|
|
|
|
| LEADER |
00000cam a2200000Mu 4500 |
| 001 |
EBOOKCENTRAL_on1011219313 |
| 003 |
OCoLC |
| 005 |
20240329122006.0 |
| 006 |
m o d |
| 007 |
cr |n|---||||| |
| 008 |
171111s2017 mou o 000 0 eng d |
| 040 |
|
|
|a EBLCP
|b eng
|e pn
|c EBLCP
|d OCLCQ
|d INT
|d OCLCQ
|d LOA
|d OCLCO
|d OCLCF
|d OCLCO
|d K6U
|d OCLCQ
|d OCLCO
|
| 020 |
|
|
|a 9780128020982
|
| 020 |
|
|
|a 0128020989
|
| 029 |
1 |
|
|a AU@
|b 000068486652
|
| 035 |
|
|
|a (OCoLC)1011219313
|
| 050 |
|
4 |
|a R850
|b .P437 2018
|
| 082 |
0 |
4 |
|a 616.0072
|2 23
|
| 049 |
|
|
|a UAMI
|
| 100 |
1 |
|
|a Vohora, Divya.
|
| 245 |
1 |
0 |
|a Pharmaceutical Medicine and Translational Clinical Research.
|
| 260 |
|
|
|a Saint Louis :
|b Elsevier Science,
|c 2017.
|
| 300 |
|
|
|a 1 online resource (527 pages)
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 588 |
0 |
|
|a Print version record.
|
| 505 |
0 |
|
|a Front Cover -- Pharmaceutical Medicine and Translational Clinical Research -- Copyright Page -- Contents -- List of Contributors -- About the Editors -- Foreword -- Preface -- I. Overview of Pharmaceutical Medicine -- 1 The Specialty of Pharmaceutical Medicine -- 1.1 What is Pharmaceutical Medicine? -- 1.2 Origin and Development of Pharmaceutical Medicine -- 1.3 Present State of the Specialty of Pharmaceutical Medicine -- 1.4 State of Affairs in Pharmaceutical Medicine in Selected Countries -- 1.4.1 Hungary -- 1.4.2 India -- 1.4.3 Mexico
|
| 505 |
8 |
|
|a 1.4.4 Switzerland1.4.5 UK -- 1.4.6 Emerging Countries -- 1.5 Conclusions and Outlook -- References -- II. Drug Discovery and Development -- 2 Drug Discovery and Development: An overview -- 2.1 Introduction -- 2.2 Identification of Unmet Medical Need -- 2.3 Target Identification -- 2.4 Target Validation -- 2.5 Hit Identification and Development of Assays -- 2.6 Confirmation of Hits -- 2.7 Lead Generation -- 2.8 Lead Optimization -- 2.9 Preclinical Drug Development -- 2.10 Criteria to Select a Clinical Candidate -- 2.11 Clinical Drug development
|
| 505 |
8 |
|
|a 2.12 Other Approaches in Drug Discovery and Development2.13 Conclusion -- Acknowledgments -- References -- 3 Pharmaceutical Development -- 3.1 Introduction -- 3.2 Elements of Pharmaceutical Development -- 3.2.1 Quality Target Product Profile -- 3.2.2 Critical Quality Attributes (CQA) -- 3.2.3 Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs -- 3.2.4 Preformulation -- 3.2.4.1 Drug substance -- 3.2.4.2 Excipients -- 3.2.4.3 Overages -- 3.2.4.4 Physicochemical and Biological Properties -- 3.2.5 Design Space
|
| 505 |
8 |
|
|a 3.2.6 Formulation Development3.2.6.1 Prototype development -- 3.2.7 Control Strategy -- 3.2.8 Scaleup and Stability Study of Batch -- 3.2.9 Analytical Method Validation -- 3.2.10 Documentation -- 3.2.10.1 IPR and regulatory clearance -- 3.2.10.2 Technology transfer dossier -- 3.2.10.3 Technology transfer from R & D to production -- 3.2.10.4 Master formula card (MFC) includes -- 3.2.10.5 Master packaging card -- 3.2.10.6 Master formula -- 3.2.10.7 Specifications and standard test procedure (STPs) -- 3.2.11 Exhibit Batch Manufacturing
|
| 505 |
8 |
|
|a 3.2.11.1 Validation batch3.2.11.2 The validation report -- 3.2.11.3 Pivotal BE Studies -- 3.2.11.4 Dossier Compilation and filling -- 3.2.12 Product Lifecycle Management and Continual Improvement -- 3.3 Conclusion -- References -- 4 Preclinical Drug Development -- 4.1 Introduction -- 4.2 Pharmacokinetic and Metabolism Studies -- 4.3 Safety Pharmacology Studies -- 4.3.1 Introduction and Objectives -- 4.3.2 Route/Dose and Duration -- 4.3.3 Type of Safety Pharmacology Studies -- 4.3.4 Timing of Safety Pharmacology Studies -- 4.4 Toxicology Studies
|
| 500 |
|
|
|a ""4.4.1 Systemic Toxicology Studies""
|
| 590 |
|
|
|a ProQuest Ebook Central
|b Ebook Central Academic Complete
|
| 650 |
|
0 |
|a Clinical medicine
|x Research.
|
| 650 |
|
2 |
|a Research Design
|
| 650 |
|
6 |
|a Médecine clinique
|x Recherche.
|
| 650 |
|
7 |
|a Clinical medicine
|x Research
|2 fast
|
| 700 |
1 |
|
|a Singh, Gursharan.
|
| 776 |
0 |
8 |
|i Print version:
|a Vohora, Divya.
|t Pharmaceutical Medicine and Translational Clinical Research.
|d Saint Louis : Elsevier Science, ©2017
|z 9780128021033
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=5122255
|z Texto completo
|
| 938 |
|
|
|a EBL - Ebook Library
|b EBLB
|n EBL5122255
|
| 994 |
|
|
|a 92
|b IZTAP
|
