Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.


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Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

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The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.


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Good Design Practices for GMP Pharmaceutical Facilities

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.


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Good Laboratory Practice Regulations Vol 69

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation.

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British Pharmacopoeia 2009

"The British Pharmacopoeia" ("BP") 2009 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK pharmaceutical quality standards. It is an essential reference for anyone involved in pharmaceutical research, development, manufacture and testing, and plays a vital role in ensuring that all medicinal substances on the UK market meet standards of safety, quality and efficacy.The "BP" comprises monographs, which set out the mandatory standards for active substances, excipients and formulated preparations, together with supporting General Notices, Appendices (test methods, reagents, etc) and Reference Spectra. Detailed information and guidance on various aspects of current pharmacopoeial policy and practice are provided in the Supplementary Chapters of the "BP".The "BP" is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition comprises a five-volume boxed set containing the "BP" in four volumes and the "BP" (Veterinary) volume, plus single user access to the "BP" Online, the dedicated BP website. The online format is easy to network, allowing access for a specified number of users or across an entire organisation site.Following registration - using the ID code supplied with the hard copy - customers will be granted a single user licence to access BP on-line and will have the option to receive the CD-ROM, which contains the whole of the current "British Pharmacopoeia".It is effective as of 1 January 2009. It includes: a significant number of new UK monographs; all "European Pharmacopoeia 6th Edition" material up to and including "Supplement 6.2" integrated into the text of "BP 2009"; new and revised monographs for Complementary, Herbal and Homoeopathic medicines with their own section in Volume III; and networking with full technical support from TSO, the publisher of the "BP". The on-line version delivers the complete text of the "British Pharmacopoeia and European Pharmacopoeia" standards to your PC. The new features include an alphabetical index, user-friendly search interface design, and a facility to create a 'My BP' section." British Pharmacopoeia 2009" eBook - "The complete British Pharmacopoeia 2009" is now available exclusively to "BP 2009" purchasers in an innovative new format. The eBook is greatly suited to this large reference text making the information contained within it available to all of those who wish to access it on the move and away from their desks.British Pharmacopoeia 2009 Concurrent Licence (Online) - "The British Pharmacopoeia" is available as a network licence which can be used on a concurrent user basis. It allows a designated number of staff simultaneous access to the online version of the "British Pharmacopoeia 2009". Once set up, your workforce can then start using the BP at their convenience.

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Dekker Encyclopedia of Nanoscience and Nanotechnology - 5 Volume Set

Placing specialists at the forefront of the nanoscience revolution, this reference identifies current challenges and development paths sure to influence fields ranging from materials and surface science, chemistry, and biomedicine to computer technology, information processing, and mechanical, optical, and electrical engineering-examining the design, application, and utilization of devices, techniques, and technologies critical to research at atomic, molecular, and macromolecular levels ranging from 1-100 nanometers.

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http://rapidshare.com/files/117703166/encyclo_nanosc_tech.part1.rar

http://rapidshare.com/files/117708177/encyclo_nanosc_tech.part2.rar

Pharmavision2020

Pharmaceutical Experimental Design And Interpretation

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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Opthalmic Drug Delivery Syastem, Second Edition

Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.

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Physical Pharmacy

his is a revision guide for students giving bullet points of basic information on physical pharmacy 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, "Physicochemical Principles of Pharmacy", this title is a concise guide providing the physicochemical background to the design and use of pharmaceutical dosage forms.

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Handbook of Cosmetic Science and Technology, Third Edition

Edited by a team of experienced and internationally renowned contributors, the updated Third Edition is the standard reference for cosmetic chemists and dermatologists seeking the latest innovations and technology for the formulation, design, testing, use, and production of cosmetic products for skin, hair, and nails.

New features in the Third Edition:

39 new chapters reorganized by skin functions descriptions of ingredients, products, efficacy measurement, and mechanisms in each chapter revised chapters on skin types, skin perception, and targeted products new chapters on skin aging and cosmetics for the elderly strong emphasis on testing and current methods used for testing, and the evolution of instruments for skin and hair testing new ingredients, delivery systems, and testing methodologies information on skin physiology and cosmetic product design interactions affecting and attributed to cosmetic products cosmetic ingredients, vehicles, and finished products difference between pure cosmetics for enhancement and cosmetics used to treat high quality standards in cosmetic products that improve appearance, protect their targets, and maintain natural functions.

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Encyclopedia of Pharmaceutical Technology, Volume 20

AAI, Inc., Wilmington, NC. An encyclopedia of pharmaceutical technology, offering a collection of entries on a number of subjects, from drug delivery to process chemistry in the pharmaceutical industry. Lists the contents for all 20 volumes in the set. DNLM: Chemistry, Pharmaceutical-encyclopedias.

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Pharmacy Case Studies

Whilst most pharmacy undergraduate texts are subject specific, "Pharmacy Case Studies" encourages students to take an integral approach to pharmacy via a series of pharmacy cases. Knowledge gained within the individual areas of law and ethics, pharmaceutics, pharmacology and pathology are tested by each example, bringing together all areas taught on the degree course. Each chapter contains five case studies, starting with uncomplicated cases and increasing in complexity as they expand.

