LEADER 00000cam a2200577Ia 4500 001 ocn880827447 003 OCoLC 005 20190111050803.7 006 m o d 007 cr cnu---unuuu 008 140531s2014 enk o 000 0 eng d 020 9780190200657|q(electronic book) 020 0190200650|q(electronic book) 035 (OCoLC)880827447 040 EBLCP|beng|epn|cEBLCP|dIDEBK|dN$T|dOCLCQ|dMOR|dYDX|dOCLCO |dMERUC|dOCLCO|dOCLCQ|dSAV|dOCLCO|dUAB|dOCLCA|dOCLCQ|dWYU |dOCLCO|dOCLCA 049 RIDW 050 4 RM301.27 072 7 MED|x071000|2bisacsh 082 04 615.1901|223 090 RM301.27 100 1 Tansey, Michael.|0https://id.loc.gov/authorities/names/ n2013187149 245 10 Intelligent Drug Development :|bTrials and Errors in Clinical Research. 264 1 Oxford :|bOxford University Press,|c2014. 300 1 online resource (241 pages) 336 text|btxt|2rdacontent 337 computer|bc|2rdamedia 338 online resource|bcr|2rdacarrier 340 |gpolychrome|2rdacc 347 text file|2rdaft 505 0 Cover; Intelligent Drug Development; Copyright; CONTENTS; Acknowledgments; Intelligent Drug Development; PART ONESetting the Scene; Introduction; Chapter 1 Aiming for Excellence; PART twoPlanning: From Chaos to Cosmos; Chapter 2 The Target Product Profile and Its Uses; Chapter 3 Planning the Individual Clinical Trial; PART ThreeThe Practicable Protocol; Chapter 4 Distilling the Essence of the Protocol: The Protocol Synopsis; Chapter 5 Redistillation: Eliminating Impurities by Carrying out Protocol Feasibility; Chapter 6 The Optimal Blend: The Approved Synopsis and the Final Protocol. 505 8 PART FOURThe Sponsor, The Physician, and The Patient: The Eternal Clinical Trial TriangleChapter 7 Of Chickens and Eggs: The Sponsor's Dilemma; Chapter 8 Clinician or Clinical Trialist: The Physician's Dilemma; Chapter 9 What about the Customer? The Patient's Dilemma; PART FIVEAnd Another Thing ... ; Chapter 10 About Time: Making Meetings Matter; Chapter 11 The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor Laser Show; References; Index. 520 Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the proces. 588 0 Print version record. 590 eBooks on EBSCOhost|bEBSCO eBook Subscription Academic Collection - North America 650 0 Clinical trials|0https://id.loc.gov/authorities/subjects/ sh85027069|xEthics.|0https://id.loc.gov/authorities/ subjects/sh00005644 650 0 Clinical trials|0https://id.loc.gov/authorities/subjects/ sh85027069|xMethods.|0https://id.loc.gov/authorities/ subjects/sh2006007982 650 0 Drug approval|0https://id.loc.gov/authorities/subjects/ sh2002008777|xMethods.|0https://id.loc.gov/authorities/ subjects/sh2006007982 650 0 Medical protocols.|0https://id.loc.gov/authorities/ subjects/sh85083005 650 7 Clinical trials.|2fast|0https://id.worldcat.org/fast/ 864429 650 7 Ethics.|2fast|0https://id.worldcat.org/fast/915833 650 7 Drug approval.|2fast|0https://id.worldcat.org/fast/898661 650 7 Medical protocols.|2fast|0https://id.worldcat.org/fast/ 1014534 655 4 Electronic books. 776 08 |iPrint version:|aTansey, Michael.|tIntelligent Drug Development.|dOxford : Oxford University Press, 2014 |z9780199974580 856 40 |uhttps://rider.idm.oclc.org/login?url=http:// search.ebscohost.com/login.aspx?direct=true&scope=site& db=nlebk&AN=783528|zOnline eBook via EBSCO. Access restricted to current Rider University students, faculty, and staff. 856 42 |3Instructions for reading/downloading the EBSCO version of this eBook|uhttp://guides.rider.edu/ebooks/ebsco 901 MARCIVE 20231220 948 |d20190118|cEBSCO|tEBSCOebooksacademic NEW 1-11-19 6702 |lridw 994 92|bRID