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Accelerated Predictive Stability APS

Accelerated Predictive Stability  APS  Book
Author : Fenghe Qiu,Garry Scrivens
Publisher : Academic Press
Release : 2018-06-28
ISBN : 0128027851
Language : En, Es, Fr & De

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Book Description :

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

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development Book
Author : Kangping Xiao
Publisher : John Wiley & Sons
Release : 2020-10-06
ISBN : 1119547857
Language : En, Es, Fr & De

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Book Description :

This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

Dosage Form Design Considerations

Dosage Form Design Considerations Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-28
ISBN : 0128144246
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Statistical Applications for Chemistry Manufacturing and Controls CMC in the Pharmaceutical Industry

Statistical Applications for Chemistry  Manufacturing and Controls  CMC  in the Pharmaceutical Industry Book
Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Publisher : Springer
Release : 2017-02-14
ISBN : 3319501860
Language : En, Es, Fr & De

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Book Description :

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products Book
Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Release : 2020-03-13
ISBN : 3030314154
Language : En, Es, Fr & De

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Book Description :

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Pharmaceutical Industry Practices on Genotoxic Impurities

Pharmaceutical Industry Practices on Genotoxic Impurities Book
Author : Heewon Lee
Publisher : CRC Press
Release : 2014-08-29
ISBN : 1439874212
Language : En, Es, Fr & De

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Book Description :

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati

Energy Research Abstracts

Energy Research Abstracts Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Energy Research Abstracts book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Nutrient Requirements of Swine

Nutrient Requirements of Swine Book
Author : National Research Council,Division on Earth and Life Studies,Board on Agriculture and Natural Resources,Committee on Nutrient Requirements of Swine
Publisher : National Academies Press
Release : 2012-08-02
ISBN : 0309224233
Language : En, Es, Fr & De

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Book Description :

Since 1944, the National Research Council has published 10 editions of the Nutrient Requirements of Swine. This reference has guided nutritionists and other professionals in academia and the swine and feed industries in developing and implementing nutritional and feeding programs for swine. The swine industry has undergone considerable changes since the tenth edition was published in 1998 and some of the requirements and recommendations set forth at that time are no longer relevant or appropriate. The eleventh revised edition of the Nutrient Requirements of Swine builds on the previous editions published by the National Research Council. A great deal of new research has been published during the last 15 years and there is a large amount of new information for many nutrients. In addition to a thorough and current evaluation of the literature on the energy and nutrient requirements of swine in all stages of life, this volume includes information about feed ingredients from the biofuels industry and other new ingredients, requirements for digestible phosphorus and concentrations of it in feed ingredients, a review of the effects of feed additives and feed processing, and strategies to increase nutrient retention and thus reduce fecal and urinary excretions that could contribute to environmental pollution. The tables of feed ingredient composition are significantly updated. Nutrient Requirements of Swine represents a comprehensive review of the most recent information available on swine nutrition and ingredient composition that will allow efficient, profitable, and environmentally conscious swine production.

Industrial Aspects of Pharmecuticals

Industrial Aspects of Pharmecuticals Book
Author : SANDELL
Publisher : CRC Press
Release : 1992-06-01
ISBN : 9789186274467
Language : En, Es, Fr & De

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Book Description :

Download Industrial Aspects of Pharmecuticals book written by SANDELL, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Combination Vaccines

Combination Vaccines Book
Author : Ronald W. Ellis
Publisher : Springer Science & Business Media
Release : 1999-05-25
ISBN : 1592592651
Language : En, Es, Fr & De

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Book Description :

A diverse team of leading experts comprehensively review the complex biology of a wide variety of vaccine combinations, as well as the technical, clinical, and regulatory aspects of their development. Topics covered range from the use of immunological correlates of efficacy, rather than efficacy per se, for the evaluation and licensure of vaccine combinations, to preserving a stable immunogenic mixture in appropriate containers according to accepted regulatory standards. Discussed in detail are the trivalent influenza vaccine, the pneumococcal polysaccharide vaccine, the MMR vaccine, the DTP vaccine and its combinations, and the quadrivalent rotavirus vaccine, all of which serve as models for the development of future combinations. Combination Vaccines: Development, Clinical Research, and Approval illuminates all the scientific, clinical, regulatory, and health care issues involved in the research, development, and human use of combination vaccines.

