Author: James E. De Muth
Publisher: Springer Nature
ISBN: 3030339890
Category : Medical
Languages : en
Pages : 257
Get Book Here
Book Description
This is an introductory statistics book designed to provide scientists with practical information needed to apply the most common statistical tests to laboratory research data. The book is designed to be practical and applicable, so only minimal information is devoted to theory or equations. Emphasis is placed on the underlying principles for effective data analysis and survey the statistical tests. It is of special value for scientists who have access to Minitab software. Examples are provides for all the statistical tests and explanation of the interpretation of these results presented with Minitab (similar to results for any common software package). The book is specifically designed to contribute to the AAPS series on advances in the pharmaceutical sciences. It benefits professional scientists or graduate students who have not had a formal statistics class, who had bad experiences in such classes, or who just fear/don’t understand statistics. Chapter 1 focuses on terminology and essential elements of statistical testing. Statistics is often complicated by synonyms and this chapter established the terms used in the book and how rudiments interact to create statistical tests. Chapter 2 discussed descriptive statistics that are used to organize and summarize sample results. Chapter 3 discussed basic assumptions of probability, characteristics of a normal distribution, alternative approaches for non-normal distributions and introduces the topic of making inferences about a larger population based on a small sample from that population. Chapter 4 discussed hypothesis testing where computer output is interpreted and decisions are made regarding statistical significance. This chapter also deasl with the determination of appropriate sample sizes. The next three chapters focus on tests that make decisions about a population base on a small subset of information. Chapter 5 looks at statistical tests that evaluate where a significant difference exists. In Chapter 6 the tests try to determine the extent and importance of relationships. In contrast to fifth chapter, Chapter 7 presents tests that evaluate the equivalence, not the difference between levels being tested. The last chapter deals with potential outlier or aberrant values and how to statistically determine if they should be removed from the sample data. Each statistical test presented includes an example problem with the resultant software output and how to interpret the results. Minimal time is spent on the mathematical calculations or theory. For those interested in the associated equations, supplemental figures are presented for each test with respective formulas. In addition, Appendix D presents the equations and proof for every output result for the various examples. Examples and results from the appropriate statistical results are displayed using Minitab 18Ò. In addition to the results, the required steps to analyze data using Minitab are presented with the examples for those having access to this software. Numerous other software packages are available, including based data analysis with Excel.
Author: David G. Watson
Publisher: Elsevier Health Sciences
ISBN: 0702069884
Category : Medical
Languages : en
Pages : 598
Get Book Here
Book Description
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 electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now comes with an e-book on StudentConsult. Self-assessment is interactive in the accompanying online e-book. 65 online animations show concepts such as ionization partitioning of drug molecules etc. ~
Author: Nema
Publisher:
ISBN: 9788123916170
Category :
Languages : en
Pages : 207
Get Book Here
Book Description
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
Get Book Here
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Niladry Sekhar Ghosh
Publisher: Sankalp Publication
ISBN: 9391173128
Category : Education
Languages : en
Pages : 122
Get Book Here
Book Description
: The B. Pharmacy students are intended to use this laboratory manual. The topics covered in the text are generally connected to Pharmaceutical Analysis I. The practical work began with an introduction to laboratory techniques used in analysis, like weighing and volumetric apparatus and their calibration, followed by standardisation procedures as per the syllabus of PCI. The assay of specific drugs is then performed in accordance with the syllabus. After that, electro-analytical procedures are provided. Appropriate explanations have been given for each practice. A few interesting questions for oral exams are provided at the conclusion of each chapter. The bibliography is given on the last pages of the book.
Author: Randhir Singh Dahiya
Publisher: Pharmamed Press
ISBN: 9789352301102
Category : Medical
Languages : en
Pages : 312
Get Book Here
Book Description
This manual consists of different chapters dealing with the detailed information of pharmaceutical analytical techniques and organized according to the type of titration or techniques. Each technique is explained along with the experiments.This manual will suffice the requirements of academics and research
Author: A. H. Beckett
Publisher: A&C Black
ISBN: 9780485113235
Category : Science
Languages : en
Pages : 630
Get Book Here
Book Description
This Fourth Edition has been thoroughly revised and updated to take account of international developments in pharaceutical chemistry and to maintain the position of Practical Pharmaceutical Chemistry as the leading University textbook in the field of pharaceutical analysis and quality control. Part 2 deals with physical techniques of analysis for more advanced courses. It gives a broad coverage of the most widely used techniques in quantative chromatography. The treatmentof spectroscopy and radiopharmaceuticals has also been increased. Thre are additional chapters on the contribution and role of physical methods of analysis in the various stages of drug development; and a series of workshop-style exercises, illustrating the application of spectroscopic techniques in structural elucidation and verification of identity. Users of the two volumes will welcome the internationalisation of the text, with examples based on drugs and dosage forms that are widespread and in commun use in human medicine in Britain, continental Europe and North America. Additionally there is some reference to veterinary pharmaceuticals where they provide appropriate examples.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
Get Book Here
Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: James M. Miller
Publisher: Wiley-Interscience
ISBN:
Category : Medical
Languages : en
Pages : 520
Get Book Here
Book Description
Based on the Laboratory Analyst Training and Certification Program ... chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly .... Among the topics are the drug development process, uniform and consistent interpretation of compliance issues, the role of statistics and basic topics in analytical chemistry, and detectors and quantitative analysis. The emphasis is on high-performance liquid chromatographic methods.
Author: Yvonne Bouwman-Boer
Publisher: Springer
ISBN: 3319158147
Category : Medical
Languages : en
Pages : 873
Get Book Here
Book Description
This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.
