A Practical Guide to Drug Development in Academia (Record no. 92828)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03966nam a22004575i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-3-319-02201-7 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20140220082510.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 131025s2014 gw | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783319022017 |
| -- | 978-3-319-02201-7 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-3-319-02201-7 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS380 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS190-210 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED072000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Mochly-Rosen, Daria. |
| Relator term | editor. |
| 245 12 - TITLE STATEMENT | |
| Title | A Practical Guide to Drug Development in Academia |
| Medium | [electronic resource] : |
| Remainder of title | The SPARK Approach / |
| Statement of responsibility, etc | edited by Daria Mochly-Rosen, Kevin Grimes. |
| 264 #1 - | |
| -- | Cham : |
| -- | Springer International Publishing : |
| -- | Imprint: Springer, |
| -- | 2014. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XII, 176 p. 9 illus., 4 illus. in color. |
| Other physical details | online resource. |
| 336 ## - | |
| -- | text |
| -- | txt |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | c |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | cr |
| -- | rdacarrier |
| 347 ## - | |
| -- | text file |
| -- | |
| -- | rda |
| 490 1# - SERIES STATEMENT | |
| Series statement | SpringerBriefs in Pharmaceutical Science & Drug Development, |
| International Standard Serial Number | 1864-8118 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Advancing New Treatments to the Clinic within Academia -- Overview of Drug Discovery and Development -- Assessing Clinical Need -- Target Product Profile (TPP) -- Project Management and Project Planning -- Robustness of Preclinical Studies -- Repurposing Drugs -- Developing Assays for High Throughput Screening (HTS) -- Medicinal Chemistry and Lead Optimization -- Vaccine Development -- When to Begin Animal Studies -- In vivo pharmacology: Multiple Roles in Drug Discovery -- Pharmacokinetics and ADME Properties -- Route of Administration and Drug Formulation -- Preclinical Safety Studies -- Regulatory Considerations in Product Development -- Manufacturing and Quality Control -- Technical Development and Manufacturing of Biological Products -- Clinical Trial Design -- Overview of Clinical Trials -- Intellectual Property -- Working with the University Technology Transfer Office -- Avoiding Conflicts of Interest -- Working with the University Compliance Office -- Selecting the Market for Your Drug -- Commercial Assessments -- Making a Compelling Pitch to Potential Investors -- Venture Capital Funding -- Not-For-Profit Drug Development -- Legal Aspects of a Start-up Biotechnology Company -- Founder Preferred Stock -- Plan, Organize, Motivate and Control -- A Call to Action: Changing How We Pursue Drug Discovery and Development. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical technology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biomedicine. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical Sciences/Technology. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Grimes, Kevin. |
| Relator term | editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Printed edition: |
| International Standard Book Number | 9783319022000 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | SpringerBriefs in Pharmaceutical Science & Drug Development, |
| -- | 1864-8118 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://dx.doi.org/10.1007/978-3-319-02201-7 |
| 912 ## - | |
| -- | ZDB-2-SME |
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