Pharmacy Minds: February 2010

Wednesday, February 17, 2010

A to Z Drug Facts

Annual pocket-sized reference presents the newest FDA approvals, latest indications, dosages, side effects, and patient care considerations. Includes current data on more than 3,000 drugs. RX, over-the-counter, and investigational and orphan drugs are also included as well as protocols and guidelines.

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Drug Facts and Comparisons 2007

Drug Facts and Comparisons contains up-to-date, comprehensive information on over 22,000 Rx and almost 6,000 OTC items grouped by therapeutic category for ease of comparison. The annual hardbound edition features the Color Locator, a full-color section of photos of the most frequently prescribed tablets and capsules organized by color for easy visual identification. The book answers questions about: actions, indications and contraindications; warnings and precautions; interactions between drugs; adverse reactions; administration, dosage, and overdosage; patient information. Comparisons are provided: Of drug to drug; of different dosage forms; name brands are compared to name brands and to generics. Facts and Comparisons are also given on Centers for Disease Control biologicals and antiparasitic drugs; IV solutions; therapeutic and diagnostic ophthalmic preparations; diagnostic aids and radiographic contrast media and products; NCI investigational chemotherapeutic drugs; combination cancer chemotherapy regimens.

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Indian Medicinal Plants: An Illustrated Dictionary

In 2004, Springer-Verlag Heidelberg published C.P.Khare’s "Encyclopedia of Indian Medicinal Plants" which contained 400 monographs comprising classical as well as contemporary research findings.

"Indian Medicinal Plants. An Illustrated Dictionary" is the second major one-volume reference work by C.P.Khare which has been dedicated to the distinguished scientist, Dr. A.P.J.Abdul Kalam, who did pioneering work by reviving the glory of medicinal and aromatic plants in Rashtrapati Bhavan.

Scientific monographs of "The Wealth of India" series (17 volumes) have been capsulised in the dictionary and corroborated with the judicious findings of German Commission E, European Cooperative on Phytotherapy (ESCOP) and WHO. Therapeutic leads, active indications and contraindications are salient features of the core text. These are based on herbal pharmacopoeias, compendiums and latest editions of standard reference works like "PDR for Herbal Medicines," "(Laurance)Review of Natural Products", "Natural Medicines ComprehensiveDatabase". Leads for further research have been provided at a number of places.

The Dictionary is the first updated source of Ayurvedic, Unani and Siddha synonyms of their botanical counterparts, after a gap of more than 30 years. The synonyms which appeared in "The Wealth of India" series (1948-1976) and in Chopra’s "Glossary of Indian Medicinal Plants" (1956) have been updated till January, 2007.

More than 2000 medicinal plants of "The Ayurvedic Formulary of India" and "The Ayurvedic Pharmacopoeia of India" and more than 100 species of non-Indian origin, incorporated in "National Formulary of Unani Medicine" have been covered in the Dictionary. Divergent sources of Ayurvedic, Unani and Siddha herbs have been identified and a number of controversies have been sorted out.

Pharmacognosy experts have selected important herbs, which were specially collected from leading pharamaceutical companies and pharmacopoeial laboratories and included in the dictionary as four colour photographs under the "Crude Herb Identification Guide" section. This is a unique feature and makes it an exclusive treat.

The Dictionary has been presented in a user-friendly format, as a compact, handy, easy to use and moderately priced one-volume reference work. It unfolds hidden virtues and potentials of Indian herbs for busy professionals, researchers, practitioners of herbal as well as modern medicine, and library frequenters. It will prove a ready information source for students of botany, economic botany, pharmacy, agricultural and medical sciences, who aspire to have an edge over others and are keen to keep themselves abreast of the times.

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British Pharmacopoeia 2007

The British Pharmacopoeia (BP) 2007 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK quality standards. It is an essential reference for anyone involved in pharmaceutical Research & Development, manufacturing 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 is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition package contains a boxed five volume set with a separate Veterinary volume, a CD-ROM and access to a comprehensible, regularly updated website. Both the CD-ROM and online formats are easy to network for access across your organisation.

There will not be an edition of the BP entitled 'British Pharmacopoeia 2006'. In order to improve the alignment of the published edition with theeffective date of its contents, the forthcoming edition is entitled 'British Pharmacopoeia 2007'.

