Clinical Development Plan for Hepatitis B Treatment

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Essay #: 057379
Total text length is 15,215 characters (approximately 10.5 pages).

Excerpts from the Paper

The beginning:
Clinical Development Plan for Hepatitis B Treatment: NZMS-202 Hepviva
COMPOUND OVERVIEW
Target Compound: NZMS-202
Trade Name:
Hepviva
Generic Name:
Trantipadine
Therapeutic Area: Infectious Disease
Indication: Hepatitis B
Dosing: 50 mg coated tablet
Administration: Oral tablet
Monotherapy
or Combo Therapy:
Monotherapy
and in combination w/
other
Antivirals
Drug or Biologic: Nucleoside analog reverse transcriptase
inhibitor (NRTI) antiviral
Current Stage of Development: 30 days post-IND submission to FDA
Table of Contents
Section 1: Project Overview
Section 2: Communication Plan
Section 3: Project Timeline
Section 4: Non-Clinical Plan
Section 5:Clinical Trials Overview
Section 6:Data Management Plan
Section 7:Regulatory Strategy
Section...
The end:
.....marked%20Practice%20Guidelines/Chronic_Hep_B_Update_2009%208_24_2009.pdf.
Marcellin
, P., Lau, G.K.,
Bonino
, F.,
Farci
, P.,
Hadziyannis
,
S., Jin, R., et al. (2004).
Peginterferon
alfa-2a alone,
lamivudine
alone, and the two in combination in patients with
HBeAg
-negative chronic hepatitis B. New England Journal of Medicine, 351(12): 1206 - 1217.
National Institutes of Health. (2010). Hepatitis B. Medline Plus
Website. Last updated January 2010. Retrieved February 1, 2010, http://www.nlm.nih.gov/medlineplus/hepatitisb.html.
National Institutes of Health. (2010b). Understanding clinical
trials. ClinicalTrials.gov Website. Lasted updated September 20, 2007. Retrieved February 10, 2010, from http://clinicaltrials.gov/ct2/info/understand#Q20.