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Principles Of Parenteral Solution Validation

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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-04-15
ISBN : 0128094125
Language : En, Es, Fr & De

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Book Description :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation Book
Author : E. Clyde Buchanan
Publisher : Amer Soc of Health System
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Principles of Sterile Product Preparation book written by E. Clyde Buchanan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmaceutical Process Validation Second Edition

Pharmaceutical Process Validation  Second Edition Book
Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Release : 1993-01-29
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Principles Practice of Pain Medicine Second Edition

Principles   Practice of Pain Medicine  Second Edition Book
Author : Carol A. Warfield,Zahid H. Bajwa
Publisher : McGraw-Hill Education / Medical
Release : 2004-04-05
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The leading textbook on pain management! A Doody's Core Title! 4 STAR DOODY'S REVIEW! "This is an extraordinarily well-written and comprehensive book. It expands considerably on the first edition, and with its multifaceted and multidisciplinary perspective, it should be an invaluable addition to the library of any practitioner of pain medicine."--Doody's Review Service This comprehensive resource covers every aspect of diagnosing and treating specific pain conditions and syndromes. Features a concise introduction to basic concepts in pain management, plus an expanded section on evaluation and assessment techniques.

Pharmaceutical Process Validation

Pharmaceutical Process Validation Book
Author : Bernard T. Loftus,Robert A. Nash
Publisher : Marcel Dekker Incorporated
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pharmaceutical Process Validation book written by Bernard T. Loftus,Robert A. Nash, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Solid Oral Dose Process Validation

Solid Oral Dose Process Validation Book
Author : Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Jordan Collins
Publisher : Springer
Release : 2018-11-16
ISBN : 3030024725
Language : En, Es, Fr & De

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Book Description :

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

Particle Size Distribution II

Particle Size Distribution II Book
Author : American Chemical Society. Meeting
Publisher : Amer Chemical Society
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Complementing ACS Symposium Series No. 332, Particle Size Distribution, this volume is a compendium of the current work in the field and features the latest technology now in use for particle size distribution assessment. Among the new techniques discussed are capillary hydrodynamic fractionation, field flow fractionation, disc centrifuge photosedimentometry, on-line measurements, fractuals, electrophoretic characterization, image analysis, and electric sensing zone. A review chapter examines turbidimetry, an old technique that has been revitalized with new mathematical approaches. Of interest to coatings scientists; colloid and surface chemists; and polymer, physical, and analytical chemists.

Best Practices for Health System Pharmacy 2003 2004

Best Practices for Health System Pharmacy 2003 2004 Book
Author : American Society of Health-System Pharmacists
Publisher : Amer Soc of Health System
Release : 2003
ISBN : 9781585280551
Language : En, Es, Fr & De

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Book Description :

More than half a century ago, the American Society of Health-System Pharmacists developed its earliest proposed practice standard -- the Proposed Minimum Standards for Pharmacies in Hospitals. Today, ASHP continues to foster concrete improvements in pharmacy practice and in the therapeutic use of drugs with Best Practices for Health-System Pharmacy: Positions and Guidance Documents of ASHP. These guidance documents have stimulated improvements in pharmacy practice and operations, influenced accreditation standards, laws, and regulations (both in the United States and in other countries), and contributed to an awareness among consumers and policymakers of the vital patient care role of pharmacists. Substantial content has been added or revised since the release of the 2002-2003 edition, including new material relating to the pharmacist's role in immunization, use of statins in the prevention of atherosclerotic vascular disease, documenting pharmaceutical care in the patient medical record, strict glycemic control in patients with diabetes, and the recruitment, selection, and retention of pharmacy personnel. Book jacket.

