LEADER 00000cam a2200625Mi 4500 
001    ocn861537317 
003    OCoLC 
005    20160805111135.9 
006    m     o  d         
007    cr cn||||||||| 
008    131008t20142014ne a    ob    001 0 eng d 
019    863821936|a880437636 
020    9780080983431|q(electronic book) 
020    008098343X|q(electronic book) 
020    |z9780080983509 
020    |z0080983502|q(hardback) 
035    (OCoLC)861537317|z(OCoLC)863821936|z(OCoLC)880437636 
040    E7B|beng|erda|epn|cE7B|dN$T|dOPELS|dYDXCP|dOCLCF|dGGVRL
       |dUWO|dEBLCP|dUKDOC|dOCLCQ 
049    RIDW 
050  4 RS189|b.S64 2014eb 
072  7 MED|x071000|2bisacsh 
082 04 615.19 
090    RS189|b.S64 2014eb 
245 00 Specification of drug substances and products :
       |bdevelopment and validation of analytical methods /
       |cedited by Christopher M. Riley, Riley and Rabel 
       Consulting Services, Maryville, MO, USA, Thomas W. 
       Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA,
       Shelley R, Rabel Riley, Department of Natural Sciences, 
       Northwest Missouri State University, Maryville, MO, USA ; 
       Riley and Rabel Consulting Services, Maryville, MO, USA. 
264  1 Amsterdam :|bElsevier,|c[2014] 
264  4 |c©2014 
300    1 online resource (389 pages) :|billustrations. 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
340    |gpolychrome|2rdacc 
347    text file|2rdaft 
490 1  Progress in Pharmaceutical and Biomedical Analysis 
504    Includes bibliographical references and index. 
505 0  Part 1. Introduction -- part 2. Universal tests -- part 3.
       Specific tests : drug substance -- part 4. Specific tests 
       : drug product -- part 5. Pharmacopeial methods -- part 6.
       Microbial methods -- part 7. Biological fluids. 
520    Specification of Drug Substances and Products: Development
       and Validation of Analytical Methods is a comprehensive 
       and critical analysis of the requirements and approaches 
       to setting specifications for new pharmaceutical products,
       with an emphasis on phase-appropriate development and 
       validation of analytical methods. This book is intended as
       more than a review of new regional guidelines, existing 
       regulatory guidance, and industry practices. It provides a
       hands-on guide to understanding and applying these in 
       practice. The authors discuss critical issues, novel 
       approaches, and future directions while also providing 
       insight into how International Guidelines were developed 
       and the rationale behind them. Guide to industry best 
       practices of analytical methodologies used in the 
       specification of new drug substances and products (e.g. 
       DOE, QbD)Critical assessment of the application of ICH 
       guidelines on method validation and specification setting,
       written by experts involved in the development and 
       application of the guidelines to aid understanding of 
       requirements and what is expected by regulatory 
       authoritiesDirect applicability to the day-to-day 
       activities in drug development and the potential to 
       increase productivity. 
588 0  Online resource; title from PDF title page (ebrary, viewed
       October 8, 2013). 
590    eBooks on EBSCOhost|bEBSCO eBook Subscription Academic 
       Collection - North America 
650  0 Drugs|xAnalysis|0https://id.loc.gov/authorities/subjects/
       sh85039722|xMethodology.|0https://id.loc.gov/authorities/
       subjects/sh99001902 
650  7 Drugs|xAnalysis|xMethodology.|2fast|0https://
       id.worldcat.org/fast/898771 
650  7 Drugs|xAnalysis.|2fast|0https://id.worldcat.org/fast/
       898769 
650  7 Medication.|2homoit|0https://homosaurus.org/v3/
       homoit0001007 
655  4 Electronic books. 
700 1  Riley, Christopher M.|0https://id.loc.gov/authorities/
       names/n94801514 
700 1  Rosanske, Thomas W.|0https://id.loc.gov/authorities/names/
       n96800606 
700 1  Riley, Shelley R. Rabel.|0https://id.loc.gov/authorities/
       names/nb2013022672 
776 08 |iPrint version:|tSpecification of drug substances and 
       products.|dAmsterdam : Elsevier, 2014|z9780080983509
       |w(DLC)  2013444132 
830  0 Progress in pharmaceutical and biomedical analysis.|0https
       ://id.loc.gov/authorities/names/n88540690 
856 40 |uhttps://rider.idm.oclc.org/login?url=http://
       search.ebscohost.com/login.aspx?direct=true&scope=site&
       db=nlebk&AN=486507|zOnline eBook. Access restricted to 
       current Rider University students, faculty, and staff. 
856 42 |3Instructions for reading/downloading this eBook|uhttp://
       guides.rider.edu/ebooks/ebsco 
901    MARCIVE 20231220 
948    |d20161013|cEBSCO|tebscoebooksacademic new |lridw 
994    92|bRID