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New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics
ISBN: 9780824754655 / Angielski / Twarda / 500 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This reference helps those new to the world of pharmaceutical development reduce costs, save time, and attain straightforward guidance through each step of the drug approval process - acquainting readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected officials from agencies around the globe.
This reference helps those new to the world of pharmaceutical development reduce costs, save time, and attain straightforward guidance through each st...
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Pharmaceutical Engineering Change Control
ISBN: 9780849320613 / Angielski / Twarda / 200 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control...
Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It cov...
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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
ISBN: 9780849327063 / Angielski / Twarda / 452 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Enhancing awareness to increase the development of excipients, this source: * provides guidelines for testing new exipients * offers information to ensure that the product ingredients are in compilance with regulatory and quality requirements, and to guarantee the manufacturing and supply chain is in control *includes excipient harmonization activities *features descriptions on the development and ways of opitmal utilization of excipients for the pharmaceutical and biotechnology industries * presents multilpe case studies for numerous functional excipients Audience To facilitate the...
Enhancing awareness to increase the development of excipients, this source: * provides guidelines for testing new exipients * offers information to en...
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Pharmaceutical Isothermal Calorimetry
ISBN: 9780849331558 / Angielski / Twarda / 363 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems. Providing a comprehensive review of recent research and trends, this book contains an expert discussion of research and applications to pharmaceutical characterization and formulation.
Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational de...
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Protein Formulation and Delivery
ISBN: 9780849379499 / Angielski / Twarda / 376 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also...
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product de...
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Pharmaceutical and Medical Device Validation by Experimental Design
ISBN: 9781420055696 / Angielski / Twarda / 272 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a ...
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Modern Pharmaceutics Volume 1: Basic Principles and Systems, Fifth Edition
ISBN: 9781420065640 / Angielski / Twarda / 656 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. With over 100 illustrations, "Volume 1" addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics.
Key topics in "Volume 1" include: With over 100 illustrations, "Volume 1" addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packagin...
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Modern Pharmaceutics, Volume 2: Applications and Advances, Fifth Edition
ISBN: 9781420065664 / Angielski / Twarda / 560 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. "Volume 2" addresses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In addition, this text discusses the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology.
"Volume 2" investigates: "Volume 2" addresses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In additi...
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Genomics: Fundamentals and Applications
ISBN: 9781420067057 / Angielski / Twarda / 432 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This unique new text delivers a solid foundation for understanding the role of genomics in human health and in advances that promise to help improve the quality of human life. Unlike other works that focus mainly on toxicogenomic techniques, Genomics presents a thorough overview of the field in four major sections: 1) fundamentals of genes and genome structure, function, expression, variations, and genomic technology platforms; 2) applications of genomics in drug discovery and drug development, safety evaluation, genomic database maintenance, mining, and analysis,... This unique new text delivers a solid foundation for understanding the role of genomics in human health and in advances that promise to help improv... |
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Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition
ISBN: 9781420067521 / Angielski / Twarda / 496 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well...
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Functional Informatics in Drug Discovery
ISBN: 9781574444667 / Angielski / Twarda / 160 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Integrating various technologies with informational systems provides vast improvements to the overall research and development that occur in the biopharmaceutical industry. One of the first books to explore this area, Functional Informatics in Drug Discovery examines all aspects of technology integration and information flow in a biopharmaceutical enterprise and outlines the specific technologies used at various stages of drug development.
With contributions from leaders in academia, information technology, and the pharmaceutical industry, each chapter illustrates how a particular area of... Integrating various technologies with informational systems provides vast improvements to the overall research and development that occur in the bioph...
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Drug Synergism and Dose-Effect Data Analysis
ISBN: 9781584880455 / Angielski / Twarda / 264 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Not since this author's bestselling Manual of Pharmacologic Calculatio n - long out of print - has there been an available reference for drug data analysis. Incorporating the most relevant parts of that work, Dr ug Synergism and Dose-Effect Data Analysis focuses on drug combination s and all the quantitative analysis needed to analyze combination drug data and to design experiments with two or more compounds. Much of th e book is statistical, providing the theory and the computation algori thms needed to analyze single and combination drug data.
