Books in Pharmaceutical quality control

Handbook of Pharmaceutical Wet Granulation

2nd Edition
November 1, 2025
Ajit S. Narang + 1 more
English

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm, Second Edition offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. This completely revised and updated edition features five new chapters covering new AI tools applied to scaling up granulation processes, model drive design, machine learning models for granule property prediction, design and scale up of fluid bed granulation, and process analytical methods. This book is the prefect reference for pharmaceutical manufacturing professionals. Academic researchers will benefit from the practical advice provided by the editors and chapter authors.

Sustainability in the Manufacturing of Pharmaceuticals

1st Edition
October 1, 2025
Dimitrios A. Lamprou
English

Sustainability in Pharmaceutical Manufacturing is a groundbreaking reference for the pharmaceutical industry. Currently lagging behind other manufacturing sectors, pharmaceutical production requires significant changes in areas such as manufacturing methods, waste management, packaging, and supply chain. This book compiles cutting-edge research from leading global experts, offering scientific insights and innovative strategies to revolutionize sustainability in pharmaceuticals. It explores the transformative potential of the circular economy, lifecycle management, and resource optimization for maximum efficiency and minimal environmental impact.The book delves into green chemistry, highlighting alternative solvents and methods for drug production. It emphasizes novel microfluidic and additive manufacturing techniques, utilizing bio-based sustainable polymers and materials. Chapters on greener drug discovery, development, and scaling processes provide the most current research at each production stage. This invaluable resource enables researchers in academia and industry to make informed choices, enhancing their manufacturing practices and shaping the future of sustainability in the pharmaceutical sector.

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

2nd Edition
August 1, 2025
Tim Sandle
English
Hardback
9 7 8 0 4 4 3 3 6 4 3 6 5
eBook
9 7 8 0 4 4 3 3 6 4 3 7 2

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Second Edition is a comprehensive guide that navigates the complex world of pharmaceutical sterilisation. This new edition is updated to reflect the latest standards and regulations, ensuring the book remains aligned with current approaches. The book also explores emerging sterilisation methods, providing readers with the most up-to-date techniques in the field. Additionally, the inclusion of new case studies offers practical examples that aid in the understanding and application of these sterilisation methods. The failure to control any microbial challenge within a process or product can lead to a contaminated marketed product, potentially causing harm to patients. Hence, sterilisation is of critical importance to healthcare and the manufacturing of medical devices and pharmaceuticals. This edition covers a wide range of topics including sterility, sterilisation and microorganisms, pyrogenicity and bacterial endotoxins, regulatory requirements and good manufacturing practices, and different sterilisation methods such as gamma radiation, e-beam, dry heat, steam, gas, vapour, filtration, and new sterilisation techniques. It provides a thorough examination of sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, container and packaging design, and cleanroom environments. The new edition also introduces substantial additions such as X-ray sterilization, liquid-phase sterilization, ultraviolet light, supercritical gases, and sterilisation assurance governance. Each chapter has been updated to reflect the latest changes in the field. "Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations" is an indispensable resource for those involved in the manufacturing of sterile products. Its comprehensive coverage of sterilisation methods, combined with practical case studies, provides readers with a robust understanding of sterilisation technology and its application. The book will be of great value to those in pharmaceuticals, healthcare, and medical device manufacturing, providing them with the knowledge to ensure their products are safe and compliant with current standards and regulations.

Health Literacy in Medicines Use and Pharmacy

1st Edition
November 27, 2024
Ahmed Awaisu + 4 more
English
Paperback
9 7 8 0 1 2 8 2 4 4 0 7 4
eBook
9 7 8 0 3 2 3 8 5 9 7 1 4

Health Literacy in Medicines Use and Pharmacy: A Definitive Guide highlights issues related to medication literacy from the context of the pharmacist and other healthcare professionals. This definitive guide will undoubtedly serve as an invaluable resource for healthcare professionals in training and practice, fostering excellence in patient care globally. The book provides a clear explanation of medication literacy, presents different tools to assess health and medication literacy, readability, and comprehensibility of written medicine information (WMI), and elaborates on different approaches to develop customized and patient-friendly WMI. The book also covers health and medication literacy in special populations, including geriatrics, pediatrics, and pregnant/lactating patients. Written by experts in health communication, this book will help pharmacists, other health professionals, educators, students, and regulators, who need to develop customized educational materials that can be understood by a broad range of patients, especially those with low health literacy.

Fundamentals and Future Trends of 3D Printing in Drug Delivery

1st Edition
November 20, 2024
Dimitrios A. Lamprou + 1 more
English
Paperback
9 7 8 0 4 4 3 2 3 6 4 5 7
eBook
9 7 8 0 4 4 3 2 3 6 4 6 4

Fundamentals and Future Trends of 3D Printing in Drug Delivery provides readers with all needed information for their journey from ideation to approval of innovative drug delivery devices produced through additive manufacturing.This book provides an in-depth discussion on key factors affecting the printing process such as different printer technologies, materials selection, resolutions, temperatures and speeds. Dedicated chapters include specific drug delivery devices in the form of oral solid dosage, implants, catheters and vascular grafts, and microneedles. The prospects of 3D printing associated with personalized medicine are covered in a full chapter.Fundamentals and Future Trends of 3D Printing in Drug Delivery is the perfect reference for any researcher or professional embarking on a 3D printing process for drug delivery devices. The regulatory aspects included are of particular interest to companies entering this promising market.

Biocontamination Control for Pharmaceuticals and Healthcare

2nd Edition
January 28, 2024
Tim Sandle
English
Paperback
9 7 8 0 4 4 3 2 1 6 0 0 8
eBook
9 7 8 0 4 4 3 2 1 6 0 1 5

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Computer-Aided Applications in Pharmaceutical Technology

2nd Edition
September 7, 2023
Jelena Duris
English
Hardback
9 7 8 0 4 4 3 1 8 6 5 5 4
eBook
9 7 8 0 4 4 3 1 8 6 5 6 1

Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more.

Evidence-Based Validation of Herbal Medicine

2nd Edition
July 12, 2022
Pulok K. Mukherjee
English
Paperback
9 7 8 0 3 2 3 8 5 5 4 2 6
eBook
9 7 8 0 3 2 3 9 8 4 5 6 0

Evidence-Based Validation of Herbal Medicines: Translational Research on Botanicals brings together current thinking and practice in the characterization and validation of natural products. The book describes different approaches and techniques for evaluating the quality, safety and efficacy of herbal medicine, particularly methods to assess their activity and understand compounds responsible and their probable underlying mechanisms of action. This book brings together the views, expertise and experiences of scientific experts in the field of medicinal plant research, hence it will be useful for researcher who want to know more about the natural lead with their validation and also useful to exploit traditional medicines.

Regulatory Affairs in the Pharmaceutical Industry

1st Edition
November 14, 2021
Javed Ali + 1 more
English
Paperback
9 7 8 0 1 2 8 2 2 2 1 1 9
eBook
9 7 8 0 1 2 8 2 2 2 2 3 2

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

Remington

23rd Edition
October 30, 2020
Adeboye Adejare
English
Hardback
9 7 8 0 1 2 8 2 0 0 0 7 0
eBook
9 7 8 0 1 2 8 2 2 3 8 9 5

The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics.

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