Survey of Safety Information in the Investigator's Brochure: Inconsistencies and Recommendations.

A survey was undertaken to gain an understanding of current industry practices in the preparation of the safety information for the Investigator's Brochure (IB). Sixteen of a potential 25 respondents completed a survey (64% response rate). Five respondents represented pharmaceutical and biotech companies, and 11 were consultants or worked at contract research organizations for such companies.

APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy.

Aim: APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV). We compared efficacy and safety of APF530 versus ondansetron for delayed CINV after highly emetogenic chemotherapy (HEC), following a guideline-recommended three-drug regimen.

Methods: HEC patients received APF530 500 mg subcutaneously or ondansetron 0.

Individual case safety reports--how to determine the onset date of an adverse reaction: a survey.

Background: The building blocks of a pharmacovigilance system depend primarily on good quality individual case safety reports (ICSRs), which are stand-alone summaries describing one or more suspected adverse reactions that occur while a subject is taking either an investigational or marketed medicinal product and may require expedited reporting to regulatory authorities. For regulatory reporting purposes, the information of an ICSR is usually captured on forms such as MedWatch 3500/3500A, CIOMS I, Vaccine Adverse Event Report System (VAERS) or Adverse Events Following Immunization (AEFI). ICSRs that are sent electronically must meet the standards for electronic transmission specified in the International Conference on Harmonisation (ICH) E2B (R2) guideline.

The periodic safety update report as a pharmacovigilance tool.

The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool.

Subclinical Hypothyroidism and Euthyroid Sick Syndrome in Patients with Moderate-to-Severe Congestive Heart Failure.

Thyroid function tests were performed on baseline plasma that had been taken from 34 patients with NYHA Class II or Class III congestive heart failure (CHF). All patients were negative for thyroid disease on history and physical examination and none was taking medication known to alter thyroid metabolism. Analysis of thyroid function revealed abnormalities in 16 of 31 patients.