Search results for "Pharmaceutical Industry"

European Databases on Stability and Compatibility of Injectable Medicinal Products in Europe

2020

AbstractIn hospitals, the majority of medication therapy is administered intravenously. Especially, in intensive care units, simultaneous of various injectable drugs is a common practice Drug incompatibilities have been reported to be associated with up to 60 % of all serious and life-threatening adverse drug events. Several databases are used by hospital pharmacists to answer the questions of (in)compatibility of co-administered injectable drugs. The objective of this article is to present the European databases on compatibility and stability of injectable drugs. According to a questionnaire which was sent to the National Hospital Pharmacy Associations of the 28 countries of European Commu…

Environmental and Product Contamination during the Preparation of Antineoplastic Drugs with Robotic Systems

2018

Abstract Background Robotic systems are designed to minimize the exposure to antineoplastic drugs during automated preparation. However, contamination cannot be completely excluded. The aim of the study was to evaluate the contamination with antineoplastic drugs on the working surfaces and on the outer surface of the ready-to-use products (infusion bags and syringes) during automated preparation with different versions of a robot and manual preparation. Methods Surface contamination with platinum (Pt) and 5-fluorouracil (5-FU) was measured by wipe sampling and quantified by voltammetry for Pt and GC-MS for 5-FU. Sampling was performed on pre-defined locations in the working areas before and…

Pharmacogenomics: questions and concerns

2005

The progressively aging population in the western world, rising socioeconomic expenditure and increasing costs for the treatment of adverse drug reactions, lead to increasing pressure on public spending. The public acceptance of pharmacogenomics is high, therefore, because it promises individualized safe and effective treatment at lower cost. Pharmacogenomics studies the genetic polymorphisms that underlie the variability in drug response between individuals. Despite the great benefits being awaited from this new field, a number of ethical, social and legal concerns arise, which demand rapid strict international regulations in order to prevent discrimination or harm of any kind from society…

Darwinism and pharmacogenomics: from 'one treatment fits all' to 'selection of the richest'?

2004

Pharmacogenomics and pharmacogenetics are relatively new fields, and have arisen from recent advances in genetic research. They offer new perspectives on the development of pharmaceuticals, allowing drug design to be targeted specifically to the genotype of selected populations. The discussion of who will be considered for the development of these tailored drugs and who will be excluded, in a situation in which both research resources and public expenditure are limited, is provoking and has led to several, still unanswered ethical questions and concerns about fairness and the potential discrimination of fringe groups. Based on the statistical analyses of population averages, patient groups …

Open innovation: A real option to restore value to the biopharmaceutical R&D

2014

The pharmaceutical landscape has changed, and new business models, based on alliances, are increasingly being adopted in this industry. Biotechnology advances have pushed this development, and pooling complementary resources coming from incumbents and newcomers is a key skill to succeed: these are the premises for a quick spread of the open innovation (OI) paradigm in this industry. R&D portfolio selection needs R&D project evaluation, and Real Options Analysis (ROA) is acknowledged as a powerful tool to evaluate uncertain projects that have an intrinsic flexibility. The present research aims to foster the use of ROA in the OI field in order to encourage firms to undertake this innovation mode…

A real options based model to select a balanced R&D portfolio

2011

The R&D process in the pharmaceutical industry has a long and dynamic life then it is an ideal field of application for ROA. Actually, ROA implementation, as widely demonstrated in literature, is narrowed to very limited cases because its perceived complexity. This research wants to suggest a simplified method, respect the ones available in literature, that could foster the use of ROA: we built up an integer linear programming model, based on a model available in literature, useful for selecting a balanced R&D portfolio from a set of candidate drugs. The model has been tested through a case study.

An affordable way to implement real options to select optimal R&D portfolio

2011

Real option Analysis (ROA) is acknowledged as a powerful tool to evaluate uncertain projects whose uncertainty depends heavily on alternatives available along the project life. The R&D process in the pharmaceutical industry has a long and dynamic life then it is an ideal field of application for ROA. Actually, ROA implementation, as widely demonstrated in literature, is narrowed to very limited cases because its perceived complexity. This research wants to suggest a simplified method, respect the ones available in literature, that could foster the use of ROA: we built up an integer linear programming model, based on a model available in literature, useful for selecting the optimal R&D produ…

A real options based support system to open innovation

2012

Pharmaceutical R&D process (PR&DP) has been deeply investigated by different streams of literature; the interest is due to the strategic implication of the related decisions undertaken. The PR&DP has been revolutionised by the biotech advent and as a consequence R&D managers cannot avoid to consider Open Innovation paradigm during this decision process. Starting from a Real Option optimization model available in literature, the paper aims at proposing a decision support system (DSS) able to suggest the candidate products to be included in the best R&D portfolio varying input parameters (resilient products), to provide a products Pareto analysis that aims at individuating the products for wh…

Capital Structure Decisions in the Biopharmaceutical Industry

2011

A new decision model for economic evaluation of novel therapies for HCV

2014

In 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is inten…