Pharmaceutical Programming 

Abstract: Posturography is used to assess the steadiness of the human body by measuring the movement of the centre of pressure of a standing subject on a force platform (stabilometry). This paper presents three different methods of calculating the centre of pressure trajectory. The first method ('Convex hull') is characterized by the area enclosed by the path of movement (body sway area), approximated by the area of a convex hull. PROC G3GRID is applied for the triangulation of the data points necessary for calculating the convex hull. This approach is compared with the second and most common procedure ('principal component analysis, PCA) which calculates an ellipse enclosing the sample points. PROC PRINCOMP is used to calculate the eigenvectors that represent the derived ellipse of the PCA. A third approach used in clinical studies ('Mean of Circle Areas') calculates the body sway area by summarizing the mean of the circle areas defined by the sample points and their distance to the point of origin. Simul...

Abstract: The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) is a standard for submitting data tabulations to the FDA in support of marketing applications. In July 2004, this standard became part of the FDA Study Data Specification referenced in the electronic Common Technical Document (eCTD) Guidance. This article will provide an overview of evolution and status of the SDTM and the associated Implementation Guides, commonly referred to as the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Standard for Exchange of Nonclinical Data (SEND).

Abstract: The disclosure of clinical trial 'basic' results on the website ClinicalTrials. gov has been legally required since September 2008 for all FDA-approved trials or cleared drugs and devices. Since that time, many additions (e.g.adverse event reporting in September 2009) and corrections (both content and format related) have been implemented. As most of the information needed for ClinicalTrials. gov is created anyway during the analysis and reporting of a clinical trial, a well-defined process can be established to collect the needed results during the programming of tables and listings for the trial report. In addition, the ongoing changes in the disclosure requirements and the different responsibilities and functions involved in trial disclosure lead to many challenges in defining and establishing such a process. This paper will focus on the process definition and execution from the programmer's perspective. We will also discuss common pain points of interpreting the ClinicalTrials. gov requirements.

Abstract: The post-marketing registries, established by the Italian Medicines Agency in 2005, represent the example of a national application of an automated workflow handling the personalized drug distribution in hospital pharmacies and local public pharmaceutical services, with the intent of both improving the efficacy/efficiency of analysis and regulatory activities themselves, as well as closely monitoring the clinical activity. In fact, within the correct clinical practice the prescriber shall take into account the parameters, such as therapeutic drug indication, actual benefit the patient should gain in comparison to the trials, potential and actual risk of adverse reactions, drugs interactions, and cost of the therapy. On the track of the cancer registry’s experience, the Italian Medicines Agency has extended the scope to the following areas: ophthalmology, rheumatology, dermatology, orphan drugs, cardiology, diabetology, respiratory, and neurological diseases. It involves more than 60 drugs (most of...