Download or read book Reviews in Pharmaceutical and Biomedical Analysis written by Paraskevas D. Tzanavaras and published by Bentham Science Publishers. This book was released on 2010 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Reviews in Pharmaceutical and Biomedical Analysis contains coverage and review of new trends and applications in all areas of pharmaceutical, biomedical and analytical chemistry. Authors have contributed review articles according to their expertise on var"
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Download or read book Pharmaceutical Analysis E Book written by David G. Watson and published by Elsevier Health Sciences. This book was released on 2015-12-24 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on Biotech products. New chapter on electrochemical methods in diagnostics. Greatly extended chapter on molecular emission spectroscopy to accommodate developments and innovations in the area. Now on StudentConsult
Download or read book Chemometrics based Spectroscopy for Pharmaceutical and Biomedical Analysis written by Hoang Vu Dang and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.
Download or read book Vibrational Spectroscopy Applications in Biomedical Pharmaceutical and Food Sciences written by Andrei A. Bunaciu and published by Elsevier. This book was released on 2020-07-26 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences synthesizes the latest research on the applications of vibrational spectroscopy in biomedical, pharmaceutical and food analysis. Suitable for graduate-level students as well as experienced researchers in academia and industry, this book is organized into five distinct sections. The first deals with the fundamentals of vibrational spectroscopy, with the second presenting the most important sampling methodology used for infrared and Raman spectroscopy in various fields of interest. Since spectroscopy is the study of the interaction of electromagnetic radiation with matter, this section deals with the characteristics, properties and absorption of electromagnetic radiation. Final sections describe the analytical studies performed all over the world in biomedical, pharmaceutical and in the food sciences. Presents a critical discussion of many of the applications of vibrational spectroscopy Covers details of the analytical methodologies used in pharmaceutical and biomedical applications Discusses the latest developments in pharmaceutical and biomedical analysis of both small and large molecules
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global consequences. By the best-selling author of Bad Science.
Download or read book Research in the Biomedical Sciences written by Michael Williams and published by Academic Press. This book was released on 2017-10-20 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research in the Biomedical Sciences: Transparent and Reproducible documents the widespread concerns related to reproducibility in biomedical research and provides a best practices guide to effective and transparent hypothesis generation, experimental design, reagent standardization (including validation and authentication), statistical analysis, and data reporting. The book addresses issues in the perceived value of the existing peer review process and calls for the need for improved transparency in data reporting. It reflects new guidelines for publication that include manuscript checklists, replication/reproducibility initiatives, and the potential consequences for the biomedical research community and societal health and well-being if training, mentoring, and funding of new generations of researchers and incentives for publications are not improved. This book offers real world examples, insights, and solutions to provide a thought-provoking and timely resource for all those learning about, or engaged in, performing and supervising research across the biomedical sciences. Provides a “big picture perspective on the scope of reproducibility issues and covers initiatives that have potential as effective solutions Offers real-world research context for transparent, reproducible experimental design, execution and reporting of biomedical research with the potential to address aspects of the translational gap in drug discovery Highlights the importance of reproducibility and the necessary changes in biomedical and pharmaceutical research training and incentives to ensure sustainability
Download or read book Novel Developments in Pharmaceutical and Biomedical Analysis written by Atta-ur- Rahman and published by Bentham Science Publishers. This book was released on 2018-04-24 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents information about a selection of analytical techniques. Readers will find information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. Novel Developments in Pharmaceutical and Biomedical Analysis is the second volume of the series and covers the following topics: o Chromatographic assays of solid dosage forms and their drug dissolution studies o UHPLC method for the estimation of bioactive compounds o HILIC based LC/MS for metabolite analysis o In vitro methods for the evaluation of oxidative stress o Application of vibrational spectroscopy in studies of structural polymorphism of drugs o Electrochemical sensors based on conductive polymers and carbon nanotubes o Optical sensor arrays for pharmaceutical and biomedical analyses o Chemical applications of ionic liquids o New trends in enantioanalysis of pharmaceutical compounds
Download or read book Spectroscopic Analyses written by Eram Sharmin and published by BoD – Books on Demand. This book was released on 2017-12-06 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book presents developments and applications of these methods, such as NMR, mass, and others, including their applications in pharmaceutical and biomedical analyses. The book is divided into two sections. The first section covers spectroscopic methods, their applications, and their significance as characterization tools; the second section is dedicated to the applications of spectrophotometric methods in pharmaceutical and biomedical analyses. This book would be useful for students, scholars, and scientists engaged in synthesis, analyses, and applications of materials/polymers.
