[Evaluating the safety with reference to intravenous tolerance of immunoglobulins].
The section 'Plasmatic Blood Constituents' of DGTI (German Society for Transfusion Medicine and Immunohematology) performed four ACA (anticomplementary activity) ring tests with human immunoglobulins for intravenous application (IVIG). The laboratories carrying out the analyses presented relatively consistent ACA results for IVIG commercial preparations that were obtained by means of the ACA method elaborated based on these tests. The tolerance trials evaluating the IVIGs solely by means of in vitro tests are not sufficient to serve as safety controls since there is no clear correlation existing between the ACA values and their compatibility in the animal model (rat).
Kotitschke
R
R
Biotest Pharma GmbH, Dreieichenhain, BRD.
Harbauer
G
G
D000818:Animals; D003169:Complement Inactivator Proteins; D007116:Immunization, Passive; D008297:Male; D011786:Quality Control; D051381:Rats; D011917:Rats, Inbred Lew
D003169:Complement Inactivator Proteins
Sicherheitsprüfungen zur intravenösen Verträglichkeit von Immunoglobulinen.