Modern Methods of Pharmaceutical Analysis
Author : Roger E. Schirmer
Publisher : CRC PressI Llc
Page : 243 pages
File Size : 28,87 MB
Release : 1982
Category : Medical
ISBN : 9780849352461
Author : Roger E. Schirmer
Publisher : CRC PressI Llc
Page : 243 pages
File Size : 28,87 MB
Release : 1982
Category : Medical
ISBN : 9780849352461
Author : Roger E. Schirmer
Publisher : CRC Press
Page : 472 pages
File Size : 46,77 MB
Release : 1990-11-30
Category : Medical
ISBN : 9780849352669
Author : Roger E. Schirmer
Publisher : Springer
Page : 296 pages
File Size : 37,56 MB
Release : 1982-01-05
Category : Medical
ISBN :
Vols. -3: Edited by Roger E. Schirmer.
Author : Anette Müllertz
Publisher : Springer
Page : 829 pages
File Size : 49,35 MB
Release : 2016-08-30
Category : Medical
ISBN : 1493940295
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
Publisher : John Wiley & Sons
Page : 384 pages
File Size : 50,92 MB
Release : 2009-02-12
Category : Science
ISBN : 1405172991
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 : Joachim Ermer
Publisher : John Wiley & Sons
Page : 451 pages
File Size : 25,73 MB
Release : 2014-11-10
Category : Medical
ISBN : 3527335633
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 : James W. Munson
Publisher :
Page : pages
File Size : 49,21 MB
Release : 1981
Category : Drogas - Analisis
ISBN :
Author : Lena Ohannesian
Publisher : CRC Press
Page : 605 pages
File Size : 18,1 MB
Release : 2001-11-09
Category : Medical
ISBN : 0824741943
Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.
Author : Lukasz Komsta
Publisher : CRC Press
Page : 1070 pages
File Size : 46,47 MB
Release : 2013-12-20
Category : Medical
ISBN : 1466507152
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 :
Publisher :
Page : 0 pages
File Size : 16,57 MB
Release : 2003
Category :
ISBN :