Search Results for Drug ApprovalSirsiDynix Enterprisehttps://katalog.hacettepe.edu.tr/client/en_US/default/default/qu$003dDrug$002bApproval$0026ic$003dtrue$0026ps$003d300$0026isd$003dtrue?2024-11-01T12:59:34ZNew drug approval processent://SD_ILS/0/SD_ILS:2870902024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Guarino, Richard A., 1935-<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420088502">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>New drug approval processent://SD_ILS/0/SD_ILS:492142024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Guarino, Richard A. ed.<br/>Preferred Shelf Number QV 704 DRU 1993 C.56 1.K<br/>Format: Books<br/>Availability Health Sciences Library~1<br/>Anticancer drug development guide : preclinical screening, clinical trials, and approvalent://SD_ILS/0/SD_ILS:1120862024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Teicher, Beverly A., 1952- Andrews, Paul A.<br/>Preferred Shelf Number QV 269 A6295 2004<br/>Format: Books<br/>Availability Health Sciences Library~2<br/>Nano Drug Delivery for Cancer Therapy Principles and Practicesent://SD_ILS/0/SD_ILS:5221672024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Khan, Firdos Alam. editor. SpringerLink (Online service)<br/>Preferred Shelf Number XX(522167.1)<br/>Electronic Access <a href="https://doi.org/10.1007/978-981-99-6940-1">https://doi.org/10.1007/978-981-99-6940-1</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>FDA's drug review process and the package label : strategies for writing successful FDA submissionsent://SD_ILS/0/SD_ILS:4599122024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Brody, Tom, author.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access ScienceDirect <a href="https://www.sciencedirect.com/science/book/9780128146477">https://www.sciencedirect.com/science/book/9780128146477</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelinesent://SD_ILS/0/SD_ILS:4587992024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Brody, Tom, author.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access ScienceDirect <a href="http://www.sciencedirect.com/science/book/9780128042175">http://www.sciencedirect.com/science/book/9780128042175</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Generic drug product development solid oral dosage formsent://SD_ILS/0/SD_ILS:3428462024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Shargel, Leon, 1941- Kanfer, Isadore.<br/>Preferred Shelf Number ONLINE(342846.1)<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420086362">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Design and analysis of bridging studiesent://SD_ILS/0/SD_ILS:2852822024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Hsiao, Chin-Fu, 1964- Liu, Jen-pei, 1952- Chow, Shein-Chung, 1955-<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781439846353">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Clinical trials study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelinesent://SD_ILS/0/SD_ILS:1488332024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Brody, Tom.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access ScienceDirect <a href="http://www.sciencedirect.com/science/book/9780123919113">An electronic book accessible through the World Wide Web; click for information</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Pediatric nonclinical drug testing principles, requirements, and practicesent://SD_ILS/0/SD_ILS:2990962024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Hoberman, Alan M. Lewis, Elise M.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://lib.myilibrary.com/detail.asp?ID=362025">Connect to MyiLibrary resource</a>
Wiley InterScience <a href="http://dx.doi.org/10.1002/9781118168226">An electronic book accessible through the World Wide Web; click for information</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Safety pharmacology in pharmaceutical development approval and post marketing surveillanceent://SD_ILS/0/SD_ILS:2871242024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Gad, Shayne C., 1948- Gad, Shayne C., 1948- Safety pharmacology in pharmaceutical development and approval.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781439845684">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Pharmaceutical lifecycle management making the most of each and every brandent://SD_ILS/0/SD_ILS:2992432024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Ellery, Tony. Hansen, Neal. Wiley InterScience (Online service)<br/>Preferred Shelf Number ONLINE<br/>Electronic Access Wiley InterScience <a href="http://dx.doi.org/10.1002/9781118266755">An electronic book accessible through the World Wide Web; click for information</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>A clinical trials manual from the Duke Clinical Research Institute lessons from a horse named Jiment://SD_ILS/0/SD_ILS:3044072024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Liu, Margaret B. Davis, Kate (Kate G.) Liu, Margaret B. Lessons from a horse named Jim. Duke Clinical Research Institute. Wiley InterScience (Online service)<br/>Preferred Shelf Number ONLINE<br/>Electronic Access Contributor biographical information <a href="http://catdir.loc.gov/catdir/enhancements/fy0917/2009020427-b.html">http://catdir.loc.gov/catdir/enhancements/fy0917/2009020427-b.html</a>
John Wiley <a href="http://dx.doi.org/10.1002/9781444315219">http://dx.doi.org/10.1002/9781444315219</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Early drug development strategies and routes to first-in-human trialsent://SD_ILS/0/SD_ILS:2980042024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Cayen, Mitchell N.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access Wiley InterScience <a href="http://dx.doi.org/10.1002/9780470613191">An electronic book accessible through the World Wide Web; click for information</a>
<a href="http://lib.myilibrary.com?id=422895">Connect to MyiLibrary resource.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Reputation and power : organizational image and pharmaceutical regulation at the FDAent://SD_ILS/0/SD_ILS:3749122024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Carpenter, Daniel P., 1967- author.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://www.jstor.org/stable/10.2307/j.ctt7t5st">http://www.jstor.org/stable/10.2307/j.ctt7t5st</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Guidebook for drug regulatory submissionsent://SD_ILS/0/SD_ILS:2977182024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Weinberg, Sandy, 1950-<br/>Preferred Shelf Number ONLINE<br/>Electronic Access John Wiley <a href="http://dx.doi.org/10.1002/9780470456187">http://dx.doi.org/10.1002/9780470456187</a>
