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The Pharmaceutical Regulatory Process
ISBN: 9781420070422 / Angielski / Twarda / 650 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover:
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focu... |
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930,57 |
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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
ISBN: 9781420073546 / Angielski / Twarda / 464 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The "Second Edition" focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
"FDA Regulatory... Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device developmen...
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930,57 |
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Pharmacokinetics in Drug Discovery and Development
ISBN: 9781566769730 / Angielski / Twarda / 440 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Detailed descriptions of the pertinent subspecialties of pharmacokinetics Chapters written by experts provide extensive background into each subspecialty Useful pharmacokinetic applications to industrial, regulatory, clinical, and research disciplines Comprehensive coverage of pharmacokinetic concepts including terminology and approaches Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a...
Detailed descriptions of the pertinent subspecialties of pharmacokinetics Chapters written by experts provide extensive background into each subspecia...
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930,57 |
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Nanoparticle Technology for Drug Delivery
ISBN: 9781574448573 / Angielski / Twarda / 428 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioavailability, allow tissue targeting, offer decreased side-effects, and improve therapeutic efficacy. Presenting the most pertinent and practical issues in the manufacturing and biological application of nanoparticles, this source presents state-of-the-art scientific contributions by seasoned authorities in the field.
Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioa...
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930,57 |
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Spectroscopy of Pharmaceutical Solids
ISBN: 9781574448931 / Angielski / Twarda / 580 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may facilitate more advanced technologies in the field.
Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectrosco...
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930,57 |
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Estrogen and the Vessel Wall
ISBN: 9789057022838 / Angielski / Twarda / 288 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Estrogen and the Vessel Wall marks the start of a new era in understanding the cardiovascular actions of estrogen. It examines the hypothesis, derived from a growing body of epidemiological data, that estrogen acts directly upon the vessel wall to produce beneficial effects in the cardiovascular system.
Inspired by a satellite symposium of the IX International Vascular Biology Meeting, additional topics have been included, covered by leading experts. All subjects have been brought together here to produce an outstanding and integral publication, a milestone in the field of Vascular... Estrogen and the Vessel Wall marks the start of a new era in understanding the cardiovascular actions of estrogen. It examines the hypothesis, derived...
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930,57 |
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Sustained-Release Injectable Products
ISBN: 9781574911015 / Angielski / Twarda / 552 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.
Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administrati...
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930,57 |
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Muscarinic Receptor Subtypes in Smooth Muscle
ISBN: 9780849385490 / Angielski / Twarda / 192 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This book explores several subtypes of muscarinic receptors that modulate smooth muscle activity. Main topics include a classification of muscarinic receptors, biochemical responses that occur in smooth muscle, the role of muscarinic receptors in the function of gastrointestinal and genitourinary smooth muscle, and prejunctional muscarinic receptors in smooth muscle. Discussions explore the current state of research and are intended to generate further research into the design of novel therapeutics for disorders of smooth muscle function.
This book explores several subtypes of muscarinic receptors that modulate smooth muscle activity. Main topics include a classification of muscarinic r...
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930,57 |
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Pharmaceutical Dosage Forms - Tablets: Manufacture and Process Control
ISBN: 9780849390166 / Angielski / Twarda / 328 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form. With over 700 illustrations, it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the Third Edition: ...The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates ... |
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930,57 |
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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
ISBN: 9781574911176 / Angielski / Twarda / 544 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical info...
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930,57 |
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Dietary Supplement Good Manufacturing Practices: Preparing for Compliance
ISBN: 9781420077407 / Angielski / Twarda / 298 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. "Dietary Supplement GMP "is a one-stop 'how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA that cover the manufacturing, packaging, and holding of dietary supplement products.
The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances, which leaves implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP... "Dietary Supplement GMP "is a one-stop 'how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA that cover the man...
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930,57 |
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New Drug Approval Process
ISBN: 9781420088496 / Angielski / Twarda / 552 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include:
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical produc... |
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930,57 |
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Pharmaceutical Water: System Design, Operation, and Validation, Second Edition
ISBN: 9781420077827 / Angielski / Twarda / 478 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries-used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. Drawing on the author's extensive field experience with more than 400 pharmaceutical and related water purification systems, the text's numerous case studies illuminate the best and worst of water system design and operation. The expanded Second Edition also includes new chapters that... A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries-used as an excip... |
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930,57 |
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Pharmaceutical Powder Compaction Technology
ISBN: 9781420089172 / Angielski / Twarda / 344 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. Compaction of powder constituents -- both active ingredient and excipients -- is examined to ensure consistent and reproducible disintegration and dispersion profiles. This unique reference covers: * the physical structure of pharmaceutical compacts * bonding phenomena that occur during powder compaction * compression mechanisms of...
Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and produ...
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930,57 |
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Magnolia: The Genus Magnolia
ISBN: 9780415284943 / Angielski / Twarda / 200 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. The genus Magnolia consists of several medicinally important species most of which come from Far East Asia. Many species of this genus have traditionally been used in China and Japan to treat various illnesses from simple headaches to complicated cancer, and because of their versatility have more recently been incorporated into commercially successful medicine preparations. And with the revival of interest in herbal and oriental traditional medicines, many of these Magnolia-containing preparations have captured a significant proportion of the drug market in the Western countries. In recent...
The genus Magnolia consists of several medicinally important species most of which come from Far East Asia. Many species of this genus have traditiona...
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930,57 |
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Automation and Validation of Information in Pharmaceutical Processing
ISBN: 9780824701192 / Angielski / Twarda / 464 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.
Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for... This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutica...
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930,57 |
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Profiles of Drug Substances, Excipients and Related Methodology: Volume 34
ISBN: 9780123743404 / Angielski / Twarda / 350 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug...
Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that su...
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930,57 |
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Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition
ISBN: 9781420092387 / Angielski / Twarda / 332 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. Updated to reflect modern advances in the techniques and methodology of drug stereochemistry, the Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This stand-alone text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.
New topics in the Third Edition include: The use of enzymes in the synthesis and resolution of... Updated to reflect modern advances in the techniques and methodology of drug stereochemistry, the Third Edition comprehensively presents all aspects o...
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930,57 |
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Pharmaceutical Dosage Forms - Parenteral Medications: Volume 2: Facility Design, Sterilization and Processing
ISBN: 9781420086454 / Angielski / Twarda / 418 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it...
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and ...
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930,57 |
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Pharmaceutical Dosage Forms: Capsules
ISBN: 9781841849768 / Angielski / Twarda / 421 str. Termin realizacji zamówienia: ok. 5-8 dni roboczych. |
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930,57 |
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