Detalles MARC
| 000 -CABECERA |
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| Longitud fija campo de control |
05279nam a2200325Ia 4500 |
| 003 - IDENTIFICADOR DEL NÚMERO DE CONTROL |
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| Identificador del número de control |
OSt |
| 008 - CÓDIGOS DE INFORMACIÓN DE LONGITUD FIJA |
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| Códigos de información de longitud fija |
070806s1996 nyua b 001 0 eng d |
| 020 ## - NÚMERO INTERNACIONAL NORMALIZADO PARA LIBROS |
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| Número Internacional Normalizado para Libros (ISBN) |
9780080427928 |
| 020 ## - NÚMERO INTERNACIONAL NORMALIZADO PARA LIBROS |
|---|
| Número Internacional Normalizado para Libros (ISBN) |
0080427928 |
| 040 ## - FUENTE DE LA CATALOGACIÓN |
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| Centro catalogador |
UCA |
| Centro transcriptor |
UCA |
| 245 00 - MENCIÓN DE TÍTULO |
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| Título |
Development and validation of analytical methods / |
| Mención de responsabilidad, etc. |
edited by Christopher M. Riley and Thomas W. Rosanske. |
| 260 ## - PUBLICACIÓN, DISTRIBUCIÓN, ETC. (PIE DE IMPRENTA) |
|---|
| Lugar de publicación, distribución, etc. |
Tarrytown, N.Y. : |
| Nombre del editor, distribuidor, etc. |
Pergamon, |
| Fecha de publicación, distribución, etc. |
1996. |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Extensión |
x, 352 p. : |
| Otras características físicas |
ill. ; |
| Dimensiones |
24 cm. |
| 490 00 - MENCIÓN DE SERIE |
|---|
| Mención de serie |
Progress in pharmaceutical and biomedical analysis ; |
| Designación de volumen o secuencia |
v. 3. |
| 506 ## - NOTA DE RESTRICCIONES AL ACCESO |
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| Limitaciones de acceso |
Acceso restringido a miembros del Consorcio de Bibliotecas Universitarias de Andalucía. |
| 520 ## - NOTA DE SUMARIO |
|---|
| Sumario, etc, |
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. <P>The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. <P>Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. <P>Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. <P>This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation. |
| 505 0# - NOTA DE CONTENIDO CON FORMATO |
|---|
| Nota de contenido con formato |
Section headings and papers: List of Contributors. Introduction. Basic Concepts. Assay validation and inter-laboratory transfer (E. McGonigle). Statistical parameters and analytical figures of merit (C.M. Riley). Regulatory Considerations. Overview of worldwide regulations (I.E. Davidson). Issues related to United States v. Barr Laboratories Inc. (C.L. Burgess). Judge Wolin's interpretations of current good manufacturing practice issues contained in the court's ruling in the United States v. Barr Laboratories (R.J. Davis). Specific Methods and Applications. Bulk drug substances and finished products (P.K. Hovsepian). Dissolution studies (T.W. Rosanske, C.K. Brown). Robotics and automated workstations (J.J. Tomlinson). Biotechnology products (G.S. Srivatsa). Biological samples (K.A. Selinger). Analytical methods for cleaning procedures (T.M. Rossi, R.R. Ryall). Computer systems and computer-aided validation (J.G. Liscouski). Index. |
| 504 ## - NOTA DE BIBLIOGRAFÍA, ETC |
|---|
| Nota de bibliografía, etc. |
Includes bibliographical references and index. |
| 530 ## - NOTA DE FORMATO FÍSICO ADICIONAL DISPONIBLE |
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| Nota de formato físico adicional disponible |
También disponible en versión electrónica. |
| Fuente para la adquisición |
Consulte en Libros y Revistas electrónicas (http://goo.gl/Ygwy4z) |
| 650 04 - PUNTO DE ACCESO ADICIONAL DE MATERIA - TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento inicial |
Química analítica |
| Subdivisión de materia general |
Metodología |
| 650 04 - PUNTO DE ACCESO ADICIONAL DE MATERIA - TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento inicial |
Drogas |
| Subdivisión de materia general |
Análisis |
| 650 #0 - PUNTO DE ACCESO ADICIONAL DE MATERIA - TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento inicial |
Drugs |
| Subdivisión de materia general |
Analysis |
| -- |
Methodology. |
| 650 12 - PUNTO DE ACCESO ADICIONAL DE MATERIA - TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento inicial |
Chemistry, Pharmaceutical |
| Subdivisión de materia general |
methods. |
| 650 22 - PUNTO DE ACCESO ADICIONAL DE MATERIA - TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento inicial |
Pharmaceutical Preparations |
| Subdivisión de materia general |
analysis. |
| 700 1# - PUNTO DE ACCESO ADICIONAL - NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Riley, Christopher M. |
| 700 1# - PUNTO DE ACCESO ADICIONAL - NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Rosanske, Thomas W. |
| 909 ## - No. registro Millennium |
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| -- |
cyt |
| -- |
- |
| 942 ## - ENTRADA DE ELEMENTOS AGREGADOS (KOHA) |
|---|
| Suprimir del OPAC |
No |
| 998 ## - CONTROL LOCAL DE INFORMACIÓN (RLIN) |
|---|
| Iniciales de operador, IOP (RLIN) |
1 |
| Iniciales de catalogador, INC (RLIN) |
080324 |
| Primera fecha, PF (RLIN) |
m |
| -- |
a |
| -- |
- |
| -- |
0 |