{"title":"The EAMG position on the regulation of existing products for treatment with special reference to named patient products (NPPs).","authors":"Albert M Kroon","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Allergen products have a long history in both diagnosis and management of allergic disease. It is emphasized that the availability of named patient products presents a valuable and indispensable option for the effective and safe treatment of patients suffering from IgE-mediated allergic diseases. A regulatory climate should be achieved in which these products can survive until a safe and effective alternative is borne out. Within the context of the paper the following definition is used: A named patient product or NPP is an allergen product, prepared with a specific reference number in accordance with a prescription for an individual patient, identified by the name of this patient and the reference number, and delivered after control of consistency with previous treatments. It is stressed that the standards of quality that hold for registered products are also applicable for named patient preparations which, for various reasons, can not be filed for registration. The paper frequently refers to a Position Paper that has recently been adopted by the European Allergen Manufacturers Group, the EAMG. The presentation breaks a lance for a concerted approach of the NPP-concept by striving at harmonization of legal, regulatory, manufacturing, and distribution conditions.</p>","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"7-14; discussion 14-6"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Peptide-based immunotherapy: new developments.","authors":"Mark Larché","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"133-9; discussion 139-40"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hypoallergenic variants of the Parietaria judaica major allergen Par j 1: in vitro and in vivo evaluation.","authors":"Paolo Colombo","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"198-203; discussion 204"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Engineering and validation of recombinant proteins for allergen vaccines.","authors":"Michael D Spangfort","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"151-4; discussion 155"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Barbara K Ballmer-Weber, Andrea Wangorsch, Stephan Scheurer
{"title":"Recombinant food allergens in the diagnosis of pollen-related food allergy.","authors":"Barbara K Ballmer-Weber, Andrea Wangorsch, Stephan Scheurer","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"192-6; discussion 197"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Alternative approaches to immunotherapy of allergy.","authors":"Irwin Ziment","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Alternative therapies for allergic diseases may be prescribed by physicians or provided by other practitioners or selected by patients without resorting to consultation with a health advisor. The most popular alternative therapies include dietary manipulation and exaggerated avoidance of allergens. Established medical therapies include herbs (Western and Asian), homeopathy and acupuncture; many publications suggest they are of value in allergic disease management. However, most studies lack sufficient power, do not have adequate controls, fail to duplicate standard clinical practices, or utilize a heterogeneous group of subjects. Careful analysis suggest that popular alternative therapies might offer a minimal benefit over placebos, but further studies are required for more rigorous evaluation of outcomes. Numerous esoteric or non-specific methods of treating allergic diseases are also available which may be promoted by enthusiastic practitioners or supported by satisfied patients. The majority of such therapies will never be scientifically evaluated, and the results of such modalities will be difficult to separate out from those of true placebo treatments. It is evident that while the \"prose\" of scientifically established therapies is appealing to a declining number of patients, the \"poetry\" of complementary therapies resonates with an increasing majority of the public who believe in the magic of alternative medicine.</p>","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"247-57; discussion 257-9"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Parallels between parasite infections and specific immunotherapy.","authors":"Ronald van Ree, Maria Yazdanbakhsh","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"260-3; discussion 263-6"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Oliver Cromwell, Helga Kahlert, Gabriele Schramm, Roland Suck, Andreas Nandy, Bernhard Weber, Helmut Fiebig
{"title":"Mechanisms of immunotherapy with allergoids: lessons for the development of recombinant allergens with reduced IgE-binding activity.","authors":"Oliver Cromwell, Helga Kahlert, Gabriele Schramm, Roland Suck, Andreas Nandy, Bernhard Weber, Helmut Fiebig","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"156-61; discussion 161-2"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496881","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Criteria for clinical efficacy--readout and monitoring of clinical studies.","authors":"Hans-Jørgen Malling","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"119-23; discussion 123-5"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Expression of allergens in E. coli and plants--benefits and drawbacks.","authors":"Heimo Breiteneder, Birgit Wagner","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recombinant allergens are quickly becoming the reagents of choice for diagnosis and therapy of type I allergic diseases. Consequently, the different methods for the production of recombinant proteins that are available today are of great interest to allergologists. Without doubt, bacterial expression will continue to play a pivotal role. In addition, plant-based expression systems will be needed to overcome problems inherent in the E. coli systems and to allow the production of glycoallergens or allergens of more complex folding.</p>","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"178-87"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}