Knight P A, Lucken R N
Dev Biol Stand. 1977;38:51-8.
The control of C. parvum suspension presents special problems. The intended application of this preparation is in a therapeutic area where clinicians are accustomed to using defined chemical entities the biological activity of which are usually predictable according to weight of active principle administered, the route and number of doses. But the essential character of C. parvum is that of a vaccine in which the character of the active principle or principles is not clearly identified and can vary according to certain conditions. The control of the preparation therefore depends on the nature and relevance of tests for biological activity. These problems are exacerbated by uncertainty as to which of several possible mechanisms of antitumour activity might prove relevant in clinical practice. Experience with these problems as they have affected the quality control of large numbers of batches of C. parvum suspension prepared for clinical trial, will be discussed.
微小隐孢子虫悬浮液的控制存在特殊问题。该制剂的预期应用领域是临床医生习惯使用特定化学实体的治疗领域，这些化学实体的生物活性通常可根据给药活性成分的重量、给药途径和剂量数量进行预测。但微小隐孢子虫的本质特征是一种疫苗，其中活性成分的特征尚未明确确定，并且可能因某些条件而有所不同。因此，制剂的控制取决于生物活性测试的性质和相关性。由于几种可能的抗肿瘤活性机制中哪一种可能在临床实践中具有相关性尚不确定，这些问题更加复杂。将讨论这些问题对为临床试验制备的大量微小隐孢子虫悬浮液批次质量控制的影响。
