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Hplc Method Development For Pharmaceuticals

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HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals Book
Author : Satinder Ahuja,Henrik Rasmussen
Publisher : Elsevier
Release : 2011-09-21
ISBN : 0080554199
Language : En, Es, Fr & De

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Book Description :

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

HPLC Method Development and Validation in Pharmaceutical Analysis

HPLC Method Development and Validation in Pharmaceutical Analysis Book
Author : Ghulam Shabir
Publisher : LAP Lambert Academic Publishing
Release : 2013-01
ISBN : 9783659321207
Language : En, Es, Fr & De

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Book Description :

This handbook is concerned with new chromatographic method development and validation using novel systematic approaches for pharmaceutical compounds. The first stage of the research was to study how method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners in the pharmaceutical industry. Furthermore, it was recognised that this protocol should satisfy the requirements of the major regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC, LC-MS and GC. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of single guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

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

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations HPLC And HPTLC Techniques

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations  HPLC And HPTLC Techniques Book
Author : Satish Y. Gabhe
Publisher : diplom.de
Release : 2015-08-01
ISBN : 3954898071
Language : En, Es, Fr & De

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Book Description :

This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists Book
Author : Yuri V. Kazakevich,Rosario LoBrutto
Publisher : John Wiley & Sons
Release : 2007-02-16
ISBN : 0470087943
Language : En, Es, Fr & De

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Book Description :

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Analytical Method Development and Validation

Analytical Method Development and Validation Book
Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Release : 2018-10-03
ISBN : 1482229773
Language : En, Es, Fr & De

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Book Description :

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Development of Novel Stability Indicating Methods Using Liquid Chromatography

Development of Novel Stability Indicating Methods Using Liquid Chromatography Book
Author : Mukesh Maithani,Parveen Bansal
Publisher : Springer
Release : 2019-08-07
ISBN : 9811387230
Language : En, Es, Fr & De

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Book Description :

Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a ‘how-to guide’ to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.

An Introduction to HPLC for Pharmaceutical Analysis

An Introduction to HPLC for Pharmaceutical Analysis Book
Author : Oona McPolin
Publisher : Lulu.com
Release : 2009-03-01
ISBN : 0956152805
Language : En, Es, Fr & De

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Book Description :

If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.

Hplc Method Development For Pharmaceuticals Vol 8 Hb

Hplc Method Development For Pharmaceuticals  Vol  8  Hb  Book
Author : Ahuja
Publisher : Unknown
Release : 2009-01-01
ISBN : 9788131219355
Language : En, Es, Fr & De

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Book Description :

Download Hplc Method Development For Pharmaceuticals Vol 8 Hb book written by Ahuja, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Supercritical Fluid Chromatography

Supercritical Fluid Chromatography Book
Author : Gregory K. Webster
Publisher : CRC Press
Release : 2014-02-04
ISBN : 9814463000
Language : En, Es, Fr & De

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Book Description :

Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges of today’s pharmaceutical industry. One technique that has made steady advances in pharmaceutical analysis is supercritical fluid chromatography (SFC). SFC is meeting the chromatography needs of the industry by providing efficient and selective testing capabilities on the analytical and preparative scale. The supercritical fluid mobile phase, consisting mainly of CO2, facilitates cost reduction costs and helps the industry in meeting green chemistry standards. This book provides a comprehensive overview of the use of SFC in pharmaceutical analysis. Supercritical Fluid Chromatography reviews the use of SFC in drug-discovery applications and describes its application in drug development. When a drug is developed and brought to market, it is tested many times for impurities and degradants, enantiomeric purity, and analytical and preparative isolations—it is tested during discovery and development and for under-regulated and unregulated methodologies. The book describes the use of SFC for each of these applications and discusses more in-depth topics, such as the use of SFC in mass spectrometric and polarographic detection. The book also sheds light on the role of SFC in drug development from natural products and the advancement of SFC with new technologies and its use in pilot-scale operations as a chromatographic technique.

Modern HPLC for Practicing Scientists

Modern HPLC for Practicing Scientists Book
Author : Michael W. Dong
Publisher : John Wiley & Sons
Release : 2016-04-06
ISBN : 111929360X
Language : En, Es, Fr & De

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Book Description :

A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.

