Specification of drug substances and products : development and validation of analytical methods

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate developm...

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Bibliographic Details
Other Authors: Riley, Christopher M., (Editor), Rosanske, Thomas W., (Editor), Reid, George L., (Editor)
Format: eBook
Language: English
Published: Amsterdam, Netherlands ; Cambridge, MA : Elsevier, [2020]
Subjects:
Drugs > Standards.
Drug development.
elektronické knihy
electronic books
ISBN: 0081028253
9780081028247
0081028245
9780081028254
Physical Description: 1 online resource

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Table of contents

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001 kn-on1181845371
003 OCoLC
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006 m o d
007 cr cn|||||||||
008 200804s2020 ne o 000 0 eng d
040 |a YDX  |b eng  |e rda  |e pn  |c YDX  |d YDXIT  |d OPELS  |d OCLCO  |d N$T  |d OCLCF  |d OCLCQ  |d OCLCA  |d OCLCO  |d K6U  |d OCLCQ  |d OCLCO  |d OCLCL  |d SXB  |d OCLCQ  |d OCLCO 
020 |a 0081028253  |q (electronic book) 
020 |a 9780081028247  |q (electronic bk.) 
020 |a 0081028245  |q (electronic bk.) 
020 |a 9780081028254  |q (electronic bk.) 
035 |a (OCoLC)1181845371 
245 0 0 |a Specification of drug substances and products :  |b development and validation of analytical methods /  |c edited by Christopher M. Riley, Thomas W. Rosanske, George L. Reid. 
264 1 |a Amsterdam, Netherlands ;  |a Cambridge, MA :  |b Elsevier,  |c [2020] 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Drugs  |x Standards. 
650 0 |a Drug development. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
700 1 |a Riley, Christopher M.,  |e editor.  |1 https://id.oclc.org/worldcat/entity/E39PCjDJrQ4hkGck9Xb8tth9wC 
700 1 |a Rosanske, Thomas W.,  |e editor.  |1 https://id.oclc.org/worldcat/entity/E39PCjJqTJKwbWqB8v7fvDhd73 
700 1 |a Reid, George L.,  |e editor. 
776 0 8 |i Print version:  |z 0081028245  |z 9780081028247  |w (OCoLC)1082966081 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpSDSPDVA1/specification-of-drug?kpromoter=marc  |y Full text 

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