Key features:

Extensive Revisions including 30 new BP texts
New Supplementary Chapters containing general guidance on Unlicensed Medicines and Method Validation
First BP monograph for Traditional Chinese Medicines
All European Pharmacopoeia 5th edition material up to and including Supplement 5.5 integrated into the text of BP 2007
Value-for-money networking with full technical support from the publishers
CD-ROM and website deliver the complete text of the British Pharmacopoeia, British Approved Names and European Pharmacopoeia standards directly to your PC

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Japanese Pharmacopoeia (Jp Xiv) (Pharmacopoeia of Japan)

Publisher: Society of Japanese Pharmac
Number Of Pages: 1357
Publication Date: 2002-01
Sales Rank: 3114417
ISBN / ASIN: 4840806721
EAN: 9784840806725
Binding: Hardcover
Manufacturer: Society of Japanese Pharmac
Studio: Society of Japanese Pharmac

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Stockley's Drug Interactions 7th Edition

Stockley's Drug Interactions, produced within the Martindale Editorial Team under Karen Baxter, remains the world's most comprehensive and authoritative reference book on drug interactions.

Contains detailed yet concise monographs
Covers interactions between therapeutic drugs, proprietary medicines, herbal medicines, foods, drinks, pesticides and some drugs of abuse
Based on published sources and fully referenced
A typical monograph contains a summary, clinical evidence for the interactions under discussion, the probable mechanism, clinical importance and management
Covers over 14,000 drug interactions
Contains over 2,800 monographs
Includes 17,600 references

Stockley's Drug Interactions provides the busy healthcare professional with quick and easy access to clinically relevant, evaluated and evidence-based information on drug interactions.

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Fiedler Encyclopedia of Excipients: For Pharmaceuticals, Cosmetics and Related Areas

Fiedler Encyclopedia of Excipients: For Pharmaceuticals, Cosmetics and Related Areas

The two-volume encyclopedia offers a detailed description of properties, analyses and characteristic data for more than 17,000 excipients used in the manufacture of pharmaceuticals, cosmetics and related products. In addition, pharmacological and toxicological properties as well as allergy-inducing reactions are evaluated. Information on manufacturers is given in a directory at the end of the second volume.

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The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals

The Merck Index is a one-volume encyclopedia of chemicals, drugs and biologicals that contains more than 10,000 monographs. Each monograph in this authoritative reference source is a concise description of a single substance or a small group of closely related compounds.

Compounds included:

• human and veterinary drugs

• biotech drugs and monoclonal antibodies

• substances used for medical imaging

• biologicals and natural products

• plants and traditional medicines

• nutraceuticals and cosmeceuticals

• agriculturals, pesticides and herbicides

• Organic chemicals used in research

• Food additives and supplements

• dyes, colors and indicators

• environmentally significant substances

Information provided:

• chemical, common and generic names

• Over 15,000 trademarks and associated companies

• CAS Registry Numbers for over 12,000 compounds

• Over 8,500 chemical structures

• molecular formulae, weights and percentage composition

• capsule statements identifying compound classes and scientific significance

• scientific and patent literature references

• physical and toxicity data

• therapeutic and commercial uses

• caution and hazard information

In addition, there are more than 700 new and completely revised monographs, thousands of new references, trademarks and uses added to existing monographs. Now includes a companion CD-ROM which features 989 monographs no longer available in print, organic name reactions, supplemental tables and a new user interface for user-friendly searching.

Features of the CD:

Searchable by keywords, references, and numerical properties
Search the complete contents of the 14th edition, plus nearly a thousand monographs archived from previous editions
Comes with a free one-year subscription to the Merck Index Internet Edition
Windows-compatible CD powered by CambridgeSoft's ChemFinder
Extensively revised supplemental tables now including acronyms, vaccines, and physical constants
More than 70 pages of hard to find information in one easy-to-use place

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Herb Navigator-Materia Medica

User friendly revolutionary program that will allow you quickly and easily improve the accuracy of your clinical observations, diag- nosis and herbal prescriptions.

With a few clicks of the mouse, you can quickly and easily see more clearly the possibilities and best use of interconnected formulas, conditions, and actions.

