To the obvious question of whether a specific conversion factor needs to be used for dose modifications, there is no clear-cut answer. Although the decrease in potency of the UHF finished product prepared with the new USP standard has averaged within a 7% to 13% range, various authorities (the FDA, the USP, and APP Pharmaceuticals) have stopped short of such a recommendation, citing the inherent low and variable bioavailability of heparin, lot-to-lot manufacturing variations, and the general sense that the change will not have clinical significance beyond current limits requiring monitoring of activated partial thromboplastin time (aPTT) or activated clotting time (ACT). The potential for heparin contamination, according to the FDA public health alert concerning the monograph change,1 is lessened because the production of a high-quality drug has been enhanced and new testing methods can detect impurities that the older method could not.
APP Pharmaceuticals, Inc. the largest supplier of heparin sodium to the U.S. market, has launched an educational Webinar series with industry experts about the USP monograph change.6 In the first installment, Edith A. Nutescu, PharmD, Clinical Professor of Pharmacy Practice at the University Of Illinois College of Pharmacy, stated that implementation of the stage 2 USP standards for UFH provides an opportunity to review relevant protocols and determine the need for modifications.
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The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa 34.4 with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs (e.g. the German DAB monograph). In addition, the Ph. Eur. is also working on monographs for Cannabis extracts.
The proposed limits for heavy metals are significantly lower compared to those provided in the general Ph. Eur. monograph Herbal Drugs (presumably due to the potential inhalation use). However, they are aligned with the limits proposed in the USP HMC monograph:
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Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25C); however, brief exposure up to 40C does not adversely affect the product.
(Bahia et al. 2014): Flatworm of free-living, long and narrow body; dorsal region cream with brown dots, more densely disposed at the median line; margin with orange dots (Fig. 2a); pharynx reaches 1/3 of the body length; seminal and prostatic vesicles highly muscularized; penis papilla and male atrium long.
(Amaral and Simone 2014): Shell shape cupped or oval; right valve slightly operculum-shaped; left valve, fixed in substrate, larger than right valve (Fig. 8e). Muscle impression is purple and adductor muscle, oval central in posterior region. Adductor muscle postero-dorsal located, occupying 1/5 of total size of animal; hood present and fully filled by palps and gonads; colour of mantle edge brown. Accessory heart of three branches of similar length, starting from common centre. Palps with margin superior free.
Background: The choice of mice strain can significantly influence the physiological distributionand may lead to an inadequate assessment of the radiopharmaceutical properties.Objective: This work aims to present how the legal requirements that apply to radiopharmaceuticalscontained in the various guidelines determine the choice of the mouse strain for quality controland preclinical studies and affect the results of physiological distribution.Methods: Swiss and BALB/c mice were chosen as commonly used strains in experiments for researchand quality control purposes. Radiopharmaceuticals, i.e., preparations containing one ormore radioactive isotopes in their composition, are subject to the same legal regulations at everystage of the research, development and routine quality control as all other medicines. Therefore, invivo experiments are to be carried out to confirm the pharmacological properties and safety. Moreover,if a radiopharmaceutical's chemical structure is unknown or complex and impossible to be determinedby physicochemical methods, an analysis of physiological distribution in a rodent animalmodel needs to be performed.Results: In our studies, thirty-six mice (Swiss n=18, BALB/c n=18) were randomly divided intosix groups and injected with the following radiopharmaceuticals: [99mTc]Tc-Colloid, [99mTc]Tc-DTPAand [99mTc]Tc-EHIDA. Measurement of physiological distribution was conducted following therequirements of European Pharmacopoeia (Ph. Eur.) monograph 0689, internal instructions and theUnited States Pharmacopeia (USP) monograph. Additionally, at preclinical studies, ten mice(Swiss n=5, BALB/c n=5) were injected with the new tracer [99mTc]Tc-PSMA-T4, and its physiologicaldistribution has been compared. The p-value
Abstract: Background: The choice of mice strain can significantly influence the physiological distributionand may lead to an inadequate assessment of the radiopharmaceutical properties.Objective: This work aims to present how the legal requirements that apply to radiopharmaceuticalscontained in the various guidelines determine the choice of the mouse strain for quality controland preclinical studies and affect the results of physiological distribution.Methods: Swiss and BALB/c mice were chosen as commonly used strains in experiments for researchand quality control purposes. Radiopharmaceuticals, i.e., preparations containing one ormore radioactive isotopes in their composition, are subject to the same legal regulations at everystage of the research, development and routine quality control as all other medicines. Therefore, invivo experiments are to be carried out to confirm the pharmacological properties and safety. Moreover,if a radiopharmaceutical's chemical structure is unknown or complex and impossible to be determinedby physicochemical methods, an analysis of physiological distribution in a rodent animalmodel needs to be performed.Results: In our studies, thirty-six mice (Swiss n=18, BALB/c n=18) were randomly divided intosix groups and injected with the following radiopharmaceuticals: [99mTc]Tc-Colloid, [99mTc]Tc-DTPAand [99mTc]Tc-EHIDA. Measurement of physiological distribution was conducted following therequirements of European Pharmacopoeia (Ph. Eur.) monograph 0689, internal instructions and theUnited States Pharmacopeia (USP) monograph. Additionally, at preclinical studies, ten mice(Swiss n=5, BALB/c n=5) were injected with the new tracer [99mTc]Tc-PSMA-T4, and its physiologicaldistribution has been compared. The p-value 2ff7e9595c
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