Text Book Of Product Development And Technology Transfer
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Text Book Of Product Development And Technology Transfer
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Author : Dr Manoj Kumar Katual
language : en
Publisher: Notion Press
Release Date : 2024-07
Text Book Of Product Development And Technology Transfer written by Dr Manoj Kumar Katual and has been published by Notion Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07 with Education categories.
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 Comprehensive Textbook On Product Development And Technology Transfer
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Author :
language : en
Publisher: Shashwat Publication
Release Date : 2025-07-08
A Comprehensive Textbook On Product Development And Technology Transfer written by and has been published by Shashwat Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-07-08 with Education categories.
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 Industrial Pharmaycy Ii
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Author : Dr. Ritesh Kumar, Dr. Devendra Kumar Bhopte, Dr. D. Akila Devi, Anjali Naharwal, Dr. Vivekanand Katare
language : en
Publisher: Shashwat Publication
Release Date : 2025-06-21
Text Book Of Industrial Pharmaycy Ii written by Dr. Ritesh Kumar, Dr. Devendra Kumar Bhopte, Dr. D. Akila Devi, Anjali Naharwal, Dr. Vivekanand Katare and has been published by Shashwat Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-21 with Medical categories.
The Textbook of Industrial Pharmacy–II provides a comprehensive and structured insight into the critical aspects of industrial pharmaceutical practices. It begins with pilot plant scale-up techniques, highlighting the importance of scaling formulations from laboratory to production scale, covering personnel, space, raw materials, and regulatory documentation. Special attention is given to scale-up processes for various dosage forms such as solids, liquid orals, and semisolids, including compliance with SUPAC (Scale-Up and Post-Approval Changes) guidelines and the emerging role of platform technologies. The second unit, Technology Development and Transfer (TT), outlines WHO protocols for transferring pharmaceutical technologies from R&D to manufacturing. It details the roles of quality risk management, analytical method transfer, and validation. Important components such as API, excipients, packaging, and documentation are discussed, alongside legal frameworks including confidentiality agreements, licensing, and MoUs. The section also explores Indian TT agencies like APCTD, NRDC, and BCIL. Regulatory Affairs forms the third section, offering a historical perspective and an overview of global regulatory bodies. It emphasizes the function and responsibilities of regulatory professionals and the importance of their involvement across product lifecycle stages. The fourth chapter details the regulatory requirements for drug approval, addressing components such as INDs, NDAs, investigator brochures, non-clinical pharmacology, toxicology, and biostatistics. It also explains the management and design of clinical protocols, BE studies, and data presentation for FDA submissions. In the fifth section, Quality Management Systems are discussed extensively. Topics include Total Quality Management (TQM), Quality by Design (QbD), Six Sigma, Out of Specification (OOS) handling, change control, and compliance with ISO standards (9000 and 14000 series), NABL, and GLP practices. This ensures students understand how to maintain and evaluate quality at every stage of product development and manufacturing. Lastly, the textbook addresses Indian Regulatory Requirements, with a focus on the Central Drug Standard Control Organization (CDSCO) and State Licensing Authorities. It covers their structure, responsibilities, and role in issuing Certificates of Pharmaceutical Product (COPP), along with procedures for new drug approval in India. This well-organized content makes the textbook a valuable resource for students, educators, and professionals, bridging academic knowledge and industrial application.
A Textbook Of Industrial Pharmacy Ii
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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
A Textbook Of Industrial Pharmacy Ii written by Dr. Akhila A. R., Mrs. Patibandla. Jahnavi , Dr. Y. Ratna Sindhu , Mr. Rohit Arora , Mr. Surender and has been published by Shashwat Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-07-17 with Medical categories.
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.
Textbook Of Influenza
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Author : Robert G. Webster
language : en
Publisher: John Wiley & Sons
Release Date : 2014-01-06
Textbook Of Influenza written by Robert G. Webster and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-06 with Medical categories.
The Textbook of Influenza is a comprehensive resource covering all aspects of influenza, from the genetic and molecular biology of the virus through to clinical aspects of the disease and the latest drug developments and treatments. This new edition has been completely revised and reflects the integration of disciplines concerning the emergence, evolution, pathogenesis and control of influenza viruses in the field of human and veterinary public health. Textbook of Influenza examines the lessons learnt from the latest pandemic and provides the current state of knowledge for many yet unresolved issues related to virus origin, spread, pathogenesis and disease severity to better prepare for future pandemics. It covers the background to recent advances in influenza genomics and reverse genetics which have allowed the identification of virus virulence factors and the analysis and reconstruction of influenza viruses such as the 1918 Spanish flu strain. This new edition is divided into eight key sections, containing chapters co-written by international experts from both the clinical and scientific communities, covering: • Influenza Perspectives • Structure and Replication • Evolution and Ecology • Epidemiology and Surveillance • Immunology • Vaccines and Vaccine Development • Clinical Aspects and Antivirals • Public Health Textbook of Influenza is for all those working in the area of influenza including clinical and basic scientists, immunologists, molecular and structural virologists, public health officials and global pandemic control planners.
