Presents the basic elements of the science, & serves as an excellent introduction to this emerging field of photochemistry. Detailed experimental conditions for photostability studies are given, along with a discussion of the recently implemented ICH Guidelines for drug photostability.
An in-depth look at big pharma's flagship companyThe Merck Druggernaut takes readers inside Merck, the world's second most profitable drug company and maker of the world's bestselling drug, Prilosec. Consistently named one of Fortune magazine's Most Admired Companies, Merck struggles to maintain its reputation for being the most ethical of the big drug makers, refusing to slash research and development budgets in the face of declining profits, falling stock market prices, and questionable accounting. Author Fran Hawthorne, one of the leading journalists covering healthcare, has written an excellent examination of a business paragon with much-needed insight on the cutthroat world of pharmaceuticals. It's a story that will interest the business world as well as consumer and healthcare advocates by detailing the vital issues in medicine and healthcare today. More than just a compelling story of success in a difficult industry, more than simply the biography of one of big business's most recognizable names, The Merck Druggernaut takes a thoughtful look at some of the major issues of our time and the way those issues intertwine with the world of business.
Fran Hawthorne (New York, NY) is the Assistant Managing Editor at Crain's New York Business. She has been covering business for more than twenty years for such publications as Fortune, BusinessWeek, and Institutional Investor, with a prevailing interest in healthcare and pharmaceuticals. At Crain's, she spearheads the publication of two to three special healthcare issues per year.
Details the methods pharmaceutical companies employ to determine the safety profile of their drugs as well as surveys statistical procedures currently being used or developed to analyze, display, and compare laboratory data collected from controlled clinical trials.
Provides basic training in the whole analytical process for students, demonstrating why analysis is necessary and how to take samples, before they attempt to carry out any analysis in the laboratory.
This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability! Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery · includes a discussion of accelerated stability testing and its limitations in identifying stable formulations · details analytical methods commonly used in stability assessment and formulation development · stresses the importance of demonstrating the stability-indicating nature of an assay · describes the drug substance manufacturing process succinctly · examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration · covers aseptic processing in drug development and the potential development of a freeze-drying cycle · explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms · discusses the physical and chemical characteristics of proteins in microsphere delivery systems · analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation · explores formulations intended for injection, inhalation, and controlled delivery · and more! Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.
Two computer based educational modules were developed using the authoring package ToolBook Multimedia CBT Edition (Asymetrix Corporation), operating on a Windows® platform, and distributed on disk. They included tuition and assessment in the areas of pharmaceutical calculations (M1) and biopharmaceutics (M2) and were aimed at assisting overseas qualified pharmacists preparing for an Australian registration exam. Presented are the results of evaluations for the assessment programs' level of achievement of set educational objectives, frequency and patterns of use. Respondents (n=32) rated 'high-very high' the extent to which the following objectives were met: encouragement of testing of tutorial knowledge (M1: 90.3%; M2: 90.0%); provision of practice using the examination question format (M1: 90.0%; M2: 96.5%); encouragement of review of tutorials based on test performance (M1: 83.9%; M2: 86.7%). The analysis of data disks (n=58) on assessment program use indicated: total tests: (M1: 1,713; M2: 1,152); questions attempted: (M1: 20,900; M2: 15,921); timer option used: this was selected in 36.9% of total tests; period of testing with timer (118.4h) and without timer (598.1h) (maximum allowable question time recorded). Overall, the assessment programs were found very valuable components of each module. They were perceived to have met their set objectives and were significantly used.
Clinical researchers, with or without a statistical background, will find this book an invaluable aid in understanding the statistical methods cited most frequently in clinical protocols, statistical analysis plans, clinical and statistical reports, and medical journals. Written in a manner which leads the nonstatistician through each test by example, substantive details are presented which will benefit even the experienced data analysts. Introductory chapters provide elementary statistical concepts as applied to clinical trials and an overview of statistical inference, including discussions of power, sample size calculations, p-values and the logic behind hypothesis testing. Numerous examples from clinical research are worked through both manually and using SAS. Methods presented include t-tests, analysis of variance, repeated measures ANOVA, linear regression, analysis of covariance, non-parametric tests, binomial tests, chi-square test, Fisher's exact test, McNemar's test, Cochran-Mantel-Haenszel test, logistic regression, log-rank test, and Cox proportional hazards model. Supports releases 6.08 and higher of SAS software.
The B vitamins are eight water-soluble vitamins that play important roles in cell metabolism. Historically, the B vitamins were once thought to be a single vitamin, referred to as Vitamin B (much like how people refer to Vitamin C or Vitamin D). Later research showed that they are chemically distinct vitamins that often coexist in the same foods. Supplements containing all eight B vitamins are generally referred to as a vitamin B complex. Individual B vitamin supplements are referred to by the specific name of each vitamin (eg B1, B2, B3).The B vitamins often work together to deliver a number of health benefits to the body. B vitamins have been shown to: support and increase the rate of metabolism; maintain healthy skin and muscle tone; enhance immune and nervous system function; promote cell growth and division - including that of the red blood cells that help prevent anemia. Together, they also help combat the symptoms and causes of stress, depression, and cardiovascular disease. All B vitamins are water soluble, and are dispersed throughout the body. They must be replenished daily with any excess excreted in the urine. Vitamin B deficiency can lead to an enormous group of health problems. This book presents new and important research in the field.
