Clinical trial is a part of clinical research. It is a systematic experimental biomedical study. They are carried out to evaluate the effectiveness and safety of medications or medical devices or biologics. Trials are conducted to check safety and efficacy of new drug. It includes four phases as phase I, II, III, and IV. The study is carried out according to study protocol and standard operating procedures as per good clinical practices guidelines. The study protocol is developed by the researchers and approved by an independent committee called as Institutional Review Board. Protocol is a roadmap for team of healthcare professionals involved in investigation work. It should explain the significance of research trial, location, detail procedure, methods, activities, time allotment, financial estimate and any other information required. The content of protocol are title, objective, background, eligibility criteria, study methodology, risks or adverse effects, benefits, alternative treatment, data collection, statistical treatment, regulatory guidance, and other information.
Six Sigma (6σ) is a process improvement methodology and can help in the betterment of the poultry industry. The steps are defined, measure, analyze, improve, and verify. It offers benefits like defect reduction and increased productivity. The new hypothesis is analyzed and improvements are tested and verified. Poultry is the most organized sector in animal agriculture in India, worth Euro 14,500 million. Poultry still has challenges and opportunities for improvement in productivity and quality standards. Six sigma can be applied to the poultry industry for continuous improvement and more economical benefits. The applications of 6σ to hatchery step in poultry may provide quality, uniformity, cost-effective process, minimum error, more customer satisfaction. The benefits offered are a reduction in egg damages, maintenance of egg quality, improvement in hatchability, improvement in hygiene, minimize microbial load and other inventories, improvement in capabilities and discipline of an employee, avoidance of backtracking. Six sigma applications to poultry industry need to be emphasized.
The purpose of the study was to compare and select optimum method for nanoparticles formulation in lung cancer therapeutics. For this experiment etoposide, anti-neoplastic agent was used as study molecule. The nanoparticles were prepared by methods like quassi emulsification solvent diffusion, high speed homogenization, probe sonication, magnetic stirring and compared. The batches for each method were prepared in different ratios of drug to polymers. All the formulated batches were evaluated for %EE, %DL, Particle size, polydispersity index and zeta potential. The method with better results was selected for further factorial model study. The batch with better results from 32 factorial model was investigated further for FTIR, DSC, XRD and drug release study. After comparing results of all the methods, method probe sonication with batch code C8 was found better. After applying factorial model, method with batch code F6 shown better results and showed no interactions between drug and polymer. % Drug release study showed almost two folds increased release. The probe sonication method was optimum method among all the methods. These formulated nanoparticles further can be incorporated in drug delivery for more efficient formulation in treatment of lung cancer.
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