US food and drug administration Indian site inspections: An experience

Since 2005, USFDA has begun inspections of Indian clinical trial investigator sites. This paper reports experience of an FDA inspection performed at two Indian centers. The inspection started with an in-depth discussion with the investigator and his team about the conduct of the clinical trial at the site and was followed by a tour of the important locations - registration, outpatient department, specialty clinic, medical record section, and special procedure department. The inspector reviewed the critical processes - protocol compliance, ethics committee approval, informed consent process, case record form and source documents completion, investigational product accountability, serious adverse events documentation and reporting. The inspector reviewed all documents from the investigator site file and conducted audit of all subjects enrolled at both the sites. As the Indian sites are not exposed to regulatory inspections, it is vital for the sponsor to conduct preinspection audit, provide training and support to face the FDA inspection

Forward and reverse mapping for milling process using artificial neural networks

The data set presented is related to the milling process of AA6061-4.5%Cu-5%SiCp composite. The data primarily concentrates on predicting values of some machining responses, such as cutting force, surface finish and power utilization utilizing using forward back propagation neural network based approach, i.e. ANN based on three process parameters, such as spindle speed, feed rate and depth of cut.The comparing reverse model is likewise created to prescribe the ideal settings of processing parameters for accomplishing the desired responses as indicated by the necessities of the end clients. These modelling approaches are very proficient to foresee the benefits of machining responses and also process parameter settings in light of the experimental technique. Keywords: ANN, Forward mapping, Reverse mapping, Milling proces

Grey matter volume differences associated with extremely low levels of cannabis use in adolescence

Rates of cannabis use among adolescents are high, and are increasing concurrent with changes in the legal status of marijuana and societal attitudes regarding its use. Recreational cannabis use is understudied, especially in the adolescent period when neural maturation may make users particularly vulnerable to the effects of Δ-9-tetrahydrocannabinol (THC) on brain structure. In the current study, we used voxel-based morphometry to compare grey matter volume (GMV) in 46 fourteen year old human adolescents (males and females) with just one or two instances of cannabis use and carefully matched THC-naïve controls. We identified extensive regions in the bilateral medial temporal lobes as well as the bilateral posterior cingulate, lingual gyri, and cerebellum that showed greater GMV in the cannabis users. Analysis of longitudinal data confirmed that GMV differences were unlikely to precede cannabis use. GMV in the temporal regions was associated with contemporaneous performance on the Perceptual Reasoning Index and with future generalized anxiety symptoms in the cannabis users. The distribution of GMV effects mapped onto biomarkers of the endogenous cannabinoid system providing insight into possible mechanisms for these effects.Almost 35% of American 10 graders have reported using cannabis and existing research suggests that initiation of cannabis use in adolescence is associated with long-term neurocognitive effects. We understand very little about the earliest effects of cannabis use, however, as most research is conducted in adults with a heavy pattern of lifetime use. This study presents evidence suggesting structural brain and cognitive effects of just one or two instances of cannabis use in adolescence. Converging evidence suggests a role for the endocannabinoid system in these effects. This research is particularly timely as the legal status of cannabis is changing in many jurisdictions and the perceived risk by youth associated with smoking cannabis has declined in recent years