In 1996, the Institute of Medicine launched the "Quality Chasm Series", a series of reports focused on assessing and improving the nation's quality of health care. "Preventing Medication Errors" is the newest volume in the series. Responding to the key messages in earlier volumes of the series - "To Err Is Human" (2000), "Crossing the Quality Chasm" (2001), and "Patient Safety" (2004) - this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. "Preventing Medication Errors" also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.
In 2001, FAO, WHO and the United Nations University (UNU) convened an Expert Consultation on Energy in Human Nutrition, which provided the most recent review of requirements and other energyrelated topics (FAO, 2004). As part of the preparatory process for both the Joint FAO/WHO/UNU Expert Consultation on Energy and that on Protein and Amino Acids in Human Nutrition five working groups were created and convened in June 2001 to deal with various topics that required a more thorough review than the others. Working Group 5 was devoted to Analytical Issues in Food Energy and Composition: Energy in Food Labelling, including Regulatory and Trade Issues (see Annex II), and was created partially in anticipation of possible changes in the energy requirements that may have resulted from the new requirements being based totally on energy expenditure data.2 In addition to discussing the preferred methods of protein, fat, carbohydrate and dietary fibre analysis, Working Group 5 also considered the following in its deliberations: 1) the routes of energy loss from the body such that the lost energy cannot contribute to maintaining energy balance; 2) the size of the energy loss for each of the energy-providing substrates, including fermentable carbohydrate; 3) variations in the energy losses reported in different studies of food components; 4) energy losses from normally consumed foods that have not previously been taken into account; and 5) factors external to food energy availability that modulate energy needs and the ability to maintain energy balance. Taking all of these into consideration, possible approaches to energy evaluation, including ways to account for diet-induced thermogenesis, were discussed. At about this time, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) requested FAO’s assistance in harmonizing energy conversion factors, and thus enabling uniformity in labelling and in the information provided to consumers (CCNFSDU, 2001a; 2002). This request was reinforced by the introduction of the information paper by the Australian delegation at the 23rd CCNGSDU session in 2001 (CCNFSDU, 2001b).
This book considers modern concepts of the chromatography of high-molecularweight compounds and its main theoretical and methodological features. Recommendations are given for the preparation of high-performance chromatographic systems and the choice of the optimum conditions for their operation. Particular attention is directed to the problems of the interpretation of chromatographic data with the aim of obtaining various molecular-weight and structural characteristics of the macromolecules investigated: AMW, MWD, indices of polymer branching, the compositional homogeneity of copolymers, the functionality of oligomers, etc. Examples are given of various combinations of chromatographic and other methods that can be used to analyse complex polymer systems. The applications of chromatography to the study of the process of association of the macromolecules and the determination of the porous structure of sorbents are demonstrated. The progress of modern chromatographic methods and the preparation of highly efficient sorbents and polymer standards is reviewed. The book is intended for research workers and technologists.
A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate.
The rapid progress in biology will continue to change the methodological approach to drug discovery in the coming years. Electronic media will continuously help researchers to access and share information. It is, however, becoming more and more evident that many young pharmacologists have only limited training in classical pharmacological methodologies. These long-standing and still highly relevant methods are simply not available in the electronic databases. Drug Discovery and Evaluation:Pharmacological Assays bridges this gap by comprehensively covering the pharmacological methods that have been utilized successfully for more than a hundred years as well as the latest technologies.The classical methods and the newest technologies, all in one book!
The 3rd edition of this successful reference book contains an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic, respiratory, renal, and immunomodulatory activities. Each of the more than 1000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. In addition, animal models of rare diseases are described.
For this third edition, all existing chapters have been revised and completely updated. A large number of assays were added: we are now publishing two volumes. Sections that have been specifically enlarged include - Pharmacological assays in thrombosis and haemostasis (formerly called activity of blood constituents), - Antidiabetic activity (includes completely new chapters such as Biochemical Methods in Diabetology), - Anti-atherosclerotic activity.
Lipospheres in Drug Targets and Delivery: Approaches, Methods, and Applications presents an overview of the most recent applications of lipospheres primarily in the field of medicine, pharmaceutics and biotechnology. Included are chapters on preparation, characterization, delivery (of peptides, proteins, vaccines, nucleic acids) therapeutic applications to different systems and suggestions for further research. Including numerous illustrations, tables and photos, this book provides procedures for specific applications and biological systems and shows lipospheres as a technical solution to various problems associated with controlled release of biochemicals.
Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.
These guidelines have been published to assist national laboratories and other relevant scientific institutions in obtaining, in a timely fashion, the reference standards that they require. They address some of the most frequently encountered difficulties.
Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a larege number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.