Een FDA doc uit 2015 over virus shedding …

Hoezo het bestaat niet …

Even een inhoudsopgave van het hele document ( vraag me en ik mail hem )

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products

Guidance for Industry

Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm.

For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above.

U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research August 2015

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