Download or read book Analysis of Steroid Hormone Drugs written by S. Görög and published by Elsevier Science & Technology. This book was released on 1978 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Interpol s Forensic Science Review written by Niamh Nic Daeid and published by CRC Press. This book was released on 2017-08-09 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every three years, worldwide forensics experts gather at the Interpol Forensic Science Symposium to exchange ideas and discuss scientific advances in the field of forensic science and criminal justice. Drawn from contributions made at the latest gathering in Lyon, France, Interpol's Forensic Science Review is a one-source reference providing a comp
Download or read book Drug Abuse Handbook written by Steven B. Karch, MD, FFFLM and published by CRC Press. This book was released on 2019-07-17 with total page 1156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the handbook that professionals who deal with problems related to drugs and drug abuse have been waiting for. The impressive list of more than 80 contributors, each experts and leaders in their field, testifies to the importance of this outstanding new handbook. The volume contains detailed discussions of drug-related issues in criminalistics, pathology, and toxicology. Impairment testing and the pharmacokinetics of abused drugs are examined in detail, as is the field of workplace drug testing, the use of alternate testing matrices, drugs in sports, addiction medicine, and drug-related medical emergencies. The handbook focuses on the most urgent drug abuse-related problems of today An entire section is devoted to alcohol abuse, including a scientific appraisal of the most common drunk driving defenses, complete with sample calculations. Problems of postmortem toxicology are thoroughly detailed and an appendix lists key references for the most widely used analytic methods. An in-depth analysis of legal questions, including fetal rights and workplace testing Examination of the principles of addiction medicine and how doctors handle substance abuse problems A section addressing drug use by athletes, including a summary of current Olympic Committee Regulations regarding substance use and the latest information on detecting abuse of Human Growth Hormone and Erythropoietin Whether you are approaching the issue of drug abuse from a medical, psychological, toxicological, or legal perspective, the Drug Abuse Handbook is the most authoritative and complete resource available.
Download or read book Validation of Analytical Methods for Pharmaceutical Analysis written by Oona McPolin and published by Lulu.com. This book was released on 2009-05-01 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Download or read book Analysis of Pharmaceuticals by Capillary Electrophoresis written by Kevin D. Altria and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieser erste Titel einer ganzen Serie von anwendungsbezogenen Handbüchern zur Kapillarelektrophorese beschäftigt sich mit der Analytik von pharmazeutischen Substanzen. Dabei werden verschiedene Techniken praxisnah erläutert. Jeder, der im Labor - ob wissenschaftlich oder praxisnah - mit der Analyse von oft chiralen Pharmazeutika konfrontiert ist, wird viele Hinweise und Tips für seine Arbeit finden.USP: Einzige Monographie zur Analyse von Pharmazeutika mit CE This book describes the current state of the art for the analysis of pharmaceuticals by capillary electrophoresis and contains several hundred references to specific applications and methods. The main purpose of the book is to present the application possibilities of CE an therefore tabulated application data are provided. Chapters of the book are devoted to providing details of individual application areas such as chiral analysis, determination of drug related impurities, determination of drug counter-ions, drug residue monitoring and main component assay. An introductory chapter provides theoretical background to CE an related techniques. A chapter is dedicated to capillary electrochromatography which highlights the importance this technique currently possesses. Successful regulatory acceptance of CE methods is also described. A comprehensive chapter covers method validation aspects. Other chapters include discrete areas such as the use of non-aqueous solvents, forensic applications of CE, the application of experimental designs, determination of drugs in biofluids, and the analysis of vitamins by CE.
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
