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TEXT BOOK OF PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER

Author Name: Dr. Manoj Kumar Katual | Format: Hardcover | Genre : Educational & Professional | Other Details

The drug discovery and development process is a complex, multi-faceted journey that begins with the identification of potential therapeutic targets and culminates in the approval and marketing of new medications. This process involves several critical stages, including the discovery phase, preclinical research, clinical trials, and regulatory approval. During the preclinical stage, rigorous pre-formulation studies assess the organoleptic properties, purity, impurity profiles, particle size, shape, surface area, and solubility of drug candidates. These studies are essential for understanding the physicochemical characteristics of the drug and for developing methods to enhance solubility, such as using surfactants or co-solvents. The transition from laboratory-scale to commercial-scale production, known as pilot plant scale-up, requires careful planning, design, and execution to ensure that the manufacturing processes are scalable and that the quality and stability of the drug are maintained. Pharmaceutical packaging plays a crucial role in protecting the drug product, ensuring its stability, and facilitating its safe and effective use. Packaging materials must be carefully selected, evaluated, and tested for quality control to meet regulatory standards. Technology transfer from research and development to production involves optimizing processes, ensuring consistent product quality, and thorough documentation to support regulatory submissions. 

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Dr. Manoj Kumar Katual

Dr. Manoj Kumar Katual is Head & Associate Professor in Pharmacy at Guru Kashi University, Bhatinda, Punjab. He completed his D.Pharmacy, B.Pharmacy, M.Pharmacy, M.B.A, PhD. He is having rich experience of more than 16 years in academics and 1year in Industry. He has authored of 14 text books in Pharmacy, Paramedical & allied Sciences and Nursing.  He has published more than 135 research papers in various national and international journals of repute with good impact factors. He has 6 Research Patents.  Till yet, he has received  prestigious “Young Scientist Award” for Science & Medicine ,“InSc  Young Achiever Award (YAA)”, “Plantica Excellence Research Fellow Award”, “Best Faculty award” Academics, “Young Faculty Award”. India. He is the Ambassador of Prestigious ‘Bentham Science Publishers” due to his high quality paper publication. He guided more than 40 students of M.Pharmacy for their research work. He delivered many guest lectures in various institutes as expert. His core area of research are Novel drug delivery systems, Nanotechnology, Nanoparticles and CNS targettin

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