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on1202481099 |
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OCoLC |
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20240623213015.0 |
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m o d |
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cr cnu---unuuu |
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201031s2020 xx o ||| 0 eng d |
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|a EBLCP
|b eng
|c EBLCP
|d EBLCP
|d N$T
|d OCLCO
|d OCLCF
|d OCL
|d OCLCO
|d OCLCQ
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|a 1119547857
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|a 9781119547853
|q (electronic bk.)
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|a (OCoLC)1202481099
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|a RM301.25
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|a HCDD
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| 100 |
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|a Xiao, Kangping.
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|a Analytical Scientists in Pharmaceutical Product Development
|h [electronic resource] :
|b Task Management and Practical Knowledge.
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|a Newark :
|b John Wiley & Sons, Incorporated,
|c 2020.
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| 300 |
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|a 1 online resource (275 p.)
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|a Description based upon print version of record.
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|a Cover -- Title Page -- Copyright Page -- Contents -- Preface -- Chapter 1 Pharmaceutical Development at a Glance -- 1.1 Prescription Medicinal Product Development -- 1.1.1 Active Pharmaceutical Ingredient (API) Development -- 1.1.2 Preclinical Research -- 1.1.3 Clinical Research - Phase 1, Safety and Dosage -- 1.1.4 Clinical Research - Phase 2, Efficacy and Side Effects -- 1.1.5 Clinical Research - Phase 3, Efficacy and Monitoring of Adverse Reactions -- 1.1.6 Clinical Research - Phase 4, Post-Market Safety Monitoring -- 1.1.7 FDA Approval of a Prescription Medicine
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|a 1.2 Over-the-Counter (OTC) Medicinal Product Development -- 1.2.1 FDA Monograph System -- 1.2.2 New Drug Application Process for an OTC Medicinal Product -- 1.2.3 Clinical Trials in OTC Product Development -- 1.2.4 Prescription to OTC Switch -- References -- Chapter 2 Analytics in Fast-Paced Product Development -- 2.1 Overall Development Process for New Products -- 2.2 Regulatory Strategy and Analytical Development -- 2.2.1 NDA and ANDA Filing -- 2.2.2 Module 3 (CMC) of Common Technical Document -- 2.2.3 Supplements and Other Changes to an Approved NDA or ANDA
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|a 2.2.3.1 Major Changes -- Prior Approval Supplement -- 2.2.3.2 Moderate Changes -- CBE-30 -- 2.2.3.3 Moderate Changes -- CBE -- 2.2.3.4 Minor Changes -- Annual Report -- 2.2.4 Analytical Development with FDA Guidelines in Mind -- 2.3 ICH Guidelines and Analytical Development -- 2.4 Pharmacopoeia Monographs and Analytical Development -- 2.5 Formulation Development and Analytical Development -- 2.5.1 Method Development Based on an Ideal, Comprehensive Quality by Design -- 2.5.2 Fit-for-Purpose, Teamwork, Knowledge Sharing, and Platform Approach
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|a 2.6 Methods for Scale-Up and Manufacturing QC Laboratories -- 2.7 Process Analytical Technology -- 2.8 Quality Assurance, Compliance, and Analytical Development -- References -- Chapter 3 Effective, Efficient, and Innovative Analytical Development -- 3.1 Task Management by Fishbone Diagrams and Time-Bars -- 3.2 Project Management - Waterfall Versus Agile -- 3.3 Resource and Cost Estimations -- 3.4 Desired Skill Sets -- 3.5 Analytical Scientists and Innovation -- 3.5.1 Think Outside the Box -- 3.5.2 Think Inside the Box -- 3.5.3 Be Analytically Creative -- References
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|a Chapter 4 Analytical Chemistry and Separation Science at Molecular Level -- 4.1 Ions and Ionic Strength -- 4.2 Protonation and Deprotonation -- 4.3 Hydrolysis of Salts -- 4.4 Charge-Dipole and Dipole-Dipole Interaction -- 4.5 Hydrogen Bonding -- 4.6 Electron Donor-Acceptor Interaction -- 4.7 Hydration and Solvation Energy -- 4.8 Hydrophobic Interactions -- 4.9 Events Happening on the Column Surface -- 4.10 Example Thought Processes of Chromatographic Method Development -- 4.10.1 General Considerations -- 4.10.2 Case Study - Method Development for Assay of Benzalkonium Chloride
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|a Drug development.
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| 650 |
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|a Analytical chemistry.
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| 650 |
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|a chemical analysis.
|2 aat
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| 650 |
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|a Analytical chemistry
|2 fast
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| 650 |
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|a Drug development
|2 fast
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| 758 |
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|i has work:
|a Analytical scientists in pharmaceutical product development (Text)
|1 https://id.oclc.org/worldcat/entity/E39PCFv4hj6P7JfxXtXPv8V7VC
|4 https://id.oclc.org/worldcat/ontology/hasWork
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| 776 |
0 |
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|i Print version:
|a Xiao, Kangping
|t Analytical Scientists in Pharmaceutical Product Development : Task Management and Practical Knowledge
|d Newark : John Wiley & Sons, Incorporated,c2020
|z 9781119547822
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| 856 |
4 |
0 |
|u https://ebookcentral.proquest.com/lib/holycrosscollege-ebooks/detail.action?docID=6369776
|y Click for online access
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|a EBC-AC
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|a 92
|b HCD
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