-
1
-
-
85015863523
-
-
Parenteral Drug Association
-
Khan, A. S.; King, K.E.; Brack, K.; Cassart, J-P.; Chiu, C.; Dehghani, H.; Duncan, P.; Jaing, C.; Kolman, J.; Munroe, D.; Palermo, A.; Plavsic, M.; Sampath, R.; Slezak, T,; Takle, G.; Taliaferro, L.P.; Toso, E., Vacante, D., Willkommen, H. et al. Emerging Methods for Virus Detection, Technical Report No. 71. Parenteral Drug Association, 2015.
-
(2015)
Emerging Methods for Virus Detection, Technical Report No. 71
-
-
Khan, A.S.1
King, K.E.2
Brack, K.3
Cassart, J.-P.4
Chiu, C.5
Dehghani, H.6
Duncan, P.7
Jaing, C.8
Kolman, J.9
Munroe, D.10
Palermo, A.11
Plavsic, M.12
Sampath, R.13
Slezak, T.14
Takle, G.15
Taliaferro, L.P.16
Toso, E.17
Vacante, D.18
Willkommen, H.19
-
2
-
-
78149314727
-
Quality guideline Q5A(R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
-
accessed April 23, 2016
-
Quality Guideline Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; International Conference on Harmonisation: 1999, www. ich.org (accessed April 23, 2016).
-
(1999)
International Conference on Harmonisation
-
-
-
3
-
-
85015820298
-
Guidance for industry: Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications
-
accessed April 23, 2016
-
Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; U.S. Food and Drug Administration, 2010, http://www. fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf (accessed April 23, 2016).
-
(2010)
U.S. Food and Drug Administration
-
-
-
5
-
-
78149286255
-
Quality guideline Q5D: Derivation and characterisation of cell substrates used for production of biotechnological/biological products
-
accessed April 23, 2016
-
Quality Guideline Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products; International Conference on Harmonisation, 1998, http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003280.pdf (accessed April 23, 2016).
-
(1998)
International Conference on Harmonisation
-
-
-
6
-
-
78149344560
-
Testing considerations for novel cell substrates: A regulatory perspective
-
Khan, A. S. Testing Considerations for Novel Cell Substrates: A Regulatory Perspective. PDA J. Pharm. Sci. Technol. 2010, 64 (5), 426-431.
-
(2010)
PDA J. Pharm. Sci. Technol.
, vol.64
, Issue.5
, pp. 426-431
-
-
Khan, A.S.1
-
7
-
-
77952692589
-
Viral nucleic acids in live-attenuated vaccines: Detection of minority variants and an adventitious virus
-
Victoria, J.; Wang, C.; Jones, M. S.; Jaing, C.; McLoughlin, K.; Gardner, S.; Delwart, E. L. Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of Minority Variants and an Adventitious Virus. J. Virol. 2010, 84 (12), 6033-6040.
-
(2010)
J. Virol.
, vol.84
, Issue.12
, pp. 6033-6040
-
-
Victoria, J.1
Wang, C.2
Jones, M.S.3
Jaing, C.4
McLoughlin, K.5
Gardner, S.6
Delwart, E.L.7
-
8
-
-
85015909430
-
2012 meeting materials: Vaccines and related biological products advisory committee
-
accessed April 23, 2016
-
2012 Meeting Materials: Vaccines and Related Biological Products Advisory Committee; U.S. Food and Drug Administration, 2012, http://www.fda. gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/vaccinesandrelatedbiologicalproductsadvisorycommittee/ucm288695.htm, (accessed April 23, 2016).
-
(2012)
U.S. Food and Drug Administration
-
-
-
9
-
-
84858081225
-
Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD
-
Sheets, R.; Loewer, J.; Raychaudhuri, G.; Petricciani, J. Adventitious Agents, New Technology, and Risk Assessment, 19-20 May 2011, Baltimore, MD. Biologicals 2012, 40 (2), 162-167.
-
(2012)
Biologicals
, vol.40
, Issue.2
, pp. 162-167
-
-
Sheets, R.1
Loewer, J.2
Raychaudhuri, G.3
Petricciani, J.4
-
10
-
-
84873643152
-
PDA/FDA adventitious agents and novel cell substrates: Emerging technologies and new challenges, November 2-4, 2011, Rockville, MD
-
Khan, A.; Lubiniecki, A.; King, K. E. PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, November 2-4, 2011, Rockville, MD. PDA J. Pharm. Sci. Technol. 2012, 66 (6), 502-511.
-
(2012)
PDA J. Pharm. Sci. Technol.
, vol.66
, Issue.6
, pp. 502-511
-
-
Khan, A.1
Lubiniecki, A.2
King, K.E.3
-
11
-
-
84915787947
-
Introduction and workshop summary: PDA/FDA advanced technologies for virus detection in the evaluation of biologicals: Applications and challenges
-
Khan, A.; Vacante, D. A. Introduction and Workshop Summary: PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals: Applications and Challenges. PDA J. Pharm. Sci. Technol. 2014, 68 (6), 546-547.
-
(2014)
PDA J. Pharm. Sci. Technol.
, vol.68
, Issue.6
, pp. 546-547
-
-
Khan, A.1
Vacante, D.A.2
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