HPLC and UHPLC for Practicing Scientists

HPLC and UHPLC for Practicing Scientists Book
Author : Michael W. Dong
Publisher : John Wiley & Sons
Release : 2019-07-23
ISBN : 1119313767
Language : En, Es, Fr & De

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Book Description :

A concise yet comprehensive reference guide on HPLC/UHPLC that focuses on its fundamentals, latest developments, and best practices in the pharmaceutical and biotechnology industries Written for practitioners by an expert practitioner, this new edition of HPLC and UHPLC for Practicing Scientists adds numerous updates to its coverage of high-performance liquid chromatography, including comprehensive information on UHPLC (ultra-high-pressure liquid chromatography) and the continuing migration of HPLC to UHPLC, the modern standard platform. In addition to introducing readers to HPLC’s fundamentals, applications, and developments, the book describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. HPLC and UHPLC for Practicing Scientists, Second Edition offers three new chapters. One is a standalone chapter on UHPLC, covering concepts, benefits, practices, and potential issues. Another examines liquid chromatography/mass spectrometry (LC/MS). The third reviews at the analysis of recombinant biologics, particularly monoclonal antibodies (mAbs), used as therapeutics. While all chapters are revised in the new edition, five chapters are essentially rewritten (HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects). The book also includes problem and answer sections at the end of each chapter. Overviews fundamentals of HPLC to UHPLC, including theories, columns, and instruments with an abundance of tables, figures, and key references Features brand new chapters on UHPLC, LC/MS, and analysis of recombinant biologics Presents updated information on the best practices in method development, validation, operation, troubleshooting, and maintaining regulatory compliance for both HPLC and UHPLC Contains major revisions to all chapters of the first edition and substantial rewrites of chapters on HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects Includes end-of-chapter quizzes as assessment and learning aids Offers a reference guide to graduate students and practicing scientists in pharmaceutical, biotechnology, and other industries Filled with intuitive explanations, case studies, and clear figures, HPLC and UHPLC for Practicing Scientists, Second Edition is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology. It will be a great benefit to every busy laboratory analyst and researcher.

Practical Hplc and Lc Ms Method Development and Validation

Practical Hplc and Lc Ms Method Development and Validation Book
Author : Ghulam A. Shabir
Publisher : LAP Lambert Academic Publishing
Release : 2012-06
ISBN : 9783659123528
Language : En, Es, Fr & De

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Book Description :

The coherent body of research described in this book is concerned with new HPLC method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC and LC-MS. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Software assisted Method Development In High Performance Liquid Chromatography

Software assisted Method Development In High Performance Liquid Chromatography Book
Author : Szabolcs Fekete,Imre Molnar
Publisher : World Scientific
Release : 2018-08-01
ISBN : 1786345471
Language : En, Es, Fr & De

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Book Description :

'The book is a useful contribution in the field of HPLC, and may represent a valuable tool for chromatography practitioners in different fields, as well as teachers and instructors. The 12 chapters provide comprehensive insights of current day retention and resolution modelling in HPLC, and its applications for small and large molecule analysis. It may be a useful reference for specialists in pharmaceuticals but not limited to … It may be a valuable resource to assist scientists involved in method development, aiming to achieve the best results with reduced costs, time, and efforts.'Analytical and Bioanalytical ChemistryThis handbook gives a general overview of the possibilities in recent developments in chromatographic retention modeling. As a result of the latest developments in modeling software, several new features are now accessible, opening a new level in HPLC method development.Many of these current possibilities in software assisted liquid chromatographic method modeling for analytical purposes are presented. Several modes of chromatography, including Reversed-Phase Liquid Chromatography (RPLC), Ion Exchange Chromatography (IEX), Hydrophobic Interaction Chromatography (HIC), and Hydrophilic Interaction Liquid Chromatography (HILIC) are explained in detail. For all these chromatographic modes, the most important variables for tuning retention and selectivity are exposed.Beside the industrial and practical benefits of retention modeling, the possibilities in teaching and education are also illustrated. Finally, numerous representative industrial examples are shown, to highlight the benefits, time and cost savings offered by state-of-the-art software assisted HPLC method development.

