000			03966nam a22004575i 4500
001			978-3-319-02201-7
003			DE-He213
005			20140220082510.0
007			cr nn 008mamaa
008			131025s2014 gw | s |||| 0|eng d
020			_a9783319022017 _9978-3-319-02201-7
024	7		_a10.1007/978-3-319-02201-7 _2doi
050		4	_aRS380
050		4	_aRS190-210
072		7	_aTDCW _2bicssc
072		7	_aMED072000 _2bisacsh
082	0	4	_a615.19 _223
100	1		_aMochly-Rosen, Daria. _eeditor.
245	1	2	_aA Practical Guide to Drug Development in Academia _h[electronic resource] : _bThe SPARK Approach / _cedited by Daria Mochly-Rosen, Kevin Grimes.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2014.
300			_aXII, 176 p. 9 illus., 4 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
490	1		_aSpringerBriefs in Pharmaceutical Science & Drug Development, _x1864-8118
505	0		_aAdvancing 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			_aWritten 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	_aMedicine.
650		0	_aPharmaceutical technology.
650	1	4	_aBiomedicine.
650	2	4	_aPharmaceutical Sciences/Technology.
700	1		_aGrimes, Kevin. _eeditor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783319022000
830		0	_aSpringerBriefs in Pharmaceutical Science & Drug Development, _x1864-8118
856	4	0	_uhttp://dx.doi.org/10.1007/978-3-319-02201-7
912			_aZDB-2-SME
999			_c92828 _d92828