Guidance for submitting HBV resistance data
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is guidance for submitting hepatitis B virus (HBV) resistance data. Sponsors are encouraged to use the presented sample format. One dataset combines patient, endpoint, genotypic and phenotypic data. This paper offers recommendations for constructing datasets and information to be included with suggested column headings.
| Published: | 2006 |
| Format: | |
| Length: | 4 pages |
| Type: | White paper |
| Language: | English |
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