Not since this author's bestselling Manual of Pharmacologic Calculatio n - long out of print - has there been an available reference for drug data ana...
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Drug Metabolism: Chemical and Enzymatic Aspects
ISBN: 9780849375958 / Angielski / Twarda / 179 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. In order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structure and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market. This title is a comprehensive guide for recognizing the chemical underpinnings of drug metabolism. While there are numerous resources available to medicinal chemists for understanding drug structure, and to pharmacologists for discerning drug metabolism from a biological standpoint, no resource currently exists...
In order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structure and pr...
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Drug Delivery Nanoparticles Formulation and Characterization
ISBN: 9781420078046 / Angielski / Twarda / 416 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Explore the fundamental concepts of drug delivery formulation and characterization. Nanoparticulate Drug Delivery Systems II presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval. This comprehensive guide features:
Explore the fundamental concepts of drug delivery formulation and characterization. Nanoparticulate Drug Delivery Systems II presents key aspect... |
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Proteins and Peptides: Pharmacokinetic, Pharmacodynamic, and Metabolic Outcomes
ISBN: 9781420078060 / Angielski / Twarda / 288 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is an invaluable source for drug discovery and development scientists in the biopharmaceutical industry who frequently navigate the maze of protein and peptide pharmacokinetics, pharmacodynamics, and metabolism.
Key features include:
Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive s...
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Pharmaceutical Product Branding Strategies: Simulating Patient Flow and Portfolio Dynamics
ISBN: 9781420087703 / Angielski / Twarda / 312 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This updated Second Edition details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes. By introducing the reader to the complexities facing many pharmaceutical firms, specifically issues around cross-functional coordination and knowledge integration, this guide provides a framework for dynamic modeling of interest to several pharmaceutical markets, including epidemiology, market definitions, compliance/persistency, and revenue...
This updated Second Edition details how marketers, forecasters, and brand planners can achieve optimal success by building internally co...
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Shengmai San
ISBN: 9780415284905 / Angielski / Twarda / 160 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Traditional Chinese medicine commonly prescribes herbal formulas for the prevention and treatment of diseases. Shengmai San, a famous Chinese medicinal formula that has been used for more than eight hundred years in China, is comprised of Radix Ginseng, Fructus Schisandre and Radix Ophiopogonis. Traditionally, Shengmai San is used for the treatment of excessive loss of essence Qi and body fluid that threaten heart failure, particularly in the summer when heat exhaustion and profuse sweating commonly occur.
This book provides a comprehensive treatise on the historical, phytochemical,... Traditional Chinese medicine commonly prescribes herbal formulas for the prevention and treatment of diseases. Shengmai San, a famous Chinese medicina...
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Quantitative Drug Design: A Critical Introduction
ISBN: 9781420070996 / Angielski / Twarda / 292 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Since the publication of the first edition, the field has changed dramatically. Scientists can now explicitly consider 3D features in quantitative structure-activity relationship (QSAR) studies and often have the 3D structure of the macromolecular target to guide the 3D QSAR. Improvements in computer hardware and software have also made the methods more accessible to scientists. Taking these developments into account, Quantitative Drug Design: A Critical Introduction, Second Edition shows scientists how to apply QSAR techniques at a state-of-the-art... Since the publication of the first edition, the field has changed dramatically. Scientists can now explicitly consider 3D features in quantitative ... |
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Generic Drug Product Development: Specialty Dosage Forms
ISBN: 9780849377860 / Angielski / Twarda / 288 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal... Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equiv... |
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Topical Antimicrobials Testing and Evaluation
ISBN: 9781439813225 / Angielski / Twarda / 200 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial... A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preope... |
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