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Quantitative and Qualitative Determination Technologies of Counterfeit Drugs

Author : Ronny Priefer

Publisher : CRC Press

Page : 192 pages

File Size : 20,3 MB

Release : 2023-08-10

Category : Medical

ISBN : 1000914011

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Book Description

Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and to propose options for controlling and reducing the prevalence of counterfeit medications. Various technologies are needed to identify the chemical properties of a questioned medicinal product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. Features Focuses on current technological approaches that are able to detect counterfeited pharmaceuticals Assesses the chemical methods of identifying counterfeit medicinal products and explains the theoretical underpinnings of the methods Provides case study type examples of the application for analysis of suspected counterfeit pharmaceuticals Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue The editor draws on his experience as a respected chemist and prolific author in the field to provide this unique text on drug counterfeiting detection



Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine

Publisher : National Academies Press

Page : 377 pages

File Size : 45,98 MB

Release : 2013-06-20

Category : Medical

ISBN : 0309269393

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Book Description

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.



Quantitative and Qualitative Determination Technologies on Counterfeit Drugs

Author : Ronny Priefer

Publisher :

Page : 0 pages

File Size : 26,28 MB

Release : 2023

Category :

ISBN : 9781032218984

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Book Description

"Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and propose options for controlling and reducing the prevalence of counterfeit medications. Different technologies are needed to identify the chemical properties of a questioned drug product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals"--



Quality Control and Evaluation of Herbal Drugs

Author : Pulok K. Mukherjee

Publisher : Elsevier

Page : 788 pages

File Size : 29,40 MB

Release : 2019-05-30

Category : Science

ISBN : 0128133988

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Book Description

Quality Control and Evaluation of Herbal Drugs brings together current thinking and practices for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development. Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs' activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development. - Provides new information on the research and development of natural remedies - essential reading on the study and use of natural resources for preventative or healing purposes - Brings together current thinking and practices in quality control and standardization of herbal drugs highlighting several integrated approaches for metabolomics, chemo-profiling and marker analysis - Aids in developing knowledge of various techniques including macroscopy, microscopy, HPTLC, HPLC, LC-MS/MS, GC-MS etc. with the development of integrated methods for evaluation of botanicals used in traditional medicine - Assessment of herbal drugs through bio-analytical techniques, bioassay guided isolation, enzyme inhibition, pharmacological, microbiological, antiviral assays and safety related quality issues - References global organizations, such as the WHO, USFDA, CDSCO, AYUSH, TCM and others to serve as a comprehensive document for enforcement agencies, NGOs and regulatory authorities



Portable Spectroscopy and Spectrometry, Applications

Author : Richard A. Crocombe

Publisher : John Wiley & Sons

Page : 608 pages

File Size : 35,80 MB

Release : 2021-04-28

Category : Science

ISBN : 1119636434

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Book Description

The most comprehensive resource available on the many applications of portable spectrometers, including material not found in any other published work Portable Spectroscopy and Spectrometry: Volume Two is an authoritative and up-to-date compendium of the diverse applications for portable spectrometers across numerous disciplines. Whereas Volume One focuses on the specific technologies of the portable spectrometers themselves, Volume Two explores the use of portable instruments in wide range of fields, including pharmaceutical development, clinical research, food analysis, forensic science, geology, astrobiology, cultural heritage and archaeology. Volume Two features contributions by a multidisciplinary team of experts with hands-on experience using portable instruments in their respective areas of expertise. Organized both by instrumentation type and by scientific or technical discipline, 21 detailed chapters cover various applications of portable ion mobility spectrometry (IMS), infrared and near-infrared (NIR) spectroscopy, Raman and x-ray fluorescence (XRF) spectroscopy, smartphone spectroscopy, and many others. Filling a significant gap in literature on the subject, the second volume of Portable Spectroscopy and Spectrometry: Features a significant amount of content published for the first time, or not available in existing literature Brings together work by authors with assorted backgrounds and fields of study Discusses the central role of applications in portable instrument development Covers the algorithms, calibrations, and libraries that are of critical importance to successful applications of portable instruments Includes chapters on portable spectroscopy applications in areas such as the military, agriculture and feed, hazardous materials (HazMat), art conservation, and environmental science Portable Spectroscopy and Spectrometry: Volume Two is an indispensable resource for developers of portable instruments in universities, research institutes, instrument companies, civilian and government purchasers, trainers, operators of portable instruments, and educators and students in portable spectroscopy courses.