Topley Wilson s Principles of Bacteriology Virology and Immunity General bacteriology and immunity

Topley   Wilson s Principles of Bacteriology  Virology  and Immunity  General bacteriology and immunity Book
Author : William Whiteman Carlton Topley,Sir Graham Selby Wilson
Publisher : Unknown
Release : 1990
ISBN : 9781556642890
Language : En, Es, Fr & De

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Book Description :

Download Topley Wilson s Principles of Bacteriology Virology and Immunity General bacteriology and immunity book written by William Whiteman Carlton Topley,Sir Graham Selby Wilson, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Solid Oral Dose Process Validation Volume Two

Solid Oral Dose Process Validation  Volume Two Book
Author : Ajay Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Marzena Ingram,Jordan Collins
Publisher : Springer
Release : 2019-09-20
ISBN : 9783030274832
Language : En, Es, Fr & De

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Book Description :

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Disinfection Sterilization and Preservation

Disinfection  Sterilization  and Preservation Book
Author : Seymour Stanton Block
Publisher : Williams & Wilkins
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Now in its thoroughly revised, updated Fifth Edition, this volume is a comprehensive, practical reference on contemporary methods of disinfection, sterilization, and preservation and their medical, surgical, and public health applications. More than a third of this edition's chapters cover subjects never addressed in previous editions. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. Close attention is given to infection control problems posed by endoscopes, implants, prostheses, and organ transplantation and to prevention of opportunistic infections in immunocompromised patients. A Brandon-Hill recommended title.

Intravenous Therapy

Intravenous Therapy Book
Author : Intravenous Nurses Society
Publisher : W.B. Saunders Company
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This text addresses special areas of IV therapy, including oncology and pain management, blood and blood components and parenteral nutrition. The book also offers calculations required for parenteral therapies and applies IV therapy to a variety of settings, including home health care and long-term care. in addition, it provides therapy principles for care of paediatric and geriatric patients.

Validation of Aseptic Pharmaceutical Processes

Validation of Aseptic Pharmaceutical Processes Book
Author : Frederick J. Carleton,James P. Agalloco
Publisher : Marcel Dekker
Release : 1986
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Validation of Aseptic Pharmaceutical Processes book written by Frederick J. Carleton,James P. Agalloco, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Stability

Drug Stability Book
Author : Jens Thurø Carstensen
Publisher : Marcel Dekker
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

European Pharmacopoeia

European Pharmacopoeia Book
Author : European Pharmacopoeia Commission
Publisher : Unknown
Release : 2001
ISBN : 9789287143181
Language : En, Es, Fr & De

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Book Description :

Download European Pharmacopoeia book written by European Pharmacopoeia Commission, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Principles and Practice of Medical Therapy in Pregnancy

Principles and Practice of Medical Therapy in Pregnancy Book
Author : Norbert Gleicher
Publisher : McGraw-Hill/Appleton & Lange
Release : 1992
ISBN : 9780838579794
Language : En, Es, Fr & De

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Book Description :

Download Principles and Practice of Medical Therapy in Pregnancy book written by Norbert Gleicher, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Sterilization Technology

Sterilization Technology Book
Author : Robert F. Morrissey,G. Briggs Phillips
Publisher : Springer
Release : 1993-02-28
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR

Quality Assurance for Biopharmaceuticals

Quality Assurance for Biopharmaceuticals Book
Author : Jean F. Huxsoll
Publisher : Wiley-Interscience
Release : 1994-06-21
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.

Pharmaceutical Dosage Forms Parenteral Medications

Pharmaceutical Dosage Forms  Parenteral Medications Book
Author : Kenneth E. Avis,Leon Lachman,Herbert A. Lieberman
Publisher : Unknown
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pharmaceutical Dosage Forms Parenteral Medications book written by Kenneth E. Avis,Leon Lachman,Herbert A. Lieberman, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Plumer s Principles and Practice of Intravenous Therapy

Plumer s Principles and Practice of Intravenous Therapy Book
Author : Ada Lawrence Plumer
Publisher : Lippincott Williams & Wilkins
Release : 2007
ISBN : 9780781759441
Language : En, Es, Fr & De

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Book Description :

Disc contains drug monographs on more than 100 intravenous agents in a printable format for patient teaching and 11 appendices with information on continuing education, governmental regulations, and other subjects relevant to infusion therapy.