Bilateral superficial cervical plexus block may help in reduction of postthyroidectomy pain.

Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety. Efforts toward the early detection of drug safety issues are minimal. There is no mandate to publicly disclose drug safety findings. Benefit-risk evaluation of investigational and marketed products cannot be assured merely through annual status reports and periodic safety update reports, respectively. Focused initiatives involving stakeholders from regulatory, health-care, and pharmaceutical industries are required to change the current situation and enable derivation of meaningful insights from safety data. Equal emphasis on assessing real-time safety of the drugs and protection of patients' rights, safety, and well-being is required. Periodic safety data reporting in clinical trials, proactive safety data collection related to potential safety concerns, electronic medical records, electronic expedited reporting, collection of targeted data from stakeholders, and standardized and harmonized data collection aligned to the International Council for Harmonization guidelines are required. The Central Drugs Standard Control Organization should implement requirements to submit Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Risk Management Plans. Access to clinical trials and postmarketing safety data through central repository would enable researchers to explore the data for application in clinical practice.

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An in vivo animal model was developed to study the effects of voluntary eccentric, concentric, and isometric muscle actions and varying work-rest cycles on muscle performance, behavior, and histological and biochemical response. Using a custom-designed apparatus that was attached to a standard operant chamber, rats were operantly conditioned with food rewards to perform a voluntary lifting task to generate controlled movement of the plantar flexors. An opening in the front panel of the operant chamber allowed the rat to enter a Plexiglas tube that was mounted vertically to restrict the movement of the rat. A load cell was embedded in a platform at the bottom of the tube to measure the dynamic force exerted by the plantar flexors. Inside the tube, a neck ring was supported by a yoke that moved along two vertical shafts via linear bearings. A displacement transducer (LVDT) was attached to the weight pan to measure the range of motion of the lift, and allowed determination of velocity and acceleration of the lifting motion. The apparatus allowed the rat to enter the tube through the opening, insert its neck into the ring, and lift the ring assembly. The entire process was computer automated, and vertical displacement, time during each lift, and dynamic forces exerted during each lift were sampled at 100 Hz via a computer-controlled data acquisition system. This apparatus allows skeletal muscle performance to be studied longitudinally and in a controlled biomechanical environment. The apparatus is well suited to study the effect of chronic voluntary muscle actions and work-rest cycles on behavior and physiological outcomes. iii ACKNOWLEDGEMENTS I take this opportunity to thank and show my appreciation to everyone who has had a role to play during my graduate career at West Virginia University. I would like to thank my research advisor Dr. Ahluwalia also the chair of the committee, without whose encouragement and guidance this thesis would not have been possible. To Dr. Cutlip, who accepted me on this project and advised me throughout my research work. Also, for his patience and the time he spent in developing my bioengineering skills and honing my engineering skills. To Dr. McMullin for serving on my committee and the advice and encouragement she provided. iii Table of Contents iv List of Tables vi List of Figures vii 1.