A Comprehensive Textbook On Product Development And Technology Transfer
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A Comprehensive Textbook on Product Development and Technology Transfer
This textbook serves as a comprehensive academic resource for postgraduate, and research scholars, faculties and students, pharmaceutical professionals, and industry researchers involved in formulation development, regulatory affairs, and manufacturing processes. The book provides an in-depth understanding of the entire journey of a pharmaceutical product, from conceptualization and laboratory-scale formulation to its eventual large-scale manufacture and commercialization. A major focus is placed on the critical stages of product life cycle management, regulatory strategies, clinical evaluation, and technology transfer procedures—bridging the gap between R&D and commercial manufacturing.
Text Book of Product Development and Technology Transfer
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.
A Textbook of INDUSTRIAL PHARMACY-II
Author: Dr. Akhila A. R., Mrs. Patibandla. Jahnavi , Dr. Y. Ratna Sindhu , Mr. Rohit Arora , Mr. Surender
language: en
Publisher: Shashwat Publication
Release Date: 2025-07-17
Introducing the book "Industrial Pharmacy-II" is something that fills me with an incredible amount of joy. The content of this book has been meticulously crafted to adhere to the curriculum for Bachelor of Pharmacy students that has been outlined by the Pharmacy Council of India. An effort has been made to investigate the topic using terminology that is as straightforward as possible in order to make it more simply digestible for pupils. The book has a number of illustrations, such as flowcharts and diagrams that make it simple for students to comprehend complex ideas. It is the author's honest desire that both students and academicians would take something helpful away from reading this book.