MyiLibrary, Table of contents <a href="http://www.myilibrary.com?id=202803&ref=toc">http://www.myilibrary.com?id=202803&ref=toc</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>The textbook of pharmaceutical medicineent://SD_ILS/0/SD_ILS:3044892024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Griffin, J. P. (John Parry) Wiley InterScience (Online service)<br/>Preferred Shelf Number ONLINE<br/>Electronic Access Ebook Library <a href="http://public.eblib.com/EBLPublic/PublicView.do?ptiID=470546">http://public.eblib.com/EBLPublic/PublicView.do?ptiID=470546</a>
John Wiley <a href="http://dx.doi.org/10.1002/9781444317800">http://dx.doi.org/10.1002/9781444317800</a>
Contributor biographical information <a href="http://catdir.loc.gov/catdir/enhancements/fy0917/2009024878-b.html">http://catdir.loc.gov/catdir/enhancements/fy0917/2009024878-b.html</a>
MyiLibrary, Table of contents <a href="http://www.myilibrary.com?id=238514&ref=toc">http://www.myilibrary.com?id=238514&ref=toc</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Pharmaceutical pre-approval inspections a guide to regulatory successent://SD_ILS/0/SD_ILS:2848832024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Hynes, Martin D.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420020489">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Development and approval of combination products a regulatory perspectiveent://SD_ILS/0/SD_ILS:2973632024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Siegel, Evan B.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access John Wiley <a href="http://dx.doi.org/10.1002/9780470371077">http://dx.doi.org/10.1002/9780470371077</a>
Contributor biographical information <a href="http://catdir.loc.gov/catdir/enhancements/fy0833/2008001360-b.html">http://catdir.loc.gov/catdir/enhancements/fy0833/2008001360-b.html</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>The pharmaceutical regulatory processent://SD_ILS/0/SD_ILS:2879182024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Berry, Ira R., 1942- Martin, Robert P. (Robert Paul)<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420070439">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Statistical thinking for non-statisticians in drug regulationent://SD_ILS/0/SD_ILS:3031732024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Kay, R. (Richard), 1949-<br/>Preferred Shelf Number ONLINE<br/>Electronic Access Wiley InterScience <a href="http://dx.doi.org/10.1002/9781118451885">An electronic book accessible through the World Wide Web; click for information</a>
Contributor biographical information <a href="http://catdir.loc.gov/catdir/enhancements/fy0806/2007022438-b.html">http://catdir.loc.gov/catdir/enhancements/fy0806/2007022438-b.html</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Core concepts in pharmacologyent://SD_ILS/0/SD_ILS:1103782024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Holland, Leland Norman, 1957- Adams, Michael, 1951-<br/>Preferred Shelf Number QV 39 H736 2007<br/>Format: Books<br/>Availability Health Sciences Library~2<br/>Handbook of pharmaceutical public policyent://SD_ILS/0/SD_ILS:2914662024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Fulda, Thomas R. Wertheimer, Albert I.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781439804261">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Good manufacturing practices for pharmaceuticalsent://SD_ILS/0/SD_ILS:2894502024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Nally, Joseph D.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420020939">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Multiple sclerosis therapeuticsent://SD_ILS/0/SD_ILS:1145812024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Cohen, Jeffrey A. (Jeffrey Alan). Rudick, Richard A.<br/>Preferred Shelf Number WL 360 M9619 2007<br/>Format: Books<br/>Availability Health Sciences Library~1<br/>Computer applications in pharmaceutical research and developmentent://SD_ILS/0/SD_ILS:2958292024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Ekins, Sean.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access John Wiley <a href="http://dx.doi.org/10.1002/0470037237">http://dx.doi.org/10.1002/0470037237</a>
<a href="http://www3.interscience.wiley.com/cgi-bin/homepage/?isbn=9780470037232">http://www3.interscience.wiley.com/cgi-bin/homepage/?isbn=9780470037232</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Generic drug product development : solid oral dosage formsent://SD_ILS/0/SD_ILS:1100422024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Shargel, Leon, 1941- Kanfer, Isadore.<br/>Preferred Shelf Number QV 704 D8426 2005<br/>Format: Books<br/>Availability Health Sciences Library~1<br/>Sustained-release injectable productsent://SD_ILS/0/SD_ILS:2894552024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Senior, Judith, editor. Radomsky, Michael, editor.<br/>Preferred Shelf Number ONLINE<br/>Electronic Access <a href="http://marc.crcnetbase.com/isbn/9781420026085">Distributed by publisher. Purchase or institutional license may be required for access.</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>Contested ground : public purpose and private interest in the regulation of prescription drugsent://SD_ILS/0/SD_ILS:923212024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Davis, Peter, ed.<br/>Preferred Shelf Number QV 736 C761 1996<br/>Format: Books<br/>Availability Health Sciences Library~1<br/>Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting, and product registrationent://SD_ILS/0/SD_ILS:3007692024-11-01T12:59:34Z2024-11-01T12:59:34ZAuthor Gregersen, Jens-Peter. Wiley InterScience (Online service)<br/>Preferred Shelf Number ONLINE<br/>Electronic Access John Wiley <a href="http://dx.doi.org/10.1002/9783527615834">http://dx.doi.org/10.1002/9783527615834</a><br/>Format: Electronic Resources<br/>Availability Online Library~1<br/>