Methanol Fuel Modification for Highway Vehicle Use

Methanol Fuel Modification for Highway Vehicle Use Book
Author : J. L. Keller,G. M. Nakaguchi,J. C. Ware
Publisher : Unknown
Release : 1978
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Methanol Fuel Modification for Highway Vehicle Use book written by J. L. Keller,G. M. Nakaguchi,J. C. Ware, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biopharmaceutical Production Technology 2 Volume Set

Biopharmaceutical Production Technology  2 Volume Set Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2012-08-20
ISBN : 3527330291
Language : En, Es, Fr & De

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Book Description :

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

Handbook of Analysis of Edible Animal By Products

Handbook of Analysis of Edible Animal By Products Book
Author : Leo M.L. Nollet,Fidel Toldra
Publisher : CRC Press
Release : 2011-04-01
ISBN : 1439803617
Language : En, Es, Fr & De

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Book Description :

Considered high-priced delicacies or waste material to be tossed away, the use and value of offal-edible and inedible animal by-products-depend entirely on the culture and country in question. The skin, blood, bones, meat trimmings, fatty tissues, horns, hoofs, feet, skull, and entrails of butchered animals comprise a wide variety of products inclu

Fundamentals of Early Clinical Drug Development

Fundamentals of Early Clinical Drug Development Book
Author : Ahmed F. Abdel-Magid,Stéphane Caron
Publisher : John Wiley & Sons
Release : 2006-09-29
ISBN : 0470043393
Language : En, Es, Fr & De

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Book Description :

An informative look at the intricacies of today's drug development process Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield. This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation. Both novice and active researchers will appreciate the inclusion of chapters on such diverse topics as: * Cross-coupling methods * Asymmetric synthesis * Automation * Chemical Engineering * Application of radioisotopes * Final form selection * Formulations * Intellectual property A wealth of real-world examples and contributions from leading process scientists, engineers, and related professionals make this book a valuable addition to the scientific literature.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Book
Author : John Geigert
Publisher : Springer
Release : 2019-05-08
ISBN : 3030137546
Language : En, Es, Fr & De

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Book Description :

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-07-13
ISBN : 0470595876
Language : En, Es, Fr & De

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Book Description :

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.

Poucher s Perfumes Cosmetics and Soaps

Poucher   s Perfumes  Cosmetics and Soaps Book
Author : H. Butler
Publisher : Springer Science & Business Media
Release : 2013-06-29
ISBN : 9401727341
Language : En, Es, Fr & De

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Book Description :

Poucher's Perfumes Cosmetics and Soaps has been in print since 1923 and is the classic reference work in the field of cosmetics. Now in a fully updated 10th edition, this new volume provides a firm basic knowledge in the science of cosmetics (including toiletries) as well as incorporating the latest trends in scientific applications and legislation which have occurred since the 9th edition. This edition will not only be an excellent reference book for students entering the industry but also for those in specialized research companies, universities and other associated institutions who will be able to gain an overall picture of the modern cosmetic science and industry. The book has been logically ordered into four distinct parts. The historical overview of Part 1 contains an essay demonstrating William Arthur Poucher's influence on the 20th Century cosmetics industry as well as a chapter detailing the long history of cosmetics. Part 2 is a comprehensive listing of the properties and uses of common cosmetic types, ranging from Antiperspirants through to Sunscreen preparations. There are an increased number of raw materials in use today and their chemical, physical and safety benefits are carefully discussed along with formulation examples. The many additions since the last edition demonstrate the dramatic recent expansion in the industry and how changes in legal regulations affecting the development, production and marketing of old, established and new products are operative almost worldwide. Information on specialist products for babies and others is included within individual chapters. The chapters in Part 3 support and outline the current guidelines regarding the assessment and control of safety and stability. This information is presented chemically, physically and microbiologically. Part 3 chapters also detail requirements for the consumer acceptability of both existing and new products. Those legal regulations now in force in the EU, the USA and Japan are carefully described in a separate chapter and the remaining chapters have been extensively updated to explain the technical and practical operations needed to comply with regulations when marketing. This information will be invaluable to European Union and North American companies when preparing legally required product information dossiers. The final chapters in Part 4 contain useful information on the psychology of perfumery as well as detailing methods for the conduct of assessment trials of new products. As ingredient labelling is now an almost universal legal requirement the International Nomenclature of Cosmetics Ingredients (INCI) for raw materials has been used wherever practicable. The advertised volume is the 10th edition of what was previously known as volume 3 of Poucher's Cosmetics and Soaps. Due to changes in the industry there are no plans to bring out new editions of volume 1 and 2.

Bulletin

Bulletin Book
Author : Anonim
Publisher : Unknown
Release : 2021-12-08
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Bulletin book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Supplement to the Bibliography and Abstracts on Thermostat Metals

Supplement to the Bibliography and Abstracts on Thermostat Metals Book
Author : Anonim
Publisher : ASTM International
Release : 1974
ISBN : 9780803107656
Language : En, Es, Fr & De

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Book Description :

Download Supplement to the Bibliography and Abstracts on Thermostat Metals book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Delivery Systems Third Edition

Drug Delivery Systems  Third Edition Book
Author : Vasant V. Ranade,John B. Cannon
Publisher : CRC Press
Release : 2011-04-25
ISBN : 1439806187
Language : En, Es, Fr & De

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Book Description :

Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.