WHO Expert Committee on Biological Standardization
INDEXCONTENTS General..................................... substances Antibiotics 1. Streptomycin ...................... 2. Amikacin ......................... 3. Sisomicin.......................... 4. Tobramycin ....................... 5. Bleomycin (bleomycin complexA2/B2) 6. Bleomycin A5...................... Antibodies 7. Anti-toxoplasma serum, human ...... 8. Clostridium botulinum type B antitoxin 9. Antivenoms ....................... Antigens 10. Purified protein derivative (PPD) of bovine tuberculin 11. Purified protein derivative (PPD) of mallein ......... 12. Clostridium botulinum type B toxin ................. 13. Diphtheria and tetanus toxoids for flocculation tests .. 14. Live Newcastle disease vaccines ................... 15. Tetanus toxin .................................... 16. Pertussis vaccine ................................. 17. Yellow fever vaccine.............................. Blood Products and Related Substances 18. Plasmin ......................................................... 19. Blood coagulation factor VIII in plasma ............................. 20. Anti-B blood typing serum, human ................................. 21. Anti-A, anti-A,B, anti-C complete, anti-D complete, and anti-E complete blood typing sera, human.......................................... 22. Blood group substances A and B ................................... 23. Human serum immunoglobulin E................................... 24. Anti-hepatitis A immunoglobulin................................... 25. Human serum complement components Clq, C4, C5, and factor B ..... 26. International reference preparation of haemiglobincyanide............. Endocrinologies! and Related Substances 27. Human growth hormone (HGH) ............................... 28. Corticotrophin, porcine ....................................... 29. Chorionic gonadotrophin, human............................... 30. Pituitary gonadotrophins FSH and LH (ICSH), human, for bioassay31. Follicle-stimulating hormone, pituitary, human, for immunoassay 32. Gonadotrophin-releasing hormone (gonadorelin) 33. Secretin .................................................. 34. Parathyroid hormone, human ............................... 35. Insulin ................................................... 36. Desmopressin............................................. Reference Reagents 37. Pyrogens ......................................... 38. Subtype specific antisera to hepatitis B surface antigens requirements for biological substances 39. Requirements for rabies vaccine for human use....................... 40. Requirements for rabies vaccine for veterinary use.................... 41. Requirements for hepatitis B vaccine ............................... 42. Requirements for poliomyelitis vaccine (oral) ........................ 43. Requirements for meningococcal polysaccharide vaccine............... 44. Requirements for thromboplastins and plasma used to control oral anticoagulant therapy ................................................ 45. Requirements for immunoassay kits ................................ 46. Guidelines for quality assessment of antitumour antibiotics ............ 47. Requirements for antibiotic susceptibility tests ....................... 48. The national control of vaccines and sera ............................ 49. Requirements for rubella vaccine (live).............................. 50. Requirements for diphtheria toxoid, pertussis vaccine, tetanus toxoid, and combined vaccines................................................ 51. WHO blood programme .......................................... Acknowledgements...................................................... annexes Annex 1. Procedure for approval by WHO of yellow fever vaccines in connexion with the issue of international vaccination certificates ............. Annex 2. Requirements for rabies vaccine for human use .................. Annex 3. Requirements for rabies vaccine for veterinary use ............... Annex 4. Requirements for hepatitis B vaccine ....................;...... Annex 5. Requirements for poliomyelitis vaccine (oral) (Addendum 1980) Annex 6. Requirements for meningococcal polysaccharide vaccine (Addendum 1980) .................................................. Annex 7. Requirements for thromboplastins and plasma used to control oral anticoagulant therapy......................................... Annex 8. Requirements for immunoassay kits ............................ Annex 9. Guidelines for quality assessment of antitumour antibiotics ........ Annex 10. Requirements for antibiotic susceptibility tests (Suggested changes 1980) ....................................................... Annex 11. The national control of vaccines and sera...... Annex 12. Requirements for rubella vaccine (live) (Addendum 1980) ........ Annex 13. Requirements for diphtheria toxoid, pertussis vaccine, tetanus toxoid, and combined vaccines (Addendum 1980)....................... Annex 14. Biological substances: international standards, reference preparations, and reference reagents........................................ Annex 15. Requirements for biological substances and other sets of recommendations .....................................................
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