Openness and transparency are important considerations for medicines regulators, where public health is of paramount concern. As part of their commitment to transparency, the European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) in Australia publish information relating to their evaluation of medicines via public assessment reports. European Public Assessment Reports (EPARs) and Australian Public Assessment Reports (AusPARs) provide information about the considerations that led the regulator to approve or refuse the application. The reports summarise assessments by each regulator of the information provided on the quality, safety, and efficacy of the medicine under evaluation. Here, we describe the experiences of two established medicines regulators in publishing public assessment reports, and reflect on their future role in communicating medicines information.
1. Urinary cyclic nucleotide excretion was studied in 51 patients with malignant tumours and in 24 control subjects. 2. Adenosine 3':5'-cyclic monophosphate excretion was normal in patients with tumours. 3. Urinary excretion of guanosine 3':5'-cyclic monophosphate was significantly greater than normal in patients with lymphoid tumours (both sexes) and in male patients with myeloid tumours or malignant melanoma. 4. Guanosine 3':5'-cyclic monophosphate excretion was normal in patients with breast carcinoma or colonic adenocarcinoma.
Summary NK cells from three donors with a NK (CD3 -CD56 " CD 16 ") lymphoeytosis of unknown aetiology showed differential expression of CD45R0, an isoform of CD45 not expressed by NK cells from normal donors unless stimulated to proliferate in vitro. For donor FC, 60% of NK cells expressed CD45R0 over a 16 month period during which there was a partial resolution of the NK lymphoeytosis. For donor SW, 37% of NK cells expressed CD45R0. increasing to 87% over a 14 month period during which the NK lymphoeytosis increased. For donor RN few if any NK cells expressed CD45R0. After in vitro proliferation, 100% of NK cells generated from all donors expressed CD45R0. For donors FC and SW, CD45R0 remained expressed on more than 90% of cells at 3-4 weeks following eessation of proliferation. By contrast CD45R0 expression was gradually lost during long-term culture of NK cells from donor RN, with 58% of NK cells regaining the pre-culture CD45R0-phenotype. NK cells from normal donors also varied in the extent to which activation acquired CD45R0 was lost during long-term culture. The results obtained are consistent with the notion that NK eells from the NK lymphoeytosis donors studied have previously undergone proliferation in vivo.
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