Analytical Techniques in the Pharmaceutical Sciences

Author : Anette Müllertz

Publisher : Springer

Page : 829 pages

File Size : 11,66 MB

Release : 2016-08-30

Category : Medical

ISBN : 1493940295

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Book Description

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.



Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine

Publisher : National Academies Press

Page : 483 pages

File Size : 26,43 MB

Release : 2017-09-28

Category : Medical

ISBN : 0309459575

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Book Description

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.



Trade in Counterfeit and Pirated Goods

Author : Piotr Stryszowski

Publisher :

Page : 130 pages

File Size : 27,10 MB

Release : 2016

Category :

ISBN : 9789291562060

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Book Description

This study offers unique up-to-date analysis of the impact on global trade of counterfeit and pirated products, known as "fakes" by the general public. Using statistical analysis and drawing on a global dataset covering almost half million customs data on seizures, the study estimates the huge share of international trade commandeered by counterfeit and pirated goods. In 2013, international trade in such products represented up to 2.5% of world trade, or as much as USD 461 billion. This is the equivalent of the GDP of Austria, or the combined GDP of Ireland and the Czech Republic. Above all, it highlights that right holders, governments and the formal economy as a whole suffer from significant economic and social losses. It also gives an idea about the potential financial revenues collected by criminal networks that are behind such trade.^More specifically, counterfeit and pirated products amounted to up to 5 % of imports in 2013 in the European Union, or as much as EUR 85 billion (USD 116 billion). This suggests that the relative impact of counterfeiting is twice as high for a group of developed countries, such as the EU, than it is for the world as a whole. The scope of the phenomenon appears to be greater than a decade ago. Back in 2008, a previous OECD study estimated that counterfeit and pirated goods accounted for up to 1.9 % of world imports, or up to USD 200 billion, relying on the best data and more limited methods available at that time. In the context of today's revival of international trade in the global economy, there is no shortage of opportunities for counterfeiters and criminals. Counterfeit and pirated trade is a major threat to any modern, knowledge-based economy. Counterfeiting and piracy matter in an innovation driven global economy.^Intellectual property (IP) is a key value generator for firms, helping them succeed in competitive markets. At the macroeconomic level, IP protection and enforcement is one of the main drivers of innovation, which contributes to long term economic growth. Given the fundamental economic importance of IP, counterfeiting and piracy must be directly targeted as a threat to sustainable IP-based business models.



Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Author : World Intellectual Property Organization

Publisher : WIPO

Page : 259 pages

File Size : 12,14 MB

Release : 2013

Category : Law

ISBN : 9280523082

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Book Description

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.



Essentials of Herbal Drug Technology

Author : Shanti Bhushan Mishra

Publisher : Educreation Publishing

Page : 320 pages

File Size : 37,97 MB

Release : 2019-01-30

Category : Education

ISBN :

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Book Description

Essentials of Herbal Drug Technology is a unique attempt to arouse the interest of students in this fast developing branch of pharmacy i.e. Pharmacognosy and related fields like herbal medicine, natural products and their standardization because increasing interest in the field of herbal medicine and ayurvedic dosage forms; their standardization is utmost required. The Book provides in depth information about various guidelines of different regulatory bodies that are required in quality control of herbal drugs. This book has been written with the object that the new syllabus of the Bachelor in Pharmacy, Master in Pharmacy and doctorate in herbal medicines and their pharmacological efficacy as per PCI course curriculum is covered in reasonable detail to provide sound scientific knowledge of quality control and standardization.