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Cell Therapy: cGMP Facilities and Manufacturing​

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Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.​

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Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…​

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Standard operating procedures​

Supply management​

Facility equipment​

Product manufacturing, review, release and administration​

Facility master file​

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[ابو ابراهيم]

Handbook of Pharmaceutical Excipients, 6th Edition

"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.​

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Filtration in the Biopharmaceutical Industry

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This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!​

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Pharmaceutical Dosage Forms: Parenteral Medication (Volume 3)

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Product Details​

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• Hardcover: 572 pages
• Publisher: Marcel Dekker; 2 edition (January 15, 1993)
• Language: English
• ISBN-10: 0824790200
• ISBN-13: 978-0824790202
• Product Dimensions: 10 x 7.2 x 1.3 inches
• Shipping Weight: 2.3 pounds (View shipping rates and policies)
• Average Customer Review: No customer reviews yet. Be the first.
• Amazon.com Sales Rank: #2,458,339 in Books

Review​

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. . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production.​

---Pharmaceutical Technology​

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Product Description​

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University of Tennessee, Memphis. Third and final volume of the second edition of an in-depth text on parenteral medications, for graduate and undergraduate students, and industrial or hospital pharmacists. 17 U.S. contributors. DNLM: Infusions, Parenteral​

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Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products (Volume 3 of 6

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Product Details​

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• Hardcover: 320 pages
• Publisher: Informa HealthCare; 1 edition (April 26, 2004)
• Language: English
• ISBN-10: 0849317487
• ISBN-13: 978-0849317484
• Product Dimensions: 11.4 x 8.4 x 0.8 inches
• Shipping Weight: 2 pounds
• Average Customer Review: No customer reviews yet. Be the first.
• Amazon.com Sales Rank: #2,179,384 in Books

Product Description​

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The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs​

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[ابو ابراهيم]

Pharmaceutical Experimental Design And Interpretation

Product Details

• Hardcover: 274 pages
• Publisher: CRC; 1 edition (December 20, 1996)
• Language: English
• ISBN-10: 0748404368
• ISBN-13: 978-0748404360
• Product Dimensions: 10.1 x 6.7 x 0.7 inches
• Shipping Weight: 1.5 pounds

Product Description

This complete revision of Understanding Experimental Design and Interpretation in Pharmaceutics provides a comprehensive and up-to-date guide for anyone involved in planning pharmaceutical experiments and analysing the results.After a brief discussion of the underlying statistical techniques, the major methods of experimental design and evaluation, such as multivariate analysis, principal components analysis and sequential analysis, are examined. A comprehensive review of factorial design, covering classical, partial and block designs, leads to a description of methods of optimization, including model-independent and model-dependent methods such as response surface methodology and multicriteria decision making. A separate chapter applies these methods to mixture designs which are particularly relevant to pharmaceutical formulations. Each chapter draws on real examples from the pharmaceutical industry making the book a practical aid for all pharmaceutical researchers.

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[ابو ابراهيم]

FASTtrack: Pharmaceutics - Dosage Form and Design

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Product details​

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• Paperback: 214 pages
• Publisher: Pharmaceutical Press; 1 edition (19 Oct 2007)
• Language English
• ISBN-10: 0853697000
• ISBN-13: 978-0853697008
• Product Dimensions: 23 x 15.4 x 1.4 cm
• Average Customer Review: No customer reviews yet

Product Description​

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Product Description​

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This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.​

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[ابو ابراهيم]

Protein Formulation and Delivery

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Product Details​

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• Hardcover: 278 pages
• Publisher: Informa HealthCare; 1 edition (September 21, 1999)
• Language: English
• ISBN-10: 0824778839
• ISBN-13: 978-0824778835
• Product Dimensions: 9.1 x 5.9 x 0.8 inches
• Shipping Weight: 15.2 ounces

Review​

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"…a ‘must read’….exceptionally well written….Highly recommended." -- Journal of Controlled Release​

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"…concise and informative... "…the authors have wisely chosen to illustrate their information with real-life examples and case studies." -- Pharmaceutical Development and Technology​

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...written to assist the pharmaceutical scientist involved in the protein formulation and delivery processes...also...of use to students doing thesis research in these areas. Of particular value...are numerous insights into critical practical issues that impact the development of protein therapeutic products.​

- Pharmaceutical Research​

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…a 'must read'….exceptionally well written….Highly recommended.​

-Journal of Controlled Release​

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…concerns very timely topics….​

…well written and organized.​

-Pharmaceutical Research​

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…concise and informative...​

