Categories
Technical
-- Database/SQL
-- Multimedia
-- Internet/Networking
-- Operating System
-- Programming
-- Security/Hacking
-- Science/Engineering
-- Web/HTML/CSS/Ajax
-- Unix/Linux
-- Windows
-- Mac OS X
-- Office
-- Perl/PHP/Python
-- C/C++/C#
-- .NET
-- Java
-- Hardware
-- Game Development
-- Embedded Systems
-- Graphics and Design
-- Network Programming
Study
Novel
Nonfiction
Health
Tutorial
Entertainment
Business
Magazine
Arts & Design
Audiobooks & Video Training
Cultures & Languages
Family & Home
Law & Politics
Lyrics & Music
Software Related
eBook Torrents
Uncategorized
-- Database/SQL
-- Multimedia
-- Internet/Networking
-- Operating System
-- Programming
-- Security/Hacking
-- Science/Engineering
-- Web/HTML/CSS/Ajax
-- Unix/Linux
-- Windows
-- Mac OS X
-- Office
-- Perl/PHP/Python
-- C/C++/C#
-- .NET
-- Java
-- Hardware
-- Game Development
-- Embedded Systems
-- Graphics and Design
-- Network Programming
Study
Novel
Nonfiction
Health
Tutorial
Entertainment
Business
Magazine
Arts & Design
Audiobooks & Video Training
Cultures & Languages
Family & Home
Law & Politics
Lyrics & Music
Software Related
eBook Torrents
Uncategorized
Share With Friends
Archive by Date
2012-08-06
2012-08-05
2012-08-04
2012-08-03
2012-08-02
2012-08-01
2012-07-31
2012-07-30
2012-07-29
2012-07-28
2012-08-05
2012-08-04
2012-08-03
2012-08-02
2012-08-01
2012-07-31
2012-07-30
2012-07-29
2012-07-28
Search Tag
doesn
teikneseriar
anarchy
Extortion
Capron
linguaggio
交通运输
Prestia
Actuator
Genomes
handwriting
Speedy
Julien
Farnsworth
pinhole
Bingen
Brandyjack
Provisions
考验
Notizen
Fiske
Dominik
危机
Galuppi
Sato
Cinderella
Changing
AISI
Closer
Eighties
Nishinaka
开心
Ithaca
Signum
克伦威尔
Desaster
Catharine
Embarrassment
ANATOMIA
1080p
Vincikoden
Motherly
Audacity
Autonome
Piers
Tharaud
Nannten
Nevill
Linearly
Arcadium
Newest
Learning Core Audio: A Hands-On Guide to Audio Programming for Mac and iOS
Introduction to Programming with Fortran: with coverage of Fortran 90, 95, 2003 and 77
Introduction to Programming with Fortran - with coverage of Fortran 90, 95, 2003 and 77
MATLAB - Modelling, Programming and Simulations
-MATLAB: Modelling, Programming and Simulations- ed. by Emilson Pereira Leite (Repost)
Introduction to Programming with Fortran: with coverage of Fortran 90, 95, 2003 and 77 [Repost]
An Introduction to Programming and Numerical Methods in MATLAB [Repost]
"MATLAB: Modelling, Programming and Simulations" ed. by Emilson Pereira Leite (Repost)
Programming Social Applications: Building Viral Experiences with OpenSocial, OAuth, OpenID, and Distributed Web... (repost)
MATLAB Programming for Engineers (2nd edition) [Repost]
Sriranga Veeraraghavan, "Sams Teach Yourself Shell Programming in 24 Hours" (Repost)
Programming Computer Vision with Python - Tools and algorithms for analyzing images
Matlab: A Practical Introduction to Programming and Problem Solving (2nd edition) [Repost]
ECOOP 2011 - Object-Oriented Programming
Mobile JavaScript Application Development - Bringing Web Programming to Mobile Devices [Paperback]
Concurrent Programming on Windows (repost)
Expert WSS 3.0 and MOSS 2007 Programming (repost)
Embedded Software Design and Programming of Multiprocessor System-on-Chip (repost)
OpenCV 2 Computer Vision Application Programming Cookbook
Programming Computer Vision with Python: Tools and algorithms for analyzing images
Introduction to Programming with Fortran: with coverage of Fortran 90, 95, 2003 and 77
Introduction to Programming with Fortran - with coverage of Fortran 90, 95, 2003 and 77
MATLAB - Modelling, Programming and Simulations
-MATLAB: Modelling, Programming and Simulations- ed. by Emilson Pereira Leite (Repost)
Introduction to Programming with Fortran: with coverage of Fortran 90, 95, 2003 and 77 [Repost]
An Introduction to Programming and Numerical Methods in MATLAB [Repost]
"MATLAB: Modelling, Programming and Simulations" ed. by Emilson Pereira Leite (Repost)
Programming Social Applications: Building Viral Experiences with OpenSocial, OAuth, OpenID, and Distributed Web... (repost)
MATLAB Programming for Engineers (2nd edition) [Repost]
Sriranga Veeraraghavan, "Sams Teach Yourself Shell Programming in 24 Hours" (Repost)
Programming Computer Vision with Python - Tools and algorithms for analyzing images
Matlab: A Practical Introduction to Programming and Problem Solving (2nd edition) [Repost]
ECOOP 2011 - Object-Oriented Programming
Mobile JavaScript Application Development - Bringing Web Programming to Mobile Devices [Paperback]
Concurrent Programming on Windows (repost)
Expert WSS 3.0 and MOSS 2007 Programming (repost)
Embedded Software Design and Programming of Multiprocessor System-on-Chip (repost)
OpenCV 2 Computer Vision Application Programming Cookbook
Programming Computer Vision with Python: Tools and algorithms for analyzing images
Useful Links
Programming Development and Validation of Analytical Methods by: C.M. Riley, T.W. Rosanske
Posted on 2010-03-16
|
More Development and Validation of Analytical Methods (Progress in Pharmaceutical and Biomedical Analysis) by: C.M. Riley, T.W. Rosanske 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. 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. 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. 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. 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.
Rating:
2.5 out of 5 by Book123 |
Download Links | |
Server | Status |
---|---|
Direct Download Link 1 | Alive |
Direct Download Link 2 | Alive |
Download Link (Download link) | Alive |
Download Link (RS) | Alive |
Buy This Book at Best Price >> |
Like this article?! Give us +1: