The discovery of cisplatin more than two decades ago was the most important therapeutic advance in the treatment of ovarian cancer. Today, cisplatin or carboplatin in combination with paclitaxel is the most commonly used first-line treatment for patients with advanced ovarian cancer. Although platinum drugs remain a critical component of chemotherapy in this type of cancer, cumulative toxicitie...

Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates m...

BACKGROUND Stroke is one of the major challenges to health and the reason for increasing disability-adjusted life years. Despite tremendous progress in preclinical studies, none of the treatment options has proven efficacious in clinical studies. The basic aim of neuroprotection is to interfere with the events of the ischemic cascade, halt the pathological processes and prevent the death of vul...

We collected data during postexposure antimicrobial prophylaxis campaigns and from a prophylaxis program evaluation 60 days after start of antimicrobial prophylaxis involving persons from six U.S. sites where Bacillus anthracis exposures occurred. Adverse events associated with antimicrobial prophylaxis to prevent anthrax were commonly reported, but hospitalizations and serious adverse events a...

IND Pub * Ithac WA. cally. Mont Oppo and comm Using data from 84 hospitals linked to Equal Employment Opportunity Commission discrimination-charge data, we consider how four human resource (HR) structures affect hospitals’ receipt of discrimination charges. HR structures that establish accountability (affirmative action plans, EEO units) are marginally related to charges. Structures that modera...

The aim of this paper is to identify some of the generic problems that restrict effective product development within SME medical manufacturers. The content of the paper is based on the preliminary findings of a European funded project that looks at key issues restricting growth in this industry sector. The paper reports the outcomes of a series of in-depth interviews with senior SME managers wi...

Article Type: Review There are many difficulties and deficiencies in chemotherapeutic drugs especially drug resistances that appear in cancer chemotherapy. In spite of the fact that chemotherapeutic drugs are very effective, severe side effects limit the use of these drugs. People have to pay more attention to natural sources of cancer drugs to increase the anti-cancer agents present in the dru...

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in tu...

The Food and Drug Administration (FDA) Critical Path Initiative as well as the European Medicines Agency Road Map to 2010 (ref. 2) call for opportunities for more efficient drug development. One of the initiatives that has emerged in this context is the elaboration through guidance of exploratory investigational new drugs (INDs)/clinical trial applications (CTAs). This article reviews the histo...