Over 140 herbs and over 400 specific ailments are referenced
Search by indication
Unique search by multiple actions
The program offers you the ability to add your own data.
Preparation methods are given for each herb
Adult dosage ranges for all appropriate preparations are given

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British National Formulary 56

Compiled with the advice of clinical experts, the British National Formulary (BNF) provides up-to-date guidance on prescribing, dispensing and administering medicines.

The BNF details medicines prescribed in the UK, with special reference to their uses, cautions, contra-indications, side-effects, dosage and relative costs.

Updated every six months, the BNF reflects current best practice as well as legal and professional guidelines relating to the use of medicines. It is intended for use by prescribers, pharmacists and other healthcare professionals.

Designed for rapid reference
Authoritative, impartial and, where available, evidence-based advice on prescribing, dispensing and administering medicines
Updated twice a year to reflect promptly changes in product availability as well as emerging safety concerns and shifts in clinical practice

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European Pharmacopoeia, 4th edition

The European Pharmacopoeia is a single reference work for the quality control of medicines in Europe. Several legal texts make the European Pharmacopoeia mandatory:A Convention on the Elaboration of a European Pharmacopoeia ratified in 2003 by 31 European countries and the European Union; European Union directives 2001/83/EC and 2001/82/EC,on medicines for human use and for veterinary use, respectively, maintain the mandatory character of European Pharmacopoeia specifications on medicines as regards their qualitative and quantitative composition and the tests to be carried out on these medicines, the raw materials used in production and the intermediates of synthesis. All producers of medicines or substances for pharmaceutical use therefore must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe. The texts of the European Pharmacopoeia are legally binding and compliance is enforced by the administrative or juridical authorities. The national authorities of the member states are bound to apply them if necessary replacing any national monograph on the same subject.

The 4th Edition consists of an initial volume 2002 (4.0) and a collection of 8 non-cumulative supplements (4.1) published three times a year following the decisions of each session of the European Pharmacopoeia Commission. With supplement 4.6, the 4th Edition comprises 1750 specific monographs, 285 general methods illustrated by figures or chromatograms and 2140 reagents. Every 4 months a new volume enters into force.

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The Pharmacopoeia of the United States of America: Facsimile of the First Edition (1820)

The Pharmacopoeia of the United States of America: (The United States Pharmacopoeia). By General Medical Convention, United States Pharmacopeial Convention Committee of Revision, United States Pharmacopœial Convention, General Convention for the Formation of the American Pharmacopoeia, National Convention for Revising the Pharmacopoeia Published by United States Pharmacopoeial Convention, Inc., 1820-1975., 1820

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AHFS Drug Information

Annual reference provides a comprehensive evidence-based collection of more than 1,000 drug monographs. Each listing includes FDA-approved uses, evidence-based coverage of off-label uses, drug interactions, cautions, toxicity, dosage recommendations, coverage of pharmacology and pharmacokinetics, and more. For pharmacists and other healthcare professionals. Softcover.

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Martindale: The Complete Drug Reference, 35th Edition 2 Volume Set

Provides evaluated information on drugs and medicines used throughout the world.

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A to Z Drug Facts: Published by Facts and Comparisons

This compact, portable, alphabetically organized drug reference provides quick access to current, reliable information on more than 4,500 commonly prescribed medications. Each drug monograph is divided into pharmacological and patient care considerations, and includes action, indications, contraindications, route/dosage, interactions, lab test interferences, adverse reactions, precautions/warnings, administration/storage, assessment/interventions, and patient/family education. Icons and a second color are used to help readers quickly locate the information they are looking for. A color identification section enables readers to identify drugs by appearance. Coverage includes the newest FDA approvals, investigational and orphan drugs, and indications for labeled, unlabeled, and orphan uses.

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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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The Japanese Pharmacopoeia Fifteenth Edition (JP XV)

This is the English version of the 15th edition of the "JapanesePharmacopoeia". It provides the official Japanese standard for the description and quality of drug substances and products. It contains over 1,300 articles regarding: general rules for preparations; processes and apparatus; monographs on drugs; and infrared reference spectra and ultraviolet-visible reference spectra.

Official Monographs provides 1483 articles, including 102 articles newly added and 8 articles deleted. Comprises the following items in order: The Ministry of Health, Labour and Welfare Ministerial Notification; Contents; Preface; General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs, including Monographs for Crude Drugs; Infrared Reference Spectra; Ultraviolet-visual Reference Spectra; General Information; Atomic Weight Table (2004) and Standard AtomicWeights 2004 as Appendix ; and Cumulative Index (English, Latin and Japanese titles).

