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Author : Roger E. Schirmer
Publisher : CRC PressI Llc
ISBN 13 : 9780849352461
Total Pages : 243 pages
Book Rating : 4.60/5 ( download)
Download or read book Modern Methods of Pharmaceutical Analysis written by Roger E. Schirmer and published by CRC PressI Llc. This book was released on 1982 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Roger E. Schirmer
Publisher : CRC Press
ISBN 13 : 9780849352669
Total Pages : 472 pages
Book Rating : 4.65/5 ( download)
Download or read book Modern Methods of Pharmaceutical Analysis, Second Edition written by Roger E. Schirmer and published by CRC Press. This book was released on 1990-11-30 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Roger E. Schirmer
Publisher : Springer
ISBN 13 :
Total Pages : 296 pages
Book Rating : 4.23/5 ( download)
Download or read book Mod Methods of Pharmaceutical Analysis written by Roger E. Schirmer and published by Springer. This book was released on 1982-01-05 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. -3: Edited by Roger E. Schirmer.
Author : Lukasz Komsta
Publisher : CRC Press
ISBN 13 : 1466507152
Total Pages : 1070 pages
Book Rating : 4.59/5 ( download)
Download or read book Thin Layer Chromatography in Drug Analysis written by Lukasz Komsta and published by CRC Press. This book was released on 2013-12-20 with total page 1070 pages. Available in PDF, EPUB and Kindle. Book excerpt: Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date, complete reference, Thin Layer Chromatography in Drug Analysis covers the most important methods in pharmaceutical applications of TLC, namely, analysis of bulk drug material and pharmaceutical formulations, degradation studies, analysis of biological samples, optimization of the separation of drug classes, and lipophilicity estimation. The book is divided into two parts. Part I is devoted to general topics related to TLC in the context of drug analysis, including the chemical basis of TLC, sample pleparation, the optimization of layers and mobile phases, detection and quantification, analysis of ionic compounds, and separation and analysis of chiral substances. The text addresses the newest advances in TLC instrumentation, two-dimensional TLC, quantification by slit scanning densitometry and image analysis, statistical processing of data, and various detection and identification methods. It also describes the use of TLC for solving a key issue in the drug market—the presence of substandard and counterfeit pharmaceutical products. Part II provides an in-depth overview of a wide range of TLC applications for separation and analysis of particular drug groups. Each chapter contains an introduction about the structures and medicinal actions of the described substances and a literature review of their TLC analysis. A useful resource for chromatographers, pharmacists, analytical chemists, students, and R&D, clinical, and forensic laboratories, this book can be utilized as a manual, reference, and teaching source.
Author : David C Lee
Publisher : John Wiley & Sons
ISBN 13 : 1405172991
Total Pages : 384 pages
Book Rating : 4.98/5 ( download)
Download or read book Pharmaceutical Analysis written by David C Lee and published by John Wiley & Sons. This book was released on 2009-02-12 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.
Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 838 pages
Book Rating : 4.95/5 ( download)
Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Emmanuel Lesaffre
Publisher : CRC Press
ISBN 13 : 1351718665
Total Pages : 561 pages
Book Rating : 4.60/5 ( download)
Download or read book Bayesian Methods in Pharmaceutical Research written by Emmanuel Lesaffre and published by CRC Press. This book was released on 2020-04-15 with total page 561 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
Author : Oona McPolin
Publisher : Lulu.com
ISBN 13 : 0956152813
Total Pages : 154 pages
Book Rating : 4.17/5 ( download)
Download or read book Validation of Analytical Methods for Pharmaceutical Analysis written by Oona McPolin and published by Lulu.com. This book was released on 2009-05-01 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Author : Roger E. Schirmer
Publisher :
ISBN 13 :
Total Pages : 272 pages
Book Rating : 4.31/5 ( download)
Download or read book Modern Methods of Pharmaceutical Analysis written by Roger E. Schirmer and published by . This book was released on 1982 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527672184
Total Pages : 451 pages
Book Rating : 4.89/5 ( download)
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2014-08-27 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.
