J E Slater
Affiliation: Food and Drug Administration
- The US Food and Drug Administration review of the safety and effectiveness of nonstandardized allergen extractsJay E Slater
US Food and Drug Administration, Rockville, MD, USA
J Allergy Clin Immunol 129:1014-9. 2012..Two external panels deliberated, the first from 1974-1979 and the second from 1982-1983...
- Biological potency of German cockroach allergen extracts determined in an inner city populationJ E Slater
Center for Biologics Evaluation and Research, U S Food and Drug Administration, Bethesda, MD, USA
Clin Exp Allergy 37:1033-9. 2007..To perform valid studies on the diagnosis and treatment of cockroach allergy, biological potencies of test extracts need to be established, and a surrogate in vitro test for biological potency should be chosen...
- Competition enzyme-linked immunosorbant assay (ELISA) can be a sensitive method for the specific detection of small quantities of allergen in a complex mixtureE Dobrovolskaia
Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20852, USA
Clin Exp Allergy 36:525-30. 2006..This study was designed to determine the sensitivity of the competition ELISA to detect the specific loss of Bla g 1 and Bla g 2 in cockroach extracts...
- Characterization of allergen extractsJ E Slater
Laboratory of Immunobiochemistry, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Regulation and Research, CBER USFDA, Bethesda, MD, USA
Dev Biol (Basel) 122:145-52. 2005..The surrogate tests differ for different extracts. National reference standards to which manufactured lots are compared are maintained at FDA/CBER. Allergen standardization has facilitated the establishment of data-driven release limits...
- Characterization and comparison of commercially available German and American cockroach allergen extractsM L Patterson
Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Bethesda 20852, USA
Clin Exp Allergy 32:721-7. 2002..In this study we examine the variability among unstandardized cockroach allergen extracts...
- Exploiting the avian immunoglobulin system to simplify the generation of recombinant antibodies to allergenic proteinsW J J Finlay
Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA
Clin Exp Allergy 35:1040-8. 2005..Therefore, we have examined recombinant antibody development by phage-display against single allergens and protein mixtures...
- Specific monoclonal antibodies and human immunoglobulin E show that Hev b 5 is an abundant allergen in high protein powdered latex glovesM F Sutherland
Department of Allergy, Asthma and Clinical Immunology, The Alfred Hospital and Monash University, Victoria, Australia
Clin Exp Allergy 32:583-9. 2002..Moreover, standardized immunological assays for the detection of Hev b 5 are currently lacking and may have important implications for both allergen avoidance and diagnosis in latex allergy...