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Author : Roger E. Schirmer
Publisher : CRC PressI Llc
Page : 243 pages
File Size : 47,6 Mb
Release : 1982
Category : Medical
ISBN : 0849352460
Author : Roger E. Schirmer
Publisher : CRC Press
Page : 472 pages
File Size : 48,7 Mb
Release : 1990-11-30
Category : Medical
ISBN : 0849352665
Author : Roger E. Schirmer
Publisher : Springer
Page : 296 pages
File Size : 49,9 Mb
Release : 1982-01-05
Category : Medical
ISBN : UOM:39015000816523
Vols. -3: Edited by Roger E. Schirmer.
Author : Anette Müllertz,Yvonne Perrie,Thomas Rades
Publisher : Springer
Page : 838 pages
File Size : 55,6 Mb
Release : 2016-08-30
Category : Medical
ISBN : 9781493940295
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 : David C Lee,Michael L. Webb
Publisher : John Wiley & Sons
Page : 384 pages
File Size : 54,6 Mb
Release : 2009-02-12
Category : Science
ISBN : 9781405172998
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 : Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger
Publisher : CRC Press
Page : 561 pages
File Size : 52,7 Mb
Release : 2020-04-15
Category : Medical
ISBN : 9781351718660
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 : Lukasz Komsta,Monika Waksmundzka-Hajnos,Joseph Sherma
Publisher : CRC Press
Page : 1070 pages
File Size : 53,6 Mb
Release : 2013-12-20
Category : Medical
ISBN : 9781466507159
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 : Oona McPolin
Publisher : Lulu.com
Page : 154 pages
File Size : 52,5 Mb
Release : 2009-05-01
Category : Medical
ISBN : 9780956152817
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 : Unknown
Page : 272 pages
File Size : 49,9 Mb
Release : 1982
Category : Drugs
ISBN : UOM:39015000816531
Author : Joachim Ermer,Phil W. Nethercote
Publisher : John Wiley & Sons
Page : 451 pages
File Size : 55,9 Mb
Release : 2014-08-27
Category : Medical
ISBN : 9783527672189
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.
Author : Steen Hansen,Steen Honoré Hansen,Stig Pedersen-Bjergaard,Knut Rasmussen
Publisher : John Wiley & Sons
Page : 511 pages
File Size : 47,8 Mb
Release : 2011-12-12
Category : Medical
ISBN : 9780470661222
This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples
Author : Annpey Pong,Shein-Chung Chow
Publisher : CRC Press
Page : 496 pages
File Size : 45,8 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 1439810176
In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip
Author : Erno Tyihak
Publisher : Elsevier
Page : 524 pages
File Size : 48,9 Mb
Release : 2015-12-01
Category : Science
ISBN : 9780124202122
Forced-Flow Layer Chromatography takes a close look at the specifics of forced-flow layer chromatography techniques, from their evolution to the nuances of using these techniques in a variety of applications where traditional thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC) are not as effective. This book presents a number of variations of TLC techniques, with special emphasis on the overpressured-layer chromatography (OPLC) technique and newer developments such as the BioArena System for biomedical analysis. The versatility of these forced-flow techniques opens up new avenues for the analysis of a large number of samples for high-throughput screening and for the analysis of very complex matrices, while the development of BioArena extends the use of these techniques to challenging new areas of bioanalysis. Details a variety of forced-flow techniques, explaining how they markedly reduce developing time and result in less lateral diffusion and more compact spots Emphasizes the benefits of OPLC separation techniques, a method pioneered by the authors nearly forty years ago Discusses new developments, such as the BioArena system used to facilitate detection, isolation, and identification of new antimicrobials, antineoplastics, biopesticides, and other biologically active substances
Author : James W. Munson
Publisher : CRC Press
Page : 496 pages
File Size : 42,5 Mb
Release : 1984-11-30
Category : Medical
ISBN : 0824772512
Author : Muhammad Sajid Hamid Akash,Kanwal Rehman
Publisher : Springer Nature
Page : 235 pages
File Size : 46,9 Mb
Release : 2019-12-17
Category : Medical
ISBN : 9789811515477
Recent advances in the pharmaceutical sciences and biotechnology have facilitated the production, design, formulation and use of various types of pharmaceuticals and biopharmaceuticals. This book provides detailed information on the background, basic principles, and components of techniques used for the analysis of pharmaceuticals and biopharmaceuticals. Focusing on those analytical techniques that are most frequently used for pharmaceuticals, it classifies them into three major sections and 19 chapters, each of which discusses a respective technique in detail. Chiefly intended for graduate students in the pharmaceutical sciences, the book will familiarize them with the components, working principles and practical applications of these indispensable analytical techniques.