Technology Commercialization Manual
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Author : Melvin Joseph DeGeeter
language : en
Publisher: Med-Launch, Inc.
Release Date : 2004
Technology Commercialization Manual written by Melvin Joseph DeGeeter and has been published by Med-Launch, Inc. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Corporations categories.
Text Book Of Industrial Pharmaycy Ii
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Author : Dr. Ritu Gulia, Ms Poonam Sandhu, Ms. Tilottama Bhattacharya, Dr. Viram Parmar, Ms. Aditi Sharma
language : en
Publisher: Shashwat Publication
Release Date : 2025-05-20
Text Book Of Industrial Pharmaycy Ii written by Dr. Ritu Gulia, Ms Poonam Sandhu, Ms. Tilottama Bhattacharya, Dr. Viram Parmar, Ms. Aditi Sharma and has been published by Shashwat Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-20 with Fiction categories.
The Textbook of Industrial Pharmacy-II is a comprehensive guide tailored for students, researchers, and professionals engaged in the pharmaceutical industry, focusing on critical areas of drug manufacturing and regulation. It delves into pilot plant scale-up techniques, highlighting key factors such as personnel and space requirements, raw materials, and process adaptation from laboratory to industrial scale for solids, liquids, and semi-solids. The book emphasizes the importance of proper documentation and introduces SUPAC guidelines and platform technologies, which are essential for ensuring consistent quality and compliance. It also offers an in-depth discussion on technology development and transfer (TT), referencing WHO guidelines and addressing granular processes for APIs, excipients, packaging materials, and finished products. The documentation, equipment qualification, validation, and regulatory agency roles are thoroughly covered, including insight into Indian TT bodies like APCTD and NRDC. A dedicated section on regulatory affairs explores their evolution, functions, and the responsibilities of professionals in the field. It examines the steps involved in drug approval, starting from preclinical development through IND and NDA submissions, and stresses the significance of clinical protocols, biostatistics, and data presentation in gaining FDA approval. Furthermore, the book discusses quality management systems, detailing modern quality tools like TQM, QbD, Six Sigma, and standard systems such as ISO 9000, ISO 14000, NABL, and GLP, essential for ensuring regulatory compliance and product excellence. Lastly, it elaborates on Indian regulatory requirements, shedding light on the organizational structure and role of CDSCO and State Licensing Authorities, with a focus on obtaining the Certificate of Pharmaceutical Product (COPP) and navigating the approval procedures for new drugs. This book is a valuable academic and practical resource for understanding the multidisciplinary scope of industrial pharmacy and its regulatory landscape.
Chemical Engineering In The Pharmaceutical Industry
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Author : Mary T. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2019-04-08
Chemical Engineering In The Pharmaceutical Industry written by Mary T. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-08 with Technology & Engineering categories.
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Ultrasonic Guided Waves In Solid Media
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Author : Joseph L. Rose
language : en
Publisher: Cambridge University Press
Release Date : 2014-08-11
Ultrasonic Guided Waves In Solid Media written by Joseph L. Rose and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-11 with Medical categories.
Ultrasonic guided waves in solid media are important in nondestructive testing and structural health monitoring, as new faster, more sensitive, and economical ways of looking at materials and structures have become possible. This book can be read by managers from a "black box" point of view, or used as a professional reference or textbook.
Textbook Of Industrial Pharmacognosy
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Author : Dr Kumaraswamy Gandla
language : en
Publisher: BFC Publications
Release Date : 2023-03-18
Textbook Of Industrial Pharmacognosy written by Dr Kumaraswamy Gandla and has been published by BFC Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-18 with Medical categories.
Dr. Kumaraswamy Gandla (M.Pharm.Ph.D.) currently working as Professor and Head, Department of Pharmaceutical Analysis at Chaitanya (Deemed to be University), Hanumakonda, Telangana, India. He has published more than 25 patents, 4 Text Books published, 172 Research articles in national and international journals and also has presented & attended several national and International conferences. He guided more than 60 students B.Pharm. and M.Pharm. and few Research scholars pursuing Ph.D. under his supervision. He is an Editorial board member and regular reviewer in the editorial board for 75 national, International journals and also life member of Laboratory Animal Scientists' Association-India, (LASA), Association of Chemistry Teachers (ACT), & Indian Society of Analytical Scientists, Indian Society for Technical Education, Association of Pharmaceutical Teachers of India (APTI) and The Indian Pharmaceutical Association (IPA).