Analysis and Analyzers

Analysis and Analyzers Book
Author : Béla G. Lipták,Kriszta Venczel
Publisher : CRC Press
Release : 2016-11-25
ISBN : 1498727697
Language : En, Es, Fr & De

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Book Description :

The Instrument and Automation Engineers’ Handbook (IAEH) is the #1 process automation handbook in the world. Volume two of the Fifth Edition, Analysis and Analyzers, describes the measurement of such analytical properties as composition. Analysis and Analyzers is an invaluable resource that describes the availability, features, capabilities, and selection of analyzers used for determining the quality and compositions of liquid, gas, and solid products in many processing industries. It is the first time that a separate volume is devoted to analyzers in the IAEH. This is because, by converting the handbook into an international one, the coverage of analyzers has almost doubled since the last edition. Analysis and Analyzers: Discusses the advantages and disadvantages of various process analyzer designs Offers application- and method-specific guidance for choosing the best analyzer Provides tables of analyzer capabilities and other practical information at a glance Contains detailed descriptions of domestic and overseas products, their features, capabilities, and suppliers, including suppliers’ web addresses Complete with 82 alphabetized chapters and a thorough index for quick access to specific information, Analysis and Analyzers is a must-have reference for instrument and automation engineers working in the chemical, oil/gas, pharmaceutical, pollution, energy, plastics, paper, wastewater, food, etc. industries. About the eBook The most important new feature of the IAEH, Fifth Edition is its availability as an eBook. The eBook provides the same content as the print edition, with the addition of thousands of web addresses so that readers can reach suppliers or reference books and articles on the hundreds of topics covered in the handbook. This feature includes a complete bidders' list that allows readers to issue their specifications for competitive bids from any or all potential product suppliers.

Evidence Based Validation of Traditional Medicines

Evidence Based Validation of Traditional Medicines Book
Author : Subhash C. Mandal
Publisher : Springer Nature
Release : 2020
ISBN : 9811581274
Language : En, Es, Fr & De

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Book Description :

Download Evidence Based Validation of Traditional Medicines book written by Subhash C. Mandal, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Prof of Drug Substances Excipients and Related Methodology

Prof  of Drug Substances  Excipients and Related Methodology Book
Author : Abdulrahman Al-Majed
Publisher : Academic Press
Release : 2021-01-16
ISBN : 0128241284
Language : En, Es, Fr & De

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Book Description :

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 46 contains comprehensive profiles of five drug compounds: Darunavir, Bisoprolol, Betaxolol, Rabeprazole and Irbesartan. In addition, the work contains a chapter reviewing Bioassay Methods and Their Applications in Herbal Drug Research. The comprehensive reviews in the book cover all aspects of drug development and the formulation of drugs, helping readers understand how the drug development community remains essential to all phases of pharmaceutical development. In addition, this work answers why such profiles are of immeasurable importance to workers in the field. The scope of the Profiles series encompasses review articles and database compilations that fall within one or more of the following five broad categories: Physical Profiles of Drug Substances and Excipients, Analytical Profiles of Drug Substances and Excipients, ADME Profiles of Drug Substances and Excipients, Methodology Related to the Characterization of Drug Substances and Excipients, and Methods of Chemical Synthesis. Contains contributions from leading authorities Presents an excellent overview on the physical, chemical and biomedical properties of some regularly prescribed drugs Includes a cumulative index in each volume

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development Book
Author : Kangping Xiao
Publisher : John Wiley & Sons
Release : 2020-10-06
ISBN : 1119547857
Language : En, Es, Fr & De

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Book Description :

This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

Profiles of Drug Substances Excipients and Related Methodology

Profiles of Drug Substances  Excipients  and Related Methodology Book
Author : Anonim
Publisher : Academic Press
Release : 2017-04-19
ISBN : 0128122277
Language : En, Es, Fr & De

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Book Description :

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic. This latest release covers a variety of substances, including Cinacalcet Hydrochloride, Clenbuterol Hydrochloride, Gliclazide, Lomefloxacin, Olmesartan, Propranolol, and Tolterodine Tartrate. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories, Physical profiles of drug substances and excipients, Analytical profiles of drug substances and excipients, Drug metabolism and pharmacokinetic profiles of drug substances and excipients, Methodology related to the characterization of drug substances and excipients, Methods of chemical synthesis, and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. Contains contributions from leading authorities Informs and updates on all the latest developments in the field

Nanoscale Fabrication Optimization Scale up and Biological Aspects of Pharmaceutical Nanotechnology

Nanoscale Fabrication  Optimization  Scale up and Biological Aspects of Pharmaceutical Nanotechnology Book
Author : Alexandru Mihai Grumezescu
Publisher : William Andrew
Release : 2017-12-11
ISBN : 0128136308
Language : En, Es, Fr & De

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Book Description :

Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry