Assessing goodness-of-fit for evaluation of dose-proportionality

For the clinical development of a new drug, the determination of dose-proportionality is an essential part of the pharmacokinetic evaluations, which may provide early indications of non-linear pharmacokinetics and may help to identify sub-populations with divergent clearances. Prior to making any conclusions regarding dose-proportionality, the goodness-of-fit of the model must be assessed to evaluate the model performance. We propose the use of simulation-based visual predictive checks to improve the validity of dose-proportionality conclusions for complex designs. We provide an illustrative example and include a table to facilitate review by regulatory authorities.     

Exactness and precision

Policy Delphi methods have not received the level of methodological scrutiny evidenced by more established techniques. This paper provides an examination of the potential for study participants to opt in/opt out of consecutive Delphi rounds. The literature proposes that this is a positive feature of the approach but evidence to support this position is lacking. This paper provides a brief review of the Policy Delphi method and than presents details of participation patterns in a study where the opt‐in/opt‐out option was available. Findings showed that participants exercised the option of opting in/opting out of different Delphi rounds. Although only 20.6% of the original participants completed all three Delphi rounds, the response rate (regardless of participants’ involvement in previous rounds) across all three Delphi rounds held fairly consistent at around 40%. These findings are significant as they relate to the need for an expanded repertoire of research tools that can address the complex, non‐linear questions emerging in post‐modern society.     

Interaktion des <Emphasis Type="Italic">als ob</Emphasis>: Privatanleger und Anlageberater

Since the late nineties, stock market investments have become an attractive option for many who want to secure or improve their standard of living, although ?stocks“ are an obscure subject for most of them. They have to rely on investment consultants in banks. Until the stock market crash, there was no reason to complain about the consulting process — shares kept going up in value.But it is remarkable that following the crash, which caused many investors to lose a large amount of money, the relationship between private investors and investment consultants does not seem to have been damaged.In our paper we first show the legal requirements for investment consulting and how these requirements are implemented by banks, and we identify considerable discrepancies between the theoretical and the actual fulfillment of these legal requirements.We then show that it is impossible to meet these requirements in reality because they rely on unrealistic assumptions regarding a consulting process that both adequately covers investment options and addresses the needs of investors. We argue that both sides are more or less satisfied with the situation because they operate on an as if basis: consultant and client talk and behave as if they understood each other.As if the consultant had really informed the client and as if the client had really understood the consultant. This as if which both parties are aware of but which is not openly discussed is the condition of a successful consultancy process and for making the business happen.