Regulatory - links to organizations and guidances

Drug Delivery Related Regulatory Guidances

1. FDA Oral controlled release SUPAC guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM070640.pdf

2. FDA liposomal drug products CMC guidance:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm070570.pdf

3. Extended Release, Oral dosage forms: IVIVC  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM070239.pdf

4. Residual drug in Transdermal and related delivery systems
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM220796.pdf

5. Nasal and Inhalation Formulations CMC
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm070575.pdf

6. MDI and DPI CMC
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm070573.pdf

7. Drug Eluting Stents – Nonclinical & Clinical Studies
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM228705.pdf

8. WHO Pharmaceutical development of generics http://www.who.int/medicines/services/expertcommittees/pharmprep/
PharmDevelGener_QAS08_251_11012008.pdf

Product Development Links

1. Inactive ingredients guide to approved materials:  http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

2. Interspecies differences:  http://www.rivm.nl/interspeciesinfo/about/

3. Drug bank physical chemistry information on 4800 approved FDA small molecules:  http://www.drugbank.ca/

4. General DMPK/Tox information:
http://medicine.iupui.edu/clinpharm/ddis/table.asp (P450 Interactions)

5. US Pharmacopeia http://www.usp.org/

6. British Pharmacopeia http://www.pharmacopoeia.co.uk/

7. European Pharmacopeia http://www.edqm.eu

8. Chinese Pharmacopeia http://www.chp.org.cn/

9. International Pharmacopeia http://www.who.int/medicines/publications/pharmacopoeia/overview/en/

Related Organizations

NIH Tranlational Research site
http://commonfund.nih.gov/clinicalresearch/overview-translational.aspx

National Cancer Institute Nanotechnology Characterization Lab
http://nci.cancer.gov

FDA Nanotechnology Task Force  http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/
NanotechnologyTaskForce/default.htm

International Pharmaceutical Aerosol Consortium on Regulation and Science  www.ipacrs.com

European Federation of Pharmaceutical Industries Associations (EFPIA)  www.efpia.org

IPEC Americas http://ipecamericas.org/