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Specification Of Drug Substances And Products

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Specification of Drug Substances and Products

Specification of Drug Substances and Products Book
Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Publisher : Elsevier
Release : 2020-07-23
ISBN : 0081028253
Language : En, Es, Fr & De

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Book Description :

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Specification of Drug Substances and Products

Specification of Drug Substances and Products Book
Author : Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley
Publisher : Elsevier Science Limited
Release : 2013-09
ISBN : 9780080983509
Language : En, Es, Fr & De

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Book Description :

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis Book
Author : Satinder Ahuja,Stephen Scypinski
Publisher : Academic Press
Release : 2001
ISBN : 9780120455553
Language : En, Es, Fr & De

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Book Description :

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release : 2009-03-10
ISBN : 9780080932729
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Pharmaceutical Manufacturing Formulations Third Edition

Handbook of Pharmaceutical Manufacturing Formulations  Third Edition Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2019-12-05
ISBN : 135159351X
Language : En, Es, Fr & De

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Book Description :

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Handbook of Analytical Validation

Handbook of Analytical Validation Book
Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Release : 2012-04-24
ISBN : 142001448X
Language : En, Es, Fr & De

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Book Description :

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules Book
Author : Behnam Davani
Publisher : John Wiley & Sons
Release : 2017-07-12
ISBN : 1119425034
Language : En, Es, Fr & De

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Book Description :

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

NMR in Pharmaceutical Science

NMR in Pharmaceutical Science Book
Author : Jeremy R. Everett,Robin K. Harris,John C. Lindon,Ian D. Wilson
Publisher : John Wiley & Sons
Release : 2015-08-20
ISBN : 1118660242
Language : En, Es, Fr & De

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Book Description :

NMR in Pharmaceutical Sciences is intended to be a comprehensive source of information for the many individuals that utilize MR in studies of relevance to the pharmaceutical sector. The book is intended to educate and inform those who develop and apply MR approaches within the wider pharmaceutical environment, emphasizing the toolbox that is available to spectroscopists and radiologists. This book is structured on the key processes in drug discovery, development and manufacture, but underpinned by an understanding of fundamental NMR principles and the unique contribution that NMR (including MRI) can provide. After an introductory chapter, which constitutes an overview, the content is organised into five sections. The first section is on the basics of NMR theory and relevant experimental methods. The rest follow a sequence based on the chronology of drug discovery and development, firstly 'Idea to Lead' then 'Lead to Drug Candidate', followed by 'Clinical Development', and finally 'Drug Manufacture'. The thirty one chapters cover a vast range of topics from analytical chemistry, including aspects involved in regulatory matters and in the prevention of fraud, to clinical imaging studies. Whilst this comprehensive volume will be essential reading for many scientists based in pharmaceutical and related industries, it should also be of considerable value to a much wider range of academic scientists whose research is related to the various aspects of pharmaceutical R&D; for them it will supply vital understanding of pharmaceutical industrial concerns and the basis of key decision making processes. About eMagRes Handbooks eMagRes (formerly the Encyclopedia of Magnetic Resonance) publishes a wide range of online articles on all aspects of magnetic resonance in physics, chemistry, biology and medicine. The existence of this large number of articles, written by experts in various fields, is enabling the publication of a series of eMagRes Handbooks on specific areas of NMR and MRI. The chapters of each of these handbooks will comprise a carefully chosen selection of eMagRes articles. In consultation with the eMagRes Editorial Board, the eMagRes handbooks are coherently planned in advance by specially-selected Editors, and new articles are written to give appropriate complete coverage. The handbooks are intended to be of value and interest to research students, postdoctoral fellows and other researchers learning about the scientific area in question and undertaking relevant experiments, whether in academia or industry. Have the content of this handbook and the complete content of eMagRes at your fingertips! Visit: www.wileyonlinelibrary.com/ref/eMagRes

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420081276
Language : En, Es, Fr & De

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Book Description :

The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy deter

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations Book
Author : Safaraz K. Niazi
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420081314
Language : En, Es, Fr & De

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Book Description :

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

Federal Register

Federal Register Book
Author : Anonim
Publisher : Unknown
Release : 1996-03-07
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

Long Acting Animal Health Drug Products

Long Acting Animal Health Drug Products Book
Author : Michael J. Rathbone,Arlene McDowell
Publisher : Springer Science & Business Media
Release : 2012-10-12
ISBN : 146144439X
Language : En, Es, Fr & De

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Book Description :

Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2007
ISBN : 9241209437
Language : En, Es, Fr & De

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Book Description :

This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.