…the authors have wisely chosen to illustrate their information with real-life examples and case studies.​

-Pharmaceutical Development and Technology​

…the most pertinent and readable summary of the familial ataxias that has been written to date.​

…an excellent summary of all the knowledge an interested clinician in this area needs to know.​

-European Journal of Paediatric Neurology​

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…a must read….exceptionally well written….Highly recommended.​

-Journal of Controlled Release​

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…concerns very timely topics….​

…well written and organized.​

-Pharmaceutical Research​

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…concise and informative...​

…the authors have wisely chosen to illustrate their information with real-life examples and case studies.​

-Pharmaceutical Development and Technology​

…the most pertinent and readable summary of the familial ataxias that has been written to date.​

…an excellent summary of all the knowledge an interested clinician in this area needs to know.​

-European Journal of Paediatric Neurology​

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Product Description​

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Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. Directs scientists new to the field of protein formulation to appropriate starting points for development processes. Emphasizes the selection of conditions, excipients, and container closure systems.​

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[ابو ابراهيم]

Impurities Evaluation of Pharmaceuticals

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Product Details​

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• Hardcover: 304 pages
• Publisher: Informa Healthcare; 1 edition (February 1, 1998)
• Language: English
• ISBN-10: 0824798848
• ISBN-13: 978-0824798840
• Product Dimensions: 9.1 x 6.5 x 0.8 inches
• Shipping Weight: 1.3 pounds

Product Description​

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Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.​

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[ابو ابراهيم]

Drug Products for Clinical Trials

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Product Details​

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• Hardcover: 387 pages
• Publisher: Informa HealthCare; 1st edition (January 15, 1998)
• Language: English
• ISBN-10: 082479852X
• ISBN-13: 978-0824798529
• Product Dimensions: 9.2 x 5.7 x 1 inches

Product Description​

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This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!​

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[ابو ابراهيم]

Development of Biopharmaceutical Parenteral Dosage Forms

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Product Details​

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• Hardcover: 264 pages
• Publisher: Informa Healthcare; 1 edition (July 25, 1997)
• Language: English
• ISBN-10: 082479981X
• ISBN-13: 978-0824799816
• Product Dimensions: 9 x 6.2 x 0.7 inches
• Product Description
  
  This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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[ابو ابراهيم]

Particulate Interactions in Dry Powder Formulation for Inhalation

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Product Details​

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• Hardcover: 264 pages
• Publisher: Informa Healthcare; 1 edition (October 26, 2000)
• Language: English
• ISBN-10: 0748409602
• ISBN-13: 978-0748409600

Product Description​

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Drug delivery efficiency is dependent on drug particulate interactions. This book discusses factors affecting particulate interactions and particle-fluid interaction in the respiratory tract.​

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice

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Product details​

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• Hardcover: 978 pages
• Publisher: Academic Press; 1 edition (12 Jan 2009)
• Language English
• ISBN-10: 0444532420
• ISBN-13: 978-0444532428
• Product Dimensions: 27.7 x 21.8 x 4.1 cm
• Product Description
  
  This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:
  
  Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms
  
  Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies
  
  New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development
  
  The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards
  
  It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter
  
  A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

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Quality and Costs handbook

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This section discusses how quality has an impact on the costs of goods and services in an organization.Section 7, Quality and Income,addresses the issue of quality and sales revenue. Thus, the two sections provide a framework of how quality is related to the total financial picture of an organization. We identify and measure the costs associated with poor quality for three reasons: to quantify the size of the quality problem to help justify an improvement effort, to guide the development of that effort, and to track progress in improvement activities. Among the concepts and methodologies covered are traditional categories of quality costs, a broadened concept of categories including lost revenue and process capability costs, activity-based costing, data collection methods, return on quality, presentation of findings, gaining approval for an improvement effort, using cost data to support continuous improvement, optimum quality level, and reporting cost data. The underlying theme in the section is the use of quality-related costs to support a quality improvement effort rather than as a system of reporting quality costs.​

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Pharmacy Management: Essentials for All Practice Settings, Second Edition

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Product Details​

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• Paperback: 640 pages
• Publisher: McGraw-Hill Medical; 2 edition (August 26, 2008)
• Language: English
• ISBN-10: 0071494367
• ISBN-13: 978-0071494366
• Product Dimensions: 9.1 x 7.3 x 1.1 inches

Review​

.,."it is a valuable, easy to use book that should be successful in the marketplace. It is superior to the earlier edition and to other, currently available management books. It is a plus that nearly all examples and cases use pharmacy settings."--"Doody's Review Service," .​

