Biomedical Engineering Reference
In-Depth Information
References
1. Black LE, Bendele AM, Bendele RA, Zack PM,
Hamilton M (1999) Regulatory decision strat-
egy for entry of a novel biological therapeutic
with a clinically unmonitorable toxicity into
clinical trials: pre-IND meetings and a case
example. Toxicol Pathol 27(1):22-26
2. Food and Drug Administration Website.
Drugs @FDA: ( http://www.accessdata.fda.
gov/scripts/cder/drugsatfda/index.cfm )
3. European Medicines Agency Website. Human
medicines: ( http://www.ema.europa.eu/ema/
index.jsp?curl
system in patients with persistent macular
edema. Arch Ophthalmol 125(3):309-317
14. Demill DL, Wirostko BM, Nelson LA, Stewart
JA, Stewart WC (2013) Average versus highest
intraocular pressure analyses in glaucoma clini-
cal trials. Ophthalmic Res 49(1):49-51
15. Miglior S, Bertuzzi F (2013) Relationship
between intraocular pressure and glaucoma
onset and progression. Curr Opin Pharmacol
13(1):32-35
16. European Medicines Agency (2012) Docu-
ment EMA/450332/2012. EU Regulatory
Workshop—Ophthalmology—Summary and
Report: Clinical Development, Scientific
Advice and Paediatric Investigation Plans
17. McLeod LD, Coon CD, Martin SA, Fehnel SE,
Hays RD (2011) Interpreting patient-reported
outcome results: US FDA guidance and
emerging methods. Expert Rev Pharmacoecon
Outcomes Res 11(2):163-169
18. Vandenbroeck S, De Geest S, Zeyen T, Stal-
mans I, Dobbels F (2011) Patient-reported
outcomes (PRO's) in glaucoma: a systematic
review. Eye (Lond) 25(5):555-577
19. Food and Drug Administration Website. New
drug application. ( http://www.fda.gov/
Drugs/ DevelopmentApprovalProcess/How
DrugsareDevelopedandApproved/Approva
lApplications/NewDrugApplicationNDA/
default.htm )
20. International Conference on Harmonisation
Website. Common technical document
( http://www.ich.org/products/ctd.html )
21. Food and Drug Administration Website.
Approval process ( http://www.fda.gov/Drugs/
ResourcesForYou/Consumers/ucm289601.
htm#review )
22. Food and Drug Administration Website.
Advisory committees ( http://www.fda.gov/
AdvisoryCommittees/default.htm )
23. Food and Drug Administration Website.
Review process overview ( http://www.fda.
gov/Drugs/ResourcesForYou/Consumers/
ucm143534.htm )
24. Congressional Research Service (2001) CRS
report for congress. The U.S. drug approval
process: a primer
25. Food and Drug Administration Website. Fast
Track, Accelerated Approval and Priority
Review ( http://www.fda.gov/ForConsumers/
ByAudience/ForPatientAdvocates/Speeding
AccesstoImportantNewTherapies/
ucm128291.htm )
26. Marchand HC, Ros BJ, Fine AM, Kremzner
ME (2012) The U.S. Food and drug
pages/regulation/landing/
human_medicines_regulatory.jsp&mid
¼
¼
WC0b01ac058001ff89)
4. Kohler M (2011) Regulatory pathways in the
European Union. MAbs 3(3):241-242
5. International Conference on Harmonisation
Website ( http://www.ich.org/ )
6. Food and Drug Administration Website. Inves-
tigational new drug application ( http://www.
fda.gov/drugs/developmentapprovalprocess/
howdrugsaredevelopedandapproved/approva-
lapplications/investigationalnewdrugindappli-
cation/default.htm )
7. European Medicines Agency (2009) Docu-
ment CPMP/ICH/286/95: Note for guid-
ance on non-clinical safety studies for the
conduct of human clinical trials and marketing
authorization for pharmaceuticals
8. Investigational Medicinal Product Dossier
Website ( http://www.impd.eu/ )
9. International Conference on Harmonisation
Website. Safety guidelines ( http://www.ich.
org/products/guidelines/safety/article/safety-
guidelines.html
10. Food and Drug Administration Website. Drug
Development and Review Definitions ( http://
www.fda.gov/Drugs/DevelopmentApproval
Process/HowDrugsareDevelopedandApp
roved/ApprovalApplications/Investigational
NewDrugINDApplication/ucm176522.htm )
11. European Medicines Agency (1998) Docu-
ment CPMP/ICH/291/95: Note for guid-
ance on general consideration for clinical trials
12. Food and Drug Administration, Center for
Drug Evaluation and Research (2009) Guid-
ance for industry: End of phase 2A meetings.
Available at: http://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM079690.pdf .
Accessed on 18 January 2013
13. Kuppermann BD, Blumenkranz MS, Haller JA
et al (2007) Randomized controlled study of
an intravitreous dexamethasone drug delivery
Search WWH ::




Custom Search