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Physicochemical Principles of Pharmacy, 4th Edition

Physical chemistry is the basis of rational pharmaceutical formulation and processing, and is fundamental to understanding the complexities of drug delivery and drug absorption. This textbook presents the physiochemical principles useful to the modern pharmaceutical scientist and pharmacist.

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Clinical Pharmacology & Therapeutics Journal ~ Volume 85, Issue 5, May 2009

This issue discusses drug delivery and how advances in the pharmaceutical sciences and other scientific fields have enabled substantial progress in this field. Targeting the best route or providing a variety of routes of drug administration presents an array of benefits, such as enhanced drug administration and bioavailability, improved patient acceptance and compliance, decreased toxicity, and precise therapeutic targeting. Technologies enabling drug delivery are now commonly used to create and extend markets, and the pharmaceutical industry is turning to drug delivery to extend the revenueearning lifetime of their biggest products. Growth opportunities for drug delivery systems extend into all therapeutic classes of pharmaceuticals and encompass a wide range of compounds and formulations, presenting many options in the world market. The discovery of better delivery systems in conjunction with the discovery of novel pharmacological compounds will advance disease diagnosis and treatment.

In This Issue

Top of pageRegulating combination products

The US Food and Drug Administration (FDA) guidance on medical devices ensures the safety, efficacy, and security of drugs released to the public. The introduction of combination products has convoluted the approach historically used by the FDA to regulate single-entity products. Lauritsen details the complications faced by the agency in regulating combination products and the most important issues that must be addressed. See page 468

Top of pageAppraising the safety and efficacy of drug-eluting stents

The use of drug-eluting stents (DESs) in procedures has significantly increased worldwide since their approval by the US Food and Drug Administration in 2003. Although DESs are considered superior to bare-metal stents, safety concerns remain in the wake of reports of late stent thrombosis and myocardial infarction. In response to these concerns, new-generation DESs have been approved and made available for use. Using published clinical data, Maluenda et al. appraise the safety and efficacy of several DESs. See page 474

Top of pageEffect of multiple alleles on efavirenz disposition

Efavirenz (EVF), a non-nucleoside reverse transcriptase inhibitor used for treatment of HIV-1 infection, is primarily metabolized by CYP2B6. Although CYP3A4/3A5 has also been associated with higher EVF exposure, the influence of CYP2A6 polymorphism on EVF pharmacokinetics has not yet been determined. Arab-Alameddine et al. discuss the impact of multiple alleles on EVF disposition. See page 485

Top of pageThe growing role of nanoparticles in brain tumor diagnosis and therapy

Nanoparticle-based contrast agents designed for use in diagnosing brain tumors using magnetic resonance imaging (MRI) are capable of providing better information on the extent of tumor. The potential to visualize portions of tumors usually not detectable with conventional MRI makes nanoparticles of interest for advancing the diagnosis, operative management, and adjuvant therapy of brain tumors. Orringer et al. discuss the application of nanoparticles to brain tumor diagnosis and therapy and the many reasons that nanoparticles offer the next frontier in the treatment of brain tumors. See page 531

Top of pageBiologics in cardiovascular regenerative medicine

Stem cell–based cardiovascular regenerative medicine plays an integral role in therapy aimed at achieving structural and functional repair of the myocardium. Although experience gained in the clinical setting has shown stem cell–based cardiovascular regenerative medicine to be feasible and safe, the structural and functional benefits of such therapy have not yet reached their full potential. The very low rate of cell retention by the recipient myocardial tissue justifies review of the accumulated data to guide future developments aimed at overcoming this limitation and achieving a better outcome of stem cell delivery. See page 548

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Pharmaceutical Biotechnology

Conceiving an up-to-date pharmaceutical biotechnology textbook that trains next-generation pharmacy students, as well as updating pharmacists and pharmaceutical scientists … is a formidable challenge, and one which the editors … have accomplished to a high standard … . … [Many chapters] contain industrial case-studies of blockbuster drugs, thus giving this textbook an industrial scope that is difficult to find elsewhere. All the chapters are easy to read and well illustrated to aid understanding of the interdisciplinary content. Each chapter is authored by experts in the field and contains a good introductory section and an in-depth discussion of each topic.

The field of pharmaceutical biotechnology is a rapidly evolving subject. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for a spectrum of serious diseases such as cancer, viral infections, cardiovascular and hereditary disorders. In addition, we are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy.

Completely revised and updated, this introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use.

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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

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Nanotechnology in Drug Delivery

The reader will be introduced to various aspects of the fundamentals of nanotechnology based drug delivery systems and the application of these systems for the delivery of small molecules, proteins, peptides, oligonucleotides and genes. How these systems overcome challenges offered by biological barriers to drug absorption and drug targeting will also be described.

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

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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