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Master Thesis

Standardisation des doses (ou "Dose-Banding") des médicaments injectables : application à deux principes actifs l'aciclovir et l'infliximab

Abstract : Due to the increasing demands of injectable cytotoxic treatments in our institution without additional human resources, we investigated in the present study the possible implementation of dose standard or dose banding to improve the workload. International practices of "dose-banding" were firstly reviewed and we created a multidisciplinary working group of physicians and pharmacists to select the eligible drugs for standardization. The selection criteria were the high annual quantities of produced doses (> 1500 / year) and the physicochemical stability at least above 14 days for cytotoxics and above 7 days for monoclonal antibodies. Among the 14 drugs selected, we decided to firstly focus on the drugs used in gastro enterology pathologies. Selected drugs were 4 cytotoxics oxaliplatin, camptothecin, 5-fluorouracil, and gemcitabine and one monoclonal antibody infliximab. Moreover one antiviral drug, aciclovir, which was the most prepared drug was selected as well. Dose deviations of +/- 10% was agreed with prescribers for the monoclonal antibody and +/- 5% for cytotoxic and +/- 15% for aciclovir. Five average doses per drug covering more than 80% of the production were determined. For early production of standard doses, two scenarii were selected depending on the cost of the drug. - Batch production for low cost drugs and long physico-chemical stabilities such as aciclovir - Repeated series of the same dose for high cost drugs with short stability such as infliximab In our work, we used aciclovir as model drug for batch process validation. According to good manufacturing practices it was mandatory to select and qualify the peristaltic pump, to validate the process with regards to media fill tests and sterility testing. Due to quite short expiry dates (around one month) we excluded the Pharmacopeia usual method and we had to validate rapid microbiology methods.
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Master Thesis
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Submitted on : Tuesday, May 3, 2016 - 12:06:14 PM
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  • HAL Id : dumas-01310879, version 1



Lucie Sauvaget. Standardisation des doses (ou "Dose-Banding") des médicaments injectables : application à deux principes actifs l'aciclovir et l'infliximab. Sciences pharmaceutiques. 2016. ⟨dumas-01310879⟩



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