Strategies For Formulations Development
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| Author | : Feroz Jameel |
| Publisher | : John Wiley & Sons |
| Total Pages | : 986 |
| Release | : 2010-07-13 |
| Genre | : Science |
| ISBN | : 0470595876 |
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
| Author | : Ronald Snee |
| Publisher | : SAS Institute |
| Total Pages | : 294 |
| Release | : 2016-09-14 |
| Genre | : Computers |
| ISBN | : 1629605328 |
This book is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process.
| Author | : Jack Zheng |
| Publisher | : John Wiley & Sons |
| Total Pages | : 506 |
| Release | : 2009-02-09 |
| Genre | : Medical |
| ISBN | : 0470056096 |
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
| Author | : Yogeshwar Bachhav |
| Publisher | : John Wiley & Sons |
| Total Pages | : 470 |
| Release | : 2019-12-04 |
| Genre | : Science |
| ISBN | : 3527343962 |
Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
| Author | : Elizabeth Kwong |
| Publisher | : John Wiley & Sons |
| Total Pages | : 268 |
| Release | : 2017-01-03 |
| Genre | : Medical |
| ISBN | : 1118907906 |
Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
| Author | : Wei Wang |
| Publisher | : John Wiley & Sons |
| Total Pages | : 531 |
| Release | : 2013-08-29 |
| Genre | : Medical |
| ISBN | : 1118695224 |
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
| Author | : Shivani Pathania |
| Publisher | : John Wiley & Sons |
| Total Pages | : 340 |
| Release | : 2021-03-15 |
| Genre | : Technology & Engineering |
| ISBN | : 1119614740 |
Reviews innovative processing techniques and recent developments in food formulation, identification, and utilization of functional ingredients Food Formulation: Novel Ingredients and Processing Techniques is a comprehensive and up-to-date account of novel food ingredients and new processing techniques used in advanced commercial food formulations. This unique volume will help students and industry professionals alike in understanding the current trends, emerging technologies, and their impact on the food formulation techniques. Contributions from leading academic and industrial experts provide readers with informed and relevant insights on using the latest technologies and production processes for new product development and reformulations. The text first describes the basis of a food formulation, including smart protein and starch ingredients, healthy ingredients such as salt and sugar replacers, and interactions within the food components. Emphasizing operational principles, the book reviews state-of-the-art 3D printing technology, encapsulation and a range of emerging technologies including high pressure, pulsed electric field, ultrasound and supercritical fluid extraction. The final chapters discuss recent developments and trends in food formulation, from foods that target allergies and intolerance, to prebiotic and probiotic food formulation designed to improve gut health. A much-needed reference on novel sourcing of food ingredients, processing technologies, and application, this book: Explores new food ingredients as well as impact of processing on ingredient interactions Describes new techniques that improve the flavor and acceptability of functional food ingredients Reviews mathematical tools used for recipe formulation, process control and consumer studies Includes regulations and legislations around tailor-made food products Food Formulation: Novel Ingredients and Processing Techniques is an invaluable resource for students, educators, researchers, food technologists, and professionals, engineers and scientists across the food industry.
| Author | : Ronald Snee |
| Publisher | : |
| Total Pages | : 294 |
| Release | : 2019-08-30 |
| Genre | : Computers |
| ISBN | : 9781642955767 |
Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.
| Author | : John F. Carpenter |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 218 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461505577 |
Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.
| Author | : Vandana B. Patravale |
| Publisher | : CRC Press |
| Total Pages | : 438 |
| Release | : 2016-05-25 |
| Genre | : Medical |
| ISBN | : 1498730787 |
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive
