This book is a self-contained introduction to Statistics, presented in the context of clinical trials and pharmaceutical drug development. It focuses on the statistical analyses most commonly used in drug development and is therefore an ideal introduction to pharmaceutical statistics. Instead of introducing a series of statistical techniques, the book's organizational structure follows the order in which numerical information and statistical analyses are used in trials and new drug development.All students taking classes in pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application and importance of Statistics. They need to understand:why, and how data are collected in clinical trials; how these data are summarized and analyzed; what the results mean in the context of the clinical research question; and, how the results are communicated to regulatory agencies and to scientific and medical communities.This title therefore adopts a unique approach and concept in organization of the content. It begins with an introduction to statistical theory, analysis and interpretation. This is followed by a discussion of t-tests and confidence intervals. Readers are then taken through the whole process of new drug development (using one specific example throughout) that is meaningful in the context of their broader studies. Throughout this process, statistical techniques and analyses are introduced in the order in which they are employed during the process.The book's realistic scientific and progressive organization from pre-clinical trials to clinical pharmacology through clinical trials is novel, meaningful and educationally powerful. The book emphasises the importance of descriptive statistics as well as inferential statistics, something that is rarely done.Supplementary material is included for this text on the PharmPress website in the form of PowerPoint lecture notes on Statistics (based on content of this book) that can be downloaded by lecturers.
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.
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).
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.
Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
Pharmacoeconomics is a new word but decisions about which treatments are available within any health care system have always been influenced by the availability of resources. Today, the economics of care and treatment are major issues for governments and health services throughout the world. This is the first text to provide an authoritative economic evaluation of the use of drugs in psychiatry. The authors have reviewed the world literature on the subject and include all the most recent data. The book provides pragmatic but scientifically robust reviews of the pharmacoeconomic aspects of drug prescribing in order to improve clinical practice. With the ultimate aim of ensuring that resources are used to the best effect and thus improve the health and quality of life of people with mental health problems, this practical handbook is an important text for psychiatrists and GPs, as well as for health service providers and managers.
Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.
Hardbound. In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.Features of this book:
• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry
• Illustrates the different approaches available to attain robustness
Accurately calculating medication dosages is a critical element in pharmaceutical care that directly effects optimal patient outcomes. Unfortunately, medication dosage errors happen in pharmacies, in hospitals, or even at home or in homecare settings everyday. In extreme cases, even minor dosage errors can have dire consequences. Careful calculations are essential to providing optimal medical and pharmaceutical care. Essential Math and Calculations for Pharmacy Technicians fills the need for a basic reference that students and professionals can use to help them understand and perform accurate calculations. Organized in a natural progression from the basic to the complex, the book includes:·Roman and Arabic Numerals·Fractions and decimals·Ratios, proportions, and percentages·Systems of measurement including household conversions·Interpretation of medication orders·Isotonicity, pH, buffers, and reconstitutions·Intravenous flow rates·Insulin and Heparin products·Pediatric dosage·Business mathPacked with numerous solved examples and practice problems, the book presents the math in a step-by-step style that allows readers to quickly grasp concepts. The authors explain the fundamentals simply and clearly and include ample practice problems that help readers become proficient. The focus on critical thinking, real-life problem scenarios, and the self-test format make Essential Math and Calculations for Pharmacy Technicians an indispensable learning tool.
This extremely pragmatic and accessible reference provides scientists with a basic knowledge of statistics, focusing on the practical application of statistical methods to research, quality control, and data analysis. Basic Statistics and Pharmaceutical Statistical Applications explores types of variables, random sampling, probability, measures of central tendency, and hypothesis testing, discusses regression analysis, nonparametric tests, and power determination, and examines study designs, confidence intervals, dissolution testing, and bioequivalence. Also described are the interrelation of hypotheses, test statistics, decision rules, computations, statistical decisions and testing factors.
This book is a friendly jargon buster, which aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence. The audience for the book includes physicians, statisticians, pharmacists, medical students, clinical researchers, medical writers, data managers, study co-ordinators, pharmaceutical sales representatives, and financial (medical) analysts.
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.