Clinical Pharmacy Articles

Jill Weschler
Applied Clinical Trials, Dec 1, 2003

Pharma's finger of blame o­nce again points outward, never inward.Lack of clinical trials infrastructure "may become an important bottleneck" for provision of medicines in poorer countries, warns a new pharmaceutical industry attempt to justify and defend the lack of effective action to date o­n medicines provision for diseases in the developing world. A just-published study from the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) called "Research and Development for Neglected Diseases: Lessons Learned and Remaining Challenges" [available at http://www.efpia.org/2_indust/IFPMAbrochnegdis2004.pdf] aims to deflect some of the criticism the drug industry has been attracting as the north-south gap in medicines provision widens.

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The EU has nailed down its strategy for strengthening its clinical trials industry, but it still isn’t clear how it will meet those goals.

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Leaders in the European regulatory community examine the implications and merits of the EU’s new clinical trials regulations—and find themselves buried in minor details.

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Syphilis is a chronic disease with a waxing and waning course, the manifestations of which have been described for centuries. It occurs worldwide, and the incidence varies significantly with geographic location. Transmission is mainly by sexual contact. The causative organism, Treponema pallidum, was first described in 1905, but because of the inability to culture the organism and the limitations of direct microscopy, serologic testing is the mainstay of laboratory diagnosis. The disease has been arbitrarily divided into several stages. The primary stage is defined by a chancre at the site of inoculation. The secondary stage is characterized by a polymorphic rash, lymphadenopathy, and other systemic manifestations. A variable asymptomatic latent period follows, which for epidemiologic purposes is divided into early (<1 year) and late (>1 year) stages. The early stages (primary, secondary, and early latent) are potentially infectious.

Lise Eliot, Allen Cato III, Rita Geiser, Gordon Loewen
the Journal of Applied Research

This paper deals with an observational retrospective study of the paediatric use of filgrastim. A total of 64 episodes were studied. The indication in most cases was secondary prophylaxis of chemotherapy-induced neutropenia (33 episodes). The indication for established febrile neutropenia was evaluated in 30 episodes and 1 episode corresponded to severe congenital neutropenia. The indications for filgrastim in the group of patients studied conform to the indications authorized for that medication in Spain and to the ASCO’s guidelines. The average dosage for prophylaxis and treatment of febrile neutropenia was 7 mg/kg/day, i.e. higher than the recommended adult dosage. Febrile neutropenia appeared in 58.8% of the episodes of prophylaxis, which suggests that children may need higher dosages. The dosage of 8 mg/kg/day for treatment of severe congenital neutropenia was effective. KEY WORDS: Filgrastim, paediatric, therapeutic use

As so many articles have noted,1 the uptake of electronic data capture (EDC) and associated technologies has continued to be disappointing. Even though 20 years ago experts predicted that electronic case report forms (CRFs) would replace paper as a natural consequence of the introduction of computers, this has not been the case.

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R. P. D. Cooke, MRCP(UK), FRCPath, D. Binyon, MRPharmS, MSc, and S. V. Goddard, RGN
Hospital Pharmacist Vol 7 No 2 p52-54
February 2000

European Research Commissioner Philippe Busquin tours Africa to bring attention to the plight of developing nations unable to afford modern medicines.

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