acidosis represents a threat to cell survival by modifying the intracellular pH (pHi), wherein a 0.1 pHi variation can disrupt multiple biological functions.2 Measurements of tumor extracellular pH …
TQT Waivers: One Year Later
Overcoming Design Challenges ICH E14 REGULATORY GUIDANCE 2005 AND 2015 It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a …