Water Activity Applications In The Pharmaceutical Industry

This second edition of Water Activity in Foods furnishes those working within food manufacturing, quality control, and safety with a newly revised guide to water activity and its role in the preservation and processing of food items. With clear, instructional prose and illustrations, the book’s international team of contributors break down the essential principles of water activity and water–food interactions, delineating water’s crucial impact upon attributes such as flavor, appearance, texture, and shelf life. The updated and expanded second edition continues to offer an authoritative overview of the subject, while also broadening its scope to include six newly written chapters covering the latest developments in water activity research. Exploring topics ranging from deliquescence to crispness, these insightful new inclusions complement existing content that has been refreshed and reconfigured to support the food industry of today.

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

This 6th edition of the established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.

Microbial Extremozymes: Novel Sources and Industrial Applications is a unique resource of practical research information on the latest novel sources and technologies regarding extremozymes in bioremediation, waste management, valorization of industrial by-products, biotransformation of natural polymers, nutrition, food safety and diagnosis of disease. The book's broad knowledge and varying applications are useful to the food industry, dairy industry, fruit and vegetable processing, and baking and beverages industries, as well as the pharmaceutical and biomedical industries. This is a concise, all-encompassing resource for a range of scientists needing knowledge of extremozymes to enhance and research. Furthermore, it provides an updated knowledge of microbial enzymes isolated from extreme environments (temperatures, etc.) and their biotechnological applications. It will be useful to researchers, scientists and students in enzyme research. In addition, users from the dairy and baking industries will benefit from the presented content. Explores recent scientific research on extremophiles and extremozymes technologies that help innovate novel ideas Provides innovative technologies for enzyme production from extremophilic microbes Includes cutting-edge research for applications in various industries where extreme temperature conditions exist Presents novel microorganisms and their enzymes from extreme environments (Thermophilic, Psychrophilic, Acidophilic, Alkaliphilic, Anaerobic, Halophilic, Barophilic, Metallotolerant, Radioresistant, etc.)