doxercalciferol bioequivalence Pages on BioPortfolio:

What's New at CDER by Date
Hectorol (doxercalciferol) Capsules, Genzyme Corp., Control Supplement .... Guidance for Industry: Individual Product Bioequivalence Recommendations [HTML] ...
http://www.bioportfolio.co.uk/cgi-bin/htm_hl.pl?DB=search&ST...

Results from other life science and pharmaceutical sites:

Guidance for Industry: Individual Product Bioequivalence ...
Draft Guidance for Industry: Bioequivalence Recommendations for Specific Products (Issued May, ... Doxercalciferol, Draft, Oral, Capsule, 20862, 8/2008
...
http://www.fda.gov/Cder/Guidance/bioequivalence/default.htm...

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... .doxercalciferol. HELIDAC . . . . . . . . . . .bismuth, metronidozole, tetracycline ...... AA – Products not presenting bioequivalence problems in ...
http://www.watson.com/assets/brand_generic_reference.pdf...

New Drug Application (NDA) & Biologic License Application (BLA ...
doxercalciferol, Bone Care, 020862, SE1, 006, 12/27/01, 4/23/04, 27.9 ..... tablets to be bioequivalent and therapeutically equivalent to the listed drug
...
http://www.fda.gov/cder/rdmt/ESCY04AP.htm...

Watson 2007 Generic To Brand Reference Guide
doxercalciferol . ...... AA – Products not presenting bioequivalence problems in ... AB – Products meeting necessary bioequivalence requirements. ...
http://www.watson.com/assets/products/brand_generic_referenc...

1745-6215-8-22 1745-6215 Study protocol Comparison of total ...
The latter margin is the same as usually used for bioequivalence trials .... of intermittent intravenous and oral doxercalciferol (1alpha-hydroxyvitamin ...
http://www.biomedcentral.com/content/download/xml/1745-6215-...

CDER 1999 Report to the Nation
Doxercalciferol. (Hectorol). Entacapone (Comtan). Epirubicin hydrochloride ..... bioequivalence and none with CMC data prior to 1998. In continued ...
http://www.fda.gov/Cder/reports/rtn99.pdf...

Medicare Part D Manual
are not therapeutically equivalent and bioequivalent in each category and class .... Vitamin D analogs such as calcitriol, doxercalciferol, paricalcitol and ...
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/P...

Approved Drug Products with Therapeutic Equivalence Evaluations ...
bioequivalence problems, and for post-1962 drug products in a dosage ...... DOXERCALCIFEROL. CAPSULE; ORAL. HECTOROL. GENZYME. 0.5UGM. N20862 002 ...
http://www.fda.gov/cder/orange/obannual.pdf...

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