Using nanotechnology to improve the characteristics of antineoplastic drugs: improved characteristics of nab-paclitaxel compared with solvent-based paclitaxel.

Nanotechnology refers to the use of very small pieces of matter, typically < or =200 nm in diameter. Nanoparticle albumin-bound (nab) paclitaxel, a soluble form of the cytotoxin paclitaxel that has demonstrated utility in the setting of cancer chemotherapy, is produced by nab technology using the protein albumin. nab-Paclitaxel targets tumors, enhances tumor penetration by the novel mechanism of albumin receptor-mediated (gp60) endothelial transcytosis, and avoids the use of surfactants and solvents such as Cremophor and Tween.

Medical writing departments in biopharma companies: how to establish a department.

Medical writers have important roles in preparing the documentation for approval for marketing of new products, writing manuscripts for publication, and other nonclinical, clinical, and promotional materials. Medical writing departments can be organized in different ways to accommodate the needs of the company. When organizing a new department or when determining metric for an existing department, it is important to understand what medical writers in the biopharma industry do, how they are recruited and trained, and how metrics are developed.

Clinical trial registries and clinical trial result posting: new paradigm for medical writers.

Clinical trial registries and posting of clinical trial results have recently become standard procedures for drug development. Several groups, including journal editors and professional trade organizations have called for legislation or have mandated terms or both for the public disclosure of current trials and the results of the clinical trials within a short timeframe after the trial has ended.

A prospective, non-randomised phase 1-2 trial of VACOP-B with filgrastim support for HIV-related non-Hodgkin's lymphoma.

Non-Hodgkin's lymphoma (NHL) remains an important complication of associated HIV infection despite advances in antiretroviral therapy (ART), and the optimum chemotherapy regimen for this disease remains to be defined. A dose-escalation trial was performed to determine the maximum tolerated doses of etoposide and doxorubicin as part of the 12-week VACOP-B regimen, supported by filgrastim (r-metHuG-CSF). Patients with aggressive histology HIV-related NHL who were previously untreated with chemotherapy, and who had no active opportunistic infection were eligible for the study.

Guidelines and policies for medical writers in the biotech industry: an update on the controversy.

Papers reporting the results of clinical trials written by medical writers employed by the biotech and pharmaceutical industries have been criticized for possible bias in presentation and failure to adhere to authorship guidelines. Several groups have attempted to address the concerns of journal editors, academics, regulators, and the general public by issuing guidelines and policies for the preparation of such material.

Using the biologic license application or new drug application as a basis for the common technical document.

With the introduction of the common technical document (CTD), many writers in the biotech and pharmaceutical industries are now required to submit dossiers in this format. The format of the CTD is not extremely difficult from the familiar documents of the Biologic License Application (BLA) or New Drug Application (NDA). The CTD can be mapped to existing areas of the BLA or NDA.

Drug-induced and antibody-mediated pure red cell aplasia: a review of literature and current knowledge.

Anti-erythropoietin (EPO)-induced pure red cell aplasia (PRCA) is an uncommon, potentially life-threatening condition in which the bone marrow stops manufacturing red blood cells. In the past few years, reports of drug-induced, anti-EPO antibody-mediated PRCA have increased substantially, with most cases attributed to the use of one erythropoiesis-stimulating protein, Eprex. A literature review was undertaken to document the reports of drug-induced PRCA, with all drugs and drug regimens.

The development of supportive-care agents for patients with cancer.

As the population ages, a dramatic increase in the number of cases of cancer is expected and the need for supportive-care agents, those used to ameliorate some of the side effects of cancer or its treatment, becomes more urgent. At present, supportive-care products are available and new agents are being developed with novel mechanisms of action or modifications of existing agents that improve performance. Because of the urgent need for such products, efficient development is required to deliver useful products to patients as rapidly as possible.

Review of current authorship guidelines and the controversy regarding publication of clinical trial data.

Publication of clinical trial data is the final step in the scientific method and an important method by which pharmaceutical and biotechnology companies, i.e., drug sponsors, disseminate information about their products.

Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.

Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions.

Darbepoetin alfa: a new approach to the treatment of chemotherapy-induced anaemia.

Chemotherapy-induced anaemia has important consequences on the quality of life and social function of cancer patients. The finding of erythropoietin (EPO) deficiency in these patients led to the therapeutic development of erythropoietic proteins. Darbepoetin alfa (Aranesp), Amgen Inc, Thousand Oaks, California), a new erythropoietic growth factor, has eight more sialic acids than epoetin alfa.

Pharmacologic and cytokine treatment of commonly encountered anemias.

Anemia has multiple etiologies: it may be caused by nutritional deficiencies or congenital abnormalities, or it may be associated with a number of conditions, such as chronic kidney disease, cancer, or human immunodeficiency virus (HIV) infection. Anemia is associated with an increase in morbidity and mortality in patients with endstage renal disease, cancer, or HIV infection. Each case of anemia is different, with different causes, clinical consequences, and treatment strategies.