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Review​

"...it is a valuable, easy to use book that should be successful in the marketplace. It is superior to the earlier edition and to other, currently available management books. It is a plus that nearly all examples and cases use pharmacy settings."--Doody's Review Service (Doody's​

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Pharmaceutical Dosage Forms: Tablets, Vol. 3

Product Details​

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• Hardcover: 584 pages
• Publisher: Informa Healthcare; 2 edition (July 27, 1990)
• Language: English
• ISBN-10: 082478300X
• ISBN-13: 978-0824783006
• Product Dimensions: 10 x 7.1 x 1.3 inches
• Shipping Weight: 2.2 pounds

Review​

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. . .This work is a significant expansion and updating of the first edition. . . . . .This book is the best and most complete in the field and as such can be recommended as the reference compendium for professionals working in tablet making. Scientists who are relatively new in the field will also find this an excellent source of information.​

---Journal of Controlled Release​

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Product Description​

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Complete in 3 volumes. Pharmaceutical technology. 14 Contributors.​

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Pharmaceutical Dosage Forms: Tablets, Vol. 2

Product Details​

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• Hardcover: 640 pages
• Publisher: Informa Healthcare; 2 edition (March 30, 1990)
• Language: English
• ISBN-10: 0824782895
• ISBN-13: 978-0824782894
• Product Dimensions: 10 x 7.2 x 1.4 inches

Review​

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. . .Volume 2. . .discusses processes employed in tablet manufacturing, bioavailability and compression tooling. . . .highly recommended for people involved in tablet technology. . .also a very useful source of information for undergraduate and graduate students in pharmacy. . .a reference for product development, hospital pharmacists and regulatory personnel. . .most useful for industrial manufacturing pharmacists and chemists.​

---The Canadian Journal of Hospital Pharmacy​

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Product Description​

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H.H. Lieberman Associates, Inc., Livingston, New Jersey. 'Tablets' complete in 3 volumes. Pharmaceutica​

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[ابو ابراهيم]

Pharmaceutical Dosage Forms: Tablets, Volume 1

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Details of Book: Pharmaceutical Dosage Forms: Tablets, Volume 1, 2nd Edition Book: Pharmaceutical Dosage Forms: Tablets, Volume 1, 2nd Edition​

Author: Lieberman​

ISBN: 0824780442​

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ISBN-13: 9780824780449​

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, 978-0824780449​

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Binding: Hardcover​

Publishing Date: 2005​

Publisher: Marcel Dekker Inc​

Language: English​

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[ابو ابراهيم]

Pharmaceutics: The Science of Dosage Form Design

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Product details​

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• Paperback: 752 pages
• Publisher: Churchill Livingstone; 2 edition (30 Oct 2001)
• Language English
• ISBN-10: 0443055173
• ISBN-13: 978-0443055171

Review​

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"Aulton's 'Pharmaceutics' is essential reading for every pharmacy student. It makes a very diverse, dry subject area into a comprehensible, more attractive one in just one test. It is clearly written at an appropriate level for both those new to the subject area and those more advance. It is both informative and descriptive, providing a basic understanding of pharmaceutics which is vital to all pharmacists and pharmaceutical scientists...The high recommendations of Aulton 'Pharmaceutics' by both lecturers and peers are clearly justified." "3rd Year Pharmacy Student," Welsh School of Pharmacy, Cardiff, March 2004​

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Product Description​

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A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. Pharmaceutics in its broadest sense is the art of the apothecary or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture and the elimination of micro-organisms from the products. This books encompasses all of those areas and pays particular attention to the design of dosage forms and their manufacture.​

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[ابو ابراهيم]

Pharmaceutical Manufacturers: An International Directory

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Product Details​

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• Hardcover: 298 pages
• Publisher: William Andrew (January 14, 1996)
• Language: English
• ISBN-10: 0815513844
• ISBN-13: 978-0815513841

Review​

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“…the pharmaceutical industry is very dynamic…”—Unlisted Drugs. “…high quality…”-Pharm. Ind.​

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Product Description​

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This international directory of pharmaceutical manufacturers includes 1,046 firms in 50 countries. They are arranged alphabetically by country and company name.​

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In addition to name and address, other information such as telephone and fax number, and key personnel are also listed, where available.​

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Completing the directory, is a listing of 124 Contract Manufacturers in 19 countries of ethical and/or non-prescription pharmaceuticals. These are arranged alphabetically by country and company name.​

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