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This is an introductory statistics book designed to provide scientists with practical information needed to apply the most common statistical tests to laboratory research data. The book is designed to be practical and applicable, so only minimal information is devoted to theory or equations. Emphasis is placed on the underlying principles for effective data analysis and survey the statistical tests. It is of special value for scientists who have access to Minitab software. Examples are provides for all the statistical tests and explanation of the interpretation of these results presented with Minitab (similar to results for any common software package). Practical Statistics for Pharmaceutical Analysis is specifically designed to contribute to the AAPS series on advances in the pharmaceutical sciences. It benefits professional scientists or graduate students who have not had a formal statistics class, who had bad experiences in such classes, or who just fear/don’t understand statistics.

Pharmaceutical technology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Pharmacy. --- Pharmaceutical Sciences/Technology. --- Chemistry --- Medicine --- Drugs --- Materia medica --- Pharmacology --- Tecnologia farmacèutica --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia

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The book focuses on protein allostery in drug discovery. Allosteric regulation, ʹthe second secret of lifeʹ, fine-tunes virtually most biological processes and controls physiological activities. Allostery can both cause human diseases and contribute to development of new therapeutics. Allosteric drugs exhibit unparalleled advantages compared to conventional orthosteric drugs, rendering the development of allosteric modulators as an appealing strategy to improve selectivity and pharmacodynamic properties in drug leads. The Series delineates the immense significance of protein allostery—as demonstrated by recent advances in the repertoires of the concept, its mechanistic mechanisms, and networks, characteristics of allosteric proteins, modulators, and sites, development of computational and experimental methods to predict allosteric sites, small-molecule allosteric modulators of protein kinases and G-protein coupled receptors, engineering allostery, and the underlying role of allostery in precise medicine. Comprehensive understanding of protein allostery is expected to guide the rational design of allosteric drugs for the treatment of human diseases. The book would be useful for scientists and students in the field of protein science and Pharmacology etc. .

Pharmaceutical technology. --- Proteins . --- Biomedical engineering. --- Pharmaceutical Sciences/Technology. --- Protein Science. --- Protein Structure. --- Biomedical Engineering/Biotechnology. --- Clinical engineering --- Medical engineering --- Bioengineering --- Biophysics --- Engineering --- Medicine --- Proteids --- Biomolecules --- Polypeptides --- Proteomics --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Allosteric proteins. --- Proteins --- Proteins, Allosteric --- Cooperative binding (Biochemistry) --- Protein binding --- Allosterism --- Tecnologia farmacèutica --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia

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This book closes a current gap by providing the scientific basis for consumer exposure assessment in the context of regulatory risk assessment. Risk is defined as the likelihood of an event occurring and the severity of its effects. The margin between the dose that leads to toxic effects and the actual dose of a chemical is identified by estimating population exposure. The objective of this book is to provide an introduction into the scientific principles of consumer exposure assessment, and to describe the methods used to estimate doses of chemicals, the statistics applied and computer tools needed. This is presented through the backgrounds of the special fields in exposure analysis, such as exposure via food and by the use of consumer products, toys, clothing and other items. As a general concept, human exposure is also understood to include exposure via the environment and from the work setting. In this context, the specific features of consumer exposure are pointed out and put into the context of regulation, in particular food safety, chemicals safety (REACh) and consumer product safety. The book is structured into three parts: The first part deals with the general concepts of consumer exposure as part of the overall risk analysis framework of risk characterization, risk assessment and risk communication. It describes the three basic features of exposure assessment (i) the exposure scenario (ii) the exposure model and (iii) the exposure parameters, addressing external and internal exposure. Also, the statistical presentation of data to characterize populations, in connection with variability, uncertainty and quality of information and the presentation of exposure evaluation results is described. The second part deals with the specific issues of exposure assessment, exposure via food consumption, exposure from use of consumer products, household products, toys, cosmetic products, textiles, pesticides and others. This part also covers methods for acquisition of data for exposure estimations, including the relevant information from regulations needed to perform an accurate exposure assessment. The third part portrays a prospect for further needs in the development and improvement of consumer exposure assessment, as well as international activities and descriptions of the work of institutions that are involved in exposure assessment on the regulatory and scientific level. And conversely, it creates the rationale for the exposure assessment details necessary to satisfy regulatory needs such as derivation of upper limits and risk management issues.

Pharmaceutical technology. --- Occupational medicine. --- Chemistry. --- Pharmaceutical Sciences/Technology. --- Occupational Medicine/Industrial Medicine. --- Safety in Chemistry, Dangerous Goods. --- Industrial medicine --- Medicine, Occupational --- Occupational medicine --- Medicine --- Occupational diseases --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Physical sciences --- Tecnologia farmacèutica --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia

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This book provides practical guidance on all aspects of reverse phase protein array (RPPA) technology, which permits the quantification of protein levels in cell or tissue lysates. In addition, the latest results are presented from laboratories across the world where experts are successfully running the challenging RPPA data platform. After an introductory chapter by the inventor of the RPPA technique, the demanding task of lysate preparation is explained. Subsequent chapters review printing platforms and analytical platforms and discuss antibody screening in detail. The role of RPPA data in integrative analyses is thoroughly examined, and the various applications of RPPA, for example to identify molecular targeting drugs or evaluate cancer drug efficacy, are discussed with reference to the latest knowledge. It is hoped that the book will foster the implementation of RPPA by documenting the practical details of the technology and by revealing its great potential. It will be of high value for researchers who plan to build an RPPA platform in their institute and for researchers, clinicians, and companies who use RPPA through collaboration with an existing RPPA facility.

Proteins. --- Proteids --- Biomolecules --- Polypeptides --- Proteomics --- Molecular biology. --- Cancer research. --- Proteins . --- Biomedical engineering. --- Microarrays. --- Pharmaceutical technology. --- Molecular Medicine. --- Cancer Research. --- Protein Science. --- Biomedical Engineering/Biotechnology. --- Pharmaceutical Sciences/Technology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Clinical engineering --- Medical engineering --- Bioengineering --- Biophysics --- Engineering --- Medicine --- Cancer research --- Molecular biochemistry --- Molecular biophysics --- Biochemistry --- Systems biology --- Enginyeria de proteïnes --- Tecnologia farmacèutica --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia --- Disseny de proteïnes --- Tecnologia de proteïnes --- Enginyeria bioquímica --- Enginyeria genètica

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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 technology. --- Pharmacy. --- Pharmaceutical Sciences/Technology. --- Drug delivery systems. --- Drug development. --- Chemistry --- Medicine --- Drugs --- Materia medica --- Pharmacology --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Development of drugs --- New drug development --- Pharmacy --- Delivery systems, Drug --- Drug administration technology --- Drug delivery technology --- Pharmaceutical technology --- Development --- Delivery systems --- Biofarmàcia --- Tecnologia farmacèutica --- Immunoglobulines --- Anticossos --- Proteïnes de la sang --- Autoanticossos --- Anticossos monoclonals --- Anticossos policlonals --- Antihormones --- Antitoxines --- Immunofluorescència --- Immunoglobulina A --- Immunoglobulina E --- Immunoglobulina G --- Immunoglobulina M --- Lectines --- Antígens --- Gammaglobulines --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia --- Biofarmacèutica --- Biofarmacologia --- Farmacologia --- Equivalència terapèutica dels medicaments