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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :362
  • ISBN : 9781908818638
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Summary : Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2015-10-09
  • Total pages :316
  • ISBN : 9780081000441
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Summary : Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2020-09-02
  • Total pages :976
  • ISBN : 9780128144558
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Summary : The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2018-11-30
  • Total pages :374
  • ISBN : 9780128149126
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Summary : Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Hugo and Russell's Pharmaceutical Microbiology

Hugo and Russell's Pharmaceutical Microbiology
  • Author : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman
  • Publisher :Unknown
  • Release Date :2008-04-15
  • Total pages :496
  • ISBN : 9781405141031
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Summary : Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher :Unknown
  • Release Date :2020-01-02
  • Total pages :592
  • ISBN : 9781119356073
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Summary : Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Handbook of Hygiene Control in the Food Industry

Handbook of Hygiene Control in the Food Industry
  • Author : H. L. M. Lelieveld,John Holah,Domagoj Gabric
  • Publisher :Unknown
  • Release Date :2016-06-10
  • Total pages :756
  • ISBN : 9780081001974
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Summary : Handbook of Hygiene Control in the Food Industry, Second Edition, continues to be an authoritative reference for anyone who needs hands-on practical information to improve best practices in food safety and quality. The book is written by leaders in the field who understand the complex issues of control surrounding food industry design, operations, and processes, contamination management methods, route analysis processing, allergenic residues, pest management, and more. Professionals and students will find a comprehensive account of risk analysis and management solutions they can use to minimize risks and hazards plus tactics and best practices for creating a safe food supply, farm to fork. Presents the latest research and development in the field of hygiene, offering a broad range of the microbiological risks associated with food processing Provides practical hygiene related solutions in food facilities to minimize foodborne pathogens and decrease the occurrence of foodborne disease Includes the latest information on biofilm formation and detection for prevention and control of pathogens as well as pathogen resistance

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms
  • Author : Dr. Tim Sandle
  • Publisher :Unknown
  • Release Date :2012-08-02
  • Total pages :300
  • ISBN : 9781781480809
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Summary : The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.

Dosage Form Design Parameters

Dosage Form Design Parameters
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2018-07-25
  • Total pages :810
  • ISBN : 9780128144220
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Summary : Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Quality Assurance

Quality Assurance
  • Author : G Welty
  • Publisher :Unknown
  • Release Date :2013-06-30
  • Total pages :374
  • ISBN : 9781908818621
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Summary : Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. Presents a comprehensive view of the field of quality assurance An approach grounded in direct experience Uses diagrams and figures to clarify analytical points

Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems

Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems
  • Author : Kevin L. Williams
  • Publisher :Unknown
  • Release Date :2019-07-24
  • Total pages :869
  • ISBN : 9783030171483
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Summary : Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd “living fossil” (Limulus). It is used to detect remnants of the most primitive and destructive forms of life (prokaryotes) as contaminants of complex modern systems (mammalian and Pharma). Recent challenges in the field include those associated with the application of traditional methods to new types of molecules and manufacturing processes. The advent of “at will” production of biologics in lieu of harvesting animal proteins has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are widely acknowledged, the realization of the differences in the means of production and changes in the manner of control of potential impurities and contaminants in regard to the new versus the old are less widely appreciated. Endotoxin as an ancient, dynamic interface between lifeforms, provides a singular perspective from which to view the parallel development of ancient and modern organisms as well as the progress of man in deciphering the complexity of their interactions in his efforts to overcome disease.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher :Unknown
  • Release Date :2007-09-25
  • Total pages :760
  • ISBN : 1420019791
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Summary : Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
  • Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
  • Publisher :Unknown
  • Release Date :2003-09-02
  • Total pages :280
  • ISBN : 0203305191
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Summary : Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation & Sterilization

Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation & Sterilization
  • Author : Adam P. Fraise,Peter A. Lambert,Jean-Yves Maillard
  • Publisher :Unknown
  • Release Date :2008-04-15
  • Total pages :688
  • ISBN : 9780470755068
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Summary : Highly respected, established text – a definitive reference in its field – covering in detail many methods of the elimination or prevention of microbial growth "highly recommended to hospital and research personnel, especially to clinical microbiologists, infectioncontrol and environmental-safety specialists, pharmacists, and dieticians." New England Journal of Medicine WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace of change in this area Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Gives practical advise on problems of disinfection and antiseptics in hospitals Discusses increasing problems of natural and acquired resistance to antibiotics New contributors give a fresh approach to the subject and ensure international coverage Systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action

Bioinformatics for Biomedical Science and Clinical Applications

Bioinformatics for Biomedical Science and Clinical Applications
  • Author : K-H Liang
  • Publisher :Unknown
  • Release Date :2013-07-31
  • Total pages :170
  • ISBN : 9781908818232
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Summary : Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions. The first two chapters consider Bioinformatics and analysis of the human genome. The subsequent three chapters cover the introduction of Transcriptomics, Proteomics and Systems biomedical science. The remaining chapters move on to critical developments, clinical information and conclude with domain knowledge and adaptivity. A coherent presentation of concepts, methodologies and practical tools that systematically lead to significant discoveries in the biomedical and clinical area Real examples of cutting edge discoveries The introduction of study types and technologies for all the DNA, RNA and protein levels