Library Information Science Abstracts

Library   Information Science Abstracts Book
Author : Anonim
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Library Information Science Abstracts book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC Book
Author : Satinder Ahuja,Michael Dong
Publisher : Elsevier
Release : 2005-02-09
ISBN : 9780080455181
Language : En, Es, Fr & De

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Book Description :

High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Herbal Medicinal Products

Herbal Medicinal Products Book
Author : Frauke Gaedcke,Barbara Steinhoff,Helga Blasius
Publisher : Unknown
Release : 2003
ISBN : 9783887630980
Language : En, Es, Fr & De

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Book Description :

European legislation requires herbal medicinal products (HMPs) to meet strict standards of quality, safety and efficacy. In Europe and worldwide, HPMs play an important role both in self-medication and in medical practice. Book jacket.

Vaccine Analysis Strategies Principles and Control

Vaccine Analysis  Strategies  Principles  and Control Book
Author : Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin
Publisher : Springer
Release : 2014-11-27
ISBN : 3662450240
Language : En, Es, Fr & De

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Book Description :

This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.

Official Journal of the European Communities

Official Journal of the European Communities Book
Author : Anonim
Publisher : Unknown
Release : 1987
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Official Journal of the European Communities book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Particulate Products

Particulate Products Book
Author : Henk G. Merkus,Gabriel M.H. Meesters
Publisher : Springer Science & Business Media
Release : 2013-11-19
ISBN : 3319007149
Language : En, Es, Fr & De

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Book Description :

Particulate products make up around 80% of chemical products, from all industry sectors. Examples given in this book include the construction materials, fine ceramics and concrete; the delicacies, chocolate and ice cream; pharmaceutical, powders, medical inhalers and sun screen; liquid and powder paints. Size distribution and the shape of the particles provide for different functionalities in these products. Some functions are general, others specific. General functions are powder flow and require – at the typical particulate concentrations of these products – that the particles cause adequate rheological behavior during processing and/or for product performance. Therefore, this book addresses particle packing as well as its relation to powder flow and rheological behavior. Moreover, general relationships to particle size are discussed for e.g. color and sensorial aspects of particulate products. Product-specific functionalities are often relevant for comparable product groups. Particle size distribution and shape provide, for example, the following functionalities: - dense particle packing in relation to sufficient strength is required in concrete construction, ceramic objects and pharmaceutical tablets - good sensorial properties (mouthfeel) to chocolate and ice cream - effective dissolution, flow and compression properties for pharmaceutical powders - adequate hiding power and effective coloring of paints for protection and the desired esthetical appeal of the objects - adequate protection of our body against sun light by sunscreen - effective particle transport and deposition to desired locations for medical inhalers and powder paints. Adequate particle size distribution, shape and porosity of particulate products have to be achieved in order to reach optimum product performance. This requires adequate management of design and development as well as sufficient knowledge of the underlying principles of physics and chemistry. Moreover, flammability, explosivity and other health hazards from powders, during handling, are taken into account. This is necessary, since great risks may be involved. In all aspects, the most relevant parameters of the size distribution (and particle shape) have to be selected. In this book, experts in the different product fields have contributed to the product chapters. This provides optimum information on what particulate aspects are most relevant for behavior and performance within specified industrial products and how optimum results can be obtained. It differs from other books in the way that the critical aspects of different products are reported, so that similarities and differences can be identified. We trust that this approach will lead to improved optimization in design, development and quality of many particulate products.