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European Pharmacopoeia 5th Ed. Main Volume 5.0, 2005

The purpose of the Pharmacopoeia is to promote public health, by the provision of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines.

The monographs and other texts are designed to be appropriate to the needs of regulatory authorities, those engaged in the control of quality, and the manufacturers of starting materials and medicinal products.

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USP NF 2009 (United States Pharmacopeia 32 / National Formulary 27)

USP NF 2009 (United States Pharmacopeia 32 / National Formulary 27)

The United States Pharmacopeia–National Formulary and its Supplements become official six months after being released to the public. The USP–NF, which is released on November 1 of each year, becomes official on May 1 of the following year.

This change was adopted to give users more time to bring their methods and procedures into compliance with new and revised USP–NF requirements.

The table below describes the new official dates. The 2008 USP31–NF26, and the Supplements and Interim Revision Announcements (IRAs) to that edition, will be official until May 1, 2009, at which time the USP32–NF27 becomes official.

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Martindale: The Complete Drug Reference, 36th Edition

This book provides reliable, unbiased and evaluated information ondrugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

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ndian Pharmacopoeia 1996

Indian Pharmacopoeia 1996

DETAILS

ISBN: 8190065831

Place of Publication: New Delhi

Publisher: The Controller of Publications

Edition: 1st ed.

Year of Publication: 2003

Physical Description: 140p.

Book Format: Hardcover

Language: English

SYNOPSIS

The latest edition of the Indian Pharmacopoeia was published in 1996. It was updated by additions and amendments introduced through addendum 2000. Under the Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia is the legally recognised book of standards for the quality of drug substances and their preparations included therein. In view of the rapid developments is pharmaceutical sciences and technology, it became necessary to make further changes in the existing compendium. Addendum 2002 amends as well as adds new drugs and preparations to the Indian pharmacopoeia 1996 with a view to keeping the pharmacopoeia updated to the extent possible. Besides amending the existing monographs and appendices, it contains 19 new monographs including monographs of 12 antiretroviral drugs and 7 formulations of these substances. A new appendix on residual solvents has been incorporated. Some monographs have undergone major amendments. The appendix on high performance liquid chromatography has been replaced with a new version which also includes the ion chromatography. The Addendum 2002 is a companion volume to the Indian pharmacopoeia which is indispensable for all concerned with the quality of drugs.

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Password of RAR File is : www.w5awarez.com

Tuesday, February 16, 2010

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical

The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.

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http://rapidshare.com/files/42097466/Computer_Systems_Validation.zip

Facility Validation: Theory, Practice, and Tools

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.

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http://rapidshare.com/files/47443195/Facility_Validation.zip

In Silico Technologies in Drug Target Identification and Validation

The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets. These in silico methods are often predictive, yielding faster and less expensive analyses than traditional in vivo or in vitro procedures. In Silico Technologies in Drug Target Identification and Validation addresses the challenge of testing a growing number of new potential targets and reviews currently available in silico approaches for identifying and validating these targets. The book emphasizes computational tools, public and commercial databases, mathematical methods, and software for interpreting complex experimental data. The book describes how these tools are used to visualize a target structure, identify binding sites, and predict behavior. World-renowned researchers cover many topics not typically found in most informatics books, including functional annotation, siRNA design, pathways, text mining, ontologies, systems biology, database management, data pipelining, and pharmacogenomics. Covering issues that range from prescreening target selection to genetic modeling and valuable data integration, In Silico Technologies in Drug Target Identification and Validation is a self-contained and practical guide to the various computational tools that can accelerate the identification and validation stages of drug target discovery and determine the biological functionality of potential targets more effectively.

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http://rapidshare.com/files/48860200/Silico_tech_drug_target_identif_validation.rar

Development and Validation of Analytical Methods

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.

Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.

Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.

This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

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Validation and Qualification in Analytical Laboratories, Second Edition

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

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http://rapidshare.com/files/67987349/Vali_Quali_Anal_Lab.zip

Pharmaceutical Process Validation: An International Third Edition

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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http://rapidshare.com/files/71178252/Pharmaceutical_Process_Validation_TE.zip

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

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http://rapidshare.com/files/75520995/Valid_Pharma_Sys.zip