Participation of patients in the development of advanced therapy medicinal products.

An increasing number of advanced therapy medicinal products (ATMPs) are under development and in clinical trials. Patients are central to this progress. In research, patients have funded, catalysed, coordinated and led projects. In regulation, patient groups have contributed to the creation of the political momentum for regulation of ATMPs, contributed to the debate and now participate in the regulatory process. Once licensed, patients will have a role in the pharmacovigilance, health technology assessment and reimbursement arrangements for these products. Patient groups contribute valuably as equal stakeholders at every step of the development of an ATMP.

Forecasting with growth curves: the effect of error structure.

"The main theme of this paper is an investigation into the importance of error structure as a determinant of the forecasting accuracy of the logistic model. The relationship between the variance of the disturbance term and forecasting accuracy is examined empirically. A general local logistic model is developed as a vehicle to be used in this investigation. Some brief comments are made on the assumptions about error structure, implicit or explicit, in the literature." The results suggest that "the variance of the disturbance term, when using the logistic to forecast human populations, is proportional to at least the square of population size."

A modified logistic model applied to human populations.

"The use of the logistic curve for forecasting human populations [in the United Kingdom] considered by Leach is re-examined. A modification of the use of the logistic curve is suggested, which changes the emphasis from fitting a logistic trend to providing a forecast logistic trend. The assumption, used by Leach, that the variance of the additive disturbance term is constant is replaced by a more realistic supposition that the variance of the proportional disturbance is constant. The forecasting performance of the modified logistic model is shown to be superior to that of the model used by Leach." A reply by Leach (pp. 496-7) and a response by the author (p. 498) are included.

Lectin-like activity from Persea americana.

An extract from the seeds of Persea americana possessed an erythro-agglutinating activity. The agglutinin was devoid of specificity for carbohydrates, but interacted readily with basic proteins or basic polyamino acids. The interaction between the agglutinin and egg-white lysozyme was not inhibited by chaotropic salts, but was sensitive to relatively low concentrations of urea. An affinity chromatographic procedure was developed in an effort to purify the agglutinin. Products from the chromatographic procedure were found not to contain higher specific agglutinating activities than the crude extract. Amino acid acid analyses of the extract showed the presence of relatively high proportions of glutamic and aspartic acids. In addition, the extract contained phosphorus and a visible chromophore. The agglutinin was resistant to detergents and denaturants, and proteases, nucleases, and other enzymes. The results suggest that, as opposed to other plant agglutinins, the active component from Persea is not a protein. Similarly, in contrast to many lectins, the agglutinin from Persea was not mitogenic for mouse lymphocytes. The agglutinin partially inhibited the mitogenesis of lymphocytes when the cells were treated with concanavalin A, or with bacterial lipopolysaccharide.