Regulatory control and standardization of allergenic extracts. Bd. 93 (Frankfurt am Main, 2000) - ОГЛАВЛЕНИЕ / CONTENTS
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ОбложкаRegulatory control and standardization of allergenic extracts. 9th International Paul-Ehrlich-Seminar, September 9-11, 1999. Bd. 93 / ed. by Reinhard K., Dieter H., Reinhard K. - Frankfurt am Main: GIT Verlag, 2000. - ISBN 3-928865-30-7
 

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Оглавление / Contents
 
Welcome Address to the 9th International
Paul-Ehrlich-Seminar
   D. Haustein	 ................................................ 1

Current State of Regulation
   Chairmen: M.R. Rooke, H. Rode ................................ 5

Adaptation of registration dossiers to the requirements of
the Directive 89/342/EEC (so-called „Updating")
   G. Höltz ..................................................... 7
Discussion ..................................................... 11

The European guidelines regulating allergen products and the
Ph.Eur. Monograph on Allergens: transformation into everyday
practice
   W. Geißler .................................................. 13
Discussion ..................................................... 17

Round-Table-Discussion:Allergen regulation in European
Countries
   M.C.Annequin, J. Dayan-Kenigsberg, K. Erlandsson-Persson,
   L.J. Husager, O.A. Lake, S. May, S. Mäkinen-Kiljunen,
   С. Pini, Т. Schneider ....................................... 21

Status of allergen standardization in India
   B.Р. Singh .................................................. 41
Discussion ..................................................... 45

Statistical consideration in the establishment of release
limits for allergen vaccines in the USA
   J. Slater et al. ............................................ 47
Discussion ..................................................... 56

Formulation of therapeutic allergen mixtures: problems
associated with the number, proportion and enzymatic
activities of allergens
   R.E. Esch ................................................... 57

Named patient products: interest and possible regulation
   A.Saporta ................................................... 63

Named patient products: critical aspects
   H.J.Malling.................................................. 67

Round-Table-Discussion:Allergen mixtures/named patient
products
   R.E. Esch, A. Saporta, H.J. Mailing ......................... 73

Standardization and Quality Control of Allergen Products
   Chairmen: W.M. Becker, S. Vieths ............................ 79

Quality improvements of allergenic source material
   С. Bergquist ................................................ 81
Discussion ..................................................... 86

A new start for allergen references and standardization based
on purified/ recombinant allergens and monoclonal and
monospecific polyclonal antibodies
   R. van Rее .................................................. 87
Discussion ..................................................... 90

Standardization in quality control of modified end-products
   0. Cromwell et al. .......................................... 93
Discussion .................................................... 100

Assays for the determination of the biological activity of
allergen extracts
   A. Hoffmann et al. ......................................... 101
Discussion .................................................... 108

Problems of food allergen extracts
   S. Lehrer and G. Reese ..................................... 111
Discussion .................................................... 116

Clinical Trials with New and Established Allergen Products
   Chairmen: K.Ch. Bergmann, H.J. Mailing ..................... 119

Local routes of immunotherapy
   J. Bousquet ................................................ 121
Discussion .................................................... 128

A clinical trial with purified natural major allergens from
grass pollen
   M. Fernández-Rivas et al. .................................. 131
Discussion .................................................... 136

Vaccination strategies in young children at risk for allergy
   K. Duchén .................................................. 239
Discussion .................................................... 142

Requirements for demonstrating clinical efficacy: clinical
aspects
   T.R. Kordash ............................................... 145

Requirements for demonstrating clinical efficacy:
statistical aspects
   W. Lehmacher ............................................... 149
Discussion .................................................... 154

Recombinant versus Natural Allergens
   Chairmen: D. Kraft, K. Blaser .............................. 157

Recombinant allergens expressed in E. coli: benefits and
drawbacks in the diagnosis of food allergies
   S.Vieths et al. ............................................ 159
Discussion .................................................... 169

Cloning and characterization of Phi p I in different
expression systems
   W.M. Becker et al. ......................................... 171
Discussion .................................................... 179

Expression of yellow-jacket and wasp venom Ag5 allergens in
bacteria and in yeast
   R. Monsalve et al. ......................................... 181
Discussion .................................................... 188

Biological activity of recombinant bee venom allergens and
their mutants expressed in baculovirus-infected cells
   L. Soldatova ............................................... 189
Discussion .................................................... 194

Structural and biological demands on recombinant allergens
related to their application
   M. Spangfort ............................................... 197
Discussion .................................................... 201

Skin testing with wild-type recombinant birch pollen
allergens and hypoallergenic modified molecules
   G.Pauli et al. ............................................. 203
Discussion .................................................... 210

Large scale production and quality criteria of recombinant
allergens for marketing
   R. Valenta et al. .......................................... 211
Discussion .................................................... 224

Registration of recombinant proteins (including allergens)
in the EU
   C.Pini ..................................................... 227
Discussion .................................................... 230

Expression and cloning of recombinant indoor allergens
   M. Chapman ................................................. 233
Discussion .................................................... 238


 
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