Compatibility Of Pharmaceutical Solutions And Contact Materials

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Compatibility of Pharmaceutical Solutions and Contact Materials

Author : Dennis Jenke
Publisher : John Wiley & Sons
ISBN 13 : 1118679474
Total Pages : 400 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Compatibility of Pharmaceutical Solutions and Contact Materials by : Dennis Jenke

Download or read book Compatibility of Pharmaceutical Solutions and Contact Materials written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2013-02-26 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.

Extractables and Leachables

Author : Dennis Jenke
Publisher : John Wiley & Sons
ISBN 13 : 1119605075
Total Pages : 468 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Extractables and Leachables by : Dennis Jenke

Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.

Extractables and Leachables

Author : Dennis Jenke
Publisher : John Wiley & Sons
ISBN 13 : 1119605105
Total Pages : 468 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Extractables and Leachables by : Dennis Jenke

Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-07-14 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Author : Vitthal S. Kulkarni
Publisher : Academic Press
ISBN 13 : 012801072X
Total Pages : 256 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Essential Chemistry for Formulators of Semisolid and Liquid Dosages by : Vitthal S. Kulkarni

Download or read book Essential Chemistry for Formulators of Semisolid and Liquid Dosages written by Vitthal S. Kulkarni and published by Academic Press. This book was released on 2015-10-15 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. Unique coverage of the underlying chemistry that makes possible stable dosages Quality content written by experienced experts from the drug development industry Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products

The Syringe Driver

Author : Andrew Dickman
Publisher : Oxford University Press
ISBN 13 : 0198733720
Total Pages : 609 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis The Syringe Driver by : Andrew Dickman

Download or read book The Syringe Driver written by Andrew Dickman and published by Oxford University Press. This book was released on 2016 with total page 609 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a valuable reference source, providing a comprehensive review of syringe driver use and administration of drugs via CSCI, a safe and effective way of drug administration when other routes are inappropriate.

Handbook of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420048457
Total Pages : 258 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Sarfaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, emul

Pharmaceutical Formulation

Author : Geoffrey D Tovey
Publisher : Royal Society of Chemistry
ISBN 13 : 1849739412
Total Pages : 432 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Formulation by : Geoffrey D Tovey

Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Handbook of Pharmaceutical Salts Properties, Selection, and Use

Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
ISBN 13 : 9783906390581
Total Pages : 392 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis Handbook of Pharmaceutical Salts Properties, Selection, and Use by : P. Heinrich Stahl

Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.

Pharmaceutical Dosage Forms

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 1482281783
Total Pages : 1168 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Pharmaceutical Dosage Forms by : Sandeep Nema

Download or read book Pharmaceutical Dosage Forms written by Sandeep Nema and published by CRC Press. This book was released on 2010-08-26 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products

Excipient Applications in Formulation Design and Drug Delivery

Author : Ajit S Narang
Publisher : Springer
ISBN 13 : 3319202065
Total Pages : 700 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Excipient Applications in Formulation Design and Drug Delivery by : Ajit S Narang

Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Pharmaceutical Dosage Forms - Parenteral Medications

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 1420086448
Total Pages : 424 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Dosage Forms - Parenteral Medications by : Sandeep Nema

Download or read book Pharmaceutical Dosage Forms - Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Chemical Engineering in the Pharmaceutical Industry

Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 111928550X
Total Pages : 1435 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Handbook of Pharmaceutical Manufacturing Formulations

Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Safaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Cancer Chemotherapy by Infusion

Author : J.J. Lokich
Publisher : Springer Science & Business Media
ISBN 13 : 940093193X
Total Pages : 762 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Cancer Chemotherapy by Infusion by : J.J. Lokich

Download or read book Cancer Chemotherapy by Infusion written by J.J. Lokich and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemotherapy for-cancer is in a state of evolution. Because some cancers can now be cured with chemotherapy as a singular modality, this therapy can no longer be viewed as simply a palliative contribution. Chemotherapy has assumed an important role as an adjuvant to other modalities, including both surgery and radiation therapy. For some tumors, the primary application of chemotherapy in a combined modality approach to curative therapy has resulted in the application of less radical surgery while achieving substantial of relatively rare tumors such as cure rates. Nonetheless, with the exception childhood tumors, hematologic malignancies, and testicular cancer, the effec tiveness of chemotherapy in most tumors is severely limited. At the cellular level, greater understanding of the specific mechanism of tumor cell killing and of the phenomenon of drug resistance are elusive, critical ingredients in the improvement of effectiveness in cancer chemotherapy. Prolonging the exposure time of the tumor cell to drugs is a concept that was addressed in the early phases of the development of chemotherapy. How ever, technological limitations inhibited the broader application of chemother apy by infusion until recent years. Also, the convenience of intermittent ther apy on an outpatient basis, with the predominant theory of drug effect based on a dose response as well as the proven effectiveness of this schedule in some tumors, has slowed the process of subjecting infusion chemotherapy to the rigors of clinical trials.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Author : Hamid Mollah
Publisher : John Wiley & Sons
ISBN 13 : 0470552344
Total Pages : 432 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah

Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-03-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Handbook of Pharmaceutical Excipients

Author : Raymond C. Rowe
Publisher : Amer Pharmacists Assn
ISBN 13 : 9781582121352
Total Pages : 888 pages
Book Rating : 4.1/5 (213 download)

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Book Synopsis Handbook of Pharmaceutical Excipients by : Raymond C. Rowe

Download or read book Handbook of Pharmaceutical Excipients written by Raymond C. Rowe and published by Amer Pharmacists Assn. This book was released on 2009-01-01 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.

Martindale

Author : Sean C. Sweetman
Publisher :
ISBN 13 : 9780853697046
Total Pages : 3335 pages
Book Rating : 4.6/5 (97 download)

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Book Synopsis Martindale by : Sean C. Sweetman

Download or read book Martindale written by Sean C. Sweetman and published by . This book was released on 2006-01-01 with total page 3335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced