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
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
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.
The rapid increase of web pages has introduced new challenges for many organizations as they attempt to extract information from a massive corpus of web pages. Finding relevant information, eliminating irregular content, and retrieving accurate results has become extremely difficult in today’s world where there is a surplus of information available. It is crucial to further understand and study web mining in order to discover the best ways to connect users with appropriate information in a timely manner. Advanced Practical Approaches to Web Mining Techniques and Application aims to illustrate all the concepts of web mining and fosters transformative, multidisciplinary, and novel approaches that introduce the practical method of analyzing various web data sources and extracting knowledge by taking into consideration the unique challenges present in the environment. Covering a range of topics such as data science and security threats, this reference work is ideal for industry professionals, researchers, academicians, practitioners, scholars, instructors, and students.
This book provides information on interdependencies of medicine and telecommunications engineering and how the two must rely on each other to effectively function in this era. The book discusses new techniques for medical service improvisation such as clear-cut views on medical technologies. The authors provide chapters on communication essentiality in healthcare, processing of medical amenities using medical images, the importance of data and information technology in medicine, and machine learning and artificial intelligence in healthcare. Authors include researchers, academics, and professionals in the field.
This book is the eighth volume in the series Acute Exposure Guideline Levels for Selected Airborne Chemicals, and reviews AEGLs for acrolein, carbon monoxide, 1,2-dichloroethene, ethylenimine, fluorine, hydrazine, peracetic acid, propylenimine, and sulfur dioxide for scientific accuracy, completeness, and consistency with the NRC guideline reports.
Since its creation in 1963, United States Southern Command has been led by 30 senior officers representing all four of the armed forces. None has undertaken his leadership responsibilities with the cultural sensitivity and creativity demonstrated by Admiral Jim Stavridis during his tenure in command. Breaking with tradition, Admiral Stavridis discarded the customary military model as he organized the Southern Command Headquarters. In its place he created an organization designed not to subdue adversaries, but instead to build durable and enduring partnerships with friends. His observation that it is the business of Southern Command to launch "ideas not missiles" into the command's area of responsibility gained strategic resonance throughout the Caribbean and Central and South America, and at the highest levels in Washington, DC.
Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors' many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of
This book contains the summaries of the "Innovation in Pharmacy: Advances and Perspectives" that took place in Salamanca (Spain) in September 2018. The early science of chemistry and microbiology were the source of most drugs until the revolution of genetic engineering in the mid 1970s. Then biotechnology made available novel protein agents such as interferons, blood factors and monoclonal antibodies that have changed the modern pharmacy. Over the past year, a new pharmacy of oligonucleotides has emerged from the science of gene expression such as RNA splicing and RNA interference. The ability to design therapeutic agents from genomic sequences will transform treatment for many diseases. The science that created this advance and its future promise will be discussed. Phillip Allen Sharp is an American geneticist and molecular biologist who co-discovered RNA splicing. He shared the 1993 Nobel Prize in Physiology or Medicine with Richard J. Roberts for “the discovery that genes in eukaryotes are not contiguous strings but contain introns, and that the splicing of messenger RNA to delete those introns can occur in different ways, yielding different proteins from the same DNA sequence. He works in Institute Professor Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology (MIT), Cambridge, MA, US. Este libro recoge los resúmenes de la «Innovation in Pharmacy: Advances and Perspectives» que tuvo lugar en Salamanca (España) en septiembre de 2018. La ciencia primitiva de la química y la microbiología fue la fuente de la mayoría de las drogas hasta la revolución de la ingeniería genética a mediados de la década de 1970. Luego, la biotecnología puso a disposición agentes proteínicos novedosos como interferones, factores sanguíneos y anticuerpos monoclonales que han cambiado la farmacia moderna. Durante el año pasado, surgió una nueva farmacia de oligonucleótidos a partir de la ciencia de la expresión génica, como el empalme de ARN y la interferencia de ARN. La capacidad de diseñar agentes terapéuticos a partir de secuencias genómicas transformará el tratamiento de muchas enfermedades. La ciencia que creó este avance y su promesa futura será discutida. Phillip Allen Sharp es un genetista y biólogo molecular estadounidense que co-descubrió el empalme de ARN. Compartió el Premio Nobel de 1993 en Fisiología o Medicina con Richard J. Roberts por "el descubrimiento de que los genes en eucariotas no son cadenas contiguas, sino que contienen intrones, y que el empalme del ARN mensajero para eliminar esos intrones puede ocurrir de diferentes maneras, produciendo diferentes proteínas de la misma secuencia de ADN. Trabaja en el Instituto Profesor Koch Institute for Integrative Cancer Research, Instituto Tecnológico de Massachusetts (MIT), Cambridge, MA, EE. UU.
Characterization of Nanoencapsulated Food Ingredients, Volume Four in the Nanoencapsulation in the Food Industry series, introduces some of the common instrumental analysis and characterization methods for the evaluation of nanocarriers and nanoencapsulated ingredients in terms of their morphology, size distribution, surface charge and composition, appearance, physicochemical and rheological properties, and antioxidant activity. Divided in five sections, the book covers the qualitative and quantitative properties of nanoencapsulated food ingredients by different characterization techniques, besides correlating nanocarrier behavior to their physicochemical and functional properties. Authored by a team of global experts in the fields of nano- and microencapsulation of food, nutraceutical, and pharmaceutical ingredients, this title is of great value to those engaged in the various fields of nanoencapsulation and nanodelivery systems. - Shows how different properties of nanoencapsulated food ingredients can be analyzed - Presents the mechanism of each characterization technique - Investigates how the analytical results can be understood with nanoencapsulated ingredients