Marine Enzymes for Biocatalysis

Marine Enzymes for Biocatalysis
  • Author : Antonio Trincone
  • Publisher :Unknown
  • Release Date :2013-09-30
  • Total pages :576
  • ISBN : 9781908818355
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Summary : Marine bioprospecting is a highly topical subject - in both applied and basic research - but, as yet, the marine ecosystem is a relatively unexplored source of natural bioactive substances with potential therapeutic activity. This book addresses the use of marine enzymes in biocatalysis through a series of chapters from leading scientists within academic and industrial fields. Biocatalytic processes can take advantage of the habitat-related properties of marine enzymes, such as salt tolerance, hyperthermostability, barophilicity, cold adaptivity, and so on, whilst also taking into consideration substrate specificity and affinity. These evolved properties are linked to the metabolic functions of the enzymes and to the ecological aspects of the natural source. New properties can also be discovered at the molecular level of catalysis, particularly concerning the stereochemical characteristics of products. Marine enzymes for biocatalysis initially examines the nature and level of interest in marine biological diversity, and outlines the fundamentals of biocatalysis. It goes on to detail sources of marine enzymes, and to analyse examples from both chemical and stereochemical viewpoints of catalysis, including microbial enzymes and animal or plant sources. The book goes on to explore the future potential of marine bioprospecting in biocatalysis. Compiles studies from leading scientists in a direct and accessible format. Includes practical descriptions of results, adding further details not often covered in formal articles Takes a molecular view which fully explains the enzymatic aspects of reactions, particularly regarding biocatalytic characteristics and descriptions of bioprocesses Selects examples of chemical and stereochemical aspects of enzymatic action with respect to known terrestrial counterparts

Ocular Transporters and Receptors

Ocular Transporters and Receptors
  • Author : Ashim K Mitra
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :276
  • ISBN : 9781908818317
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Summary : Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this book the cutting edge research being carried out in this field is compiled and summarized. The book focuses on key areas, including the anatomy and physiology of the eye, biology of ocular transporters and receptors, techniques in characterization of transporters and receptors, transporters and receptors in the anterior and posterior segment in the eye, the role of ocular transporters and receptors in drug delivery, and transporter-metabolism interplay in the eye. Highly focused on ocular transporters Most up-to-date research compilation Detailed description of role of transporters and receptors in ocular drug discovery and delivery

Lean Biomanufacturing

Lean Biomanufacturing
  • Author : Nigel J Smart
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :384
  • ISBN : 9781908818409
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Summary : With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher :Unknown
  • Release Date :2014-08-22
  • Total pages :780
  • ISBN : 9781908818287
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Summary : Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery and developments. A comprehensive overview of drug transporter families and their clinical relevance in drug discovery and development Balanced coverage of molecular biology aspects and functional outcomes State of art knowledge related to transporter-mediated DDI and the clinical relevance in pharmacokinetics, dynamics, and toxicity

Drug-Biomembrane Interaction Studies

Drug-Biomembrane Interaction Studies
  • Author : Rosario Pignatello
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :440
  • ISBN : 9781908818348
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Summary : The design and development of drugs and new pharmaceutical formulations require a full characterization of the chemical and physicochemical events occurring at the level of the single active ingredients or excipients, as well as their reciprocal interaction. Thermal analysis techniques are among the most widely used methods to achieve this; among them, the Differential Scanning Calorimetry (DSC) technique, in which the thermotropic behaviour of a single substance or mixtures is analyzed as a function of a controlled temperature program. DSC is an accurate and rapid thermo-analytical technique, widely used by the pharmaceutical industry and in drug research to investigate several physico-chemical phenomena, such as polymorphism, melting and crystallization, purity, and drug-excipient interaction; as well as characterizing biomolecules such as genetic material. Drug-biomembrane interaction studies is written by scientists renowned for their work in the field of DSC applications to drug development and delivery, and especially to drug-biomembrane interaction studies. The book combines insights from biochemistry and physiology with those from structural biology, nanotechnology and biothermodynamics, to obtain a complete depiction of cell membranes and their functions. Summarizes and updates the recent development in a unique handbook format Consists of a combination of scientific updates within the field Contains chapters written by some of the highest-level experts in the field of DSC

Orphan Drugs

Orphan Drugs
  • Author : Elizabeth Hernberg-Ståhl,Miroslav Reljanović
  • Publisher :Unknown
  • Release Date :2013-11-15
  • Total pages :334
  • ISBN : 9781908818393
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Summary : This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups. The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey. After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs. The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs. A comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patients A source of updated information, news and trends for those who are already active in this fast-evolving field Covers the global definitions and the criteria for getting an orphan drug designation in, for example, the US and Europe