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Principles and Methods of Ocular Pharmacokinetic Evaluation
Published in David W. Hobson, Dermal and Ocular Toxicology, 2020
Another analytical method is bioassay. This approach is useful for testing antibiotics. Tissue samples can be extracted and the material placed on agar plates of colonies of bacteria.109,110 Concentrations are obtained from the distribution of the colonies and the areas in which bacteria are prevented from growing.
Analytical Method and Assay
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
Spanning the complete drug development process, from early discovery to clinical trial and manufacturing, measurements are legion. Analytical methods and assays are these central pieces that allow obtaining the analytical results on which all the decisions are taken: a batch release, the drug efficacy, some toxicology issues, the drug stability and the drug shelf-life, …the list is endless. Without these results, nobody would be able to characterize the drug product and its intermediates during manufacturing.
Physico-Chemical Methods for the Quality Control of Medicinal Plants, Plant Derivatives and Phytomedicines in Brazil
Published in Luzia Valentina Modolo, Mary Ann Foglio, Brazilian Medicinal Plants, 2019
Paula Carolina Pires Bueno, Alberto José Cavalheiro
Apart from being necessary for the reliability of the results in the context of the quality system, the validation of analytical methods is justified for legal, technical and commercial reasons. The international bodies and agencies, such as IUPAC (International Union of Pure and Applied Chemistry), FDA (Food and Drug Administration) and ICH (International Conference on Harmonization), and the Brazilian organizations such as INMETRO (National Institute of Metrology, Quality and Technology) and ANVISA, provide guidelines and recommendations for the execution of validation procedures, a fundamental requirement for demonstration of process technical competence.
Development and validation of HPLC method for simultaneous determination of Leflunomide and folic acid in the nanoparticulate system by reversed-phase HPLC
Published in Drug Development and Industrial Pharmacy, 2023
Bazla Siddiqui, Haroon Ahmed, Ihsan-ul- Haq, Asim.ur. Rehman, Naveed Ahmed
Reliability of the developed analytical method can be indicated by robustness after the introduction of deliberate variations in the analytical method. These parameters can affect the performance of the developed method, such as accuracy. The composition of the mobile phase, pH of the mobile phase, its flow rate, injection volume and column temperature were slightly altered from actual values to find their effect on the retention time. The flow rate was set between 0.8 and 1.2 ml/min, the pH of the mobile phase was changed upto ± 0.2 by changing the concentration of phosphoric acid, column temperature was varied to ± 2 °C and the injection volume was changed from 40 to 60 µL. The change in retention time was observed and relative standard deviation (% RSD) was calculated for observed factors. Ruggedness of the method was performed by two different analysts on separate samples of LEF/FA. Both analysts prepared the samples and analyzed them on separate instruments in a triplicate. The % RSD values of all observations should not be greater than 2% in accordance with the ICH guidelines, Q2B (R1) (1996) for method validation [29].
Occupational risk assessment of exposure to metals in chrome plating workers
Published in Drug and Chemical Toxicology, 2022
Cristina Deuner Muller, Solange Cristina Garcia, Natália Brucker, Gabriela Goethel, Elisa Sauer, Larissa Machado Lacerda, Evandro Oliveira, Thereza Luciano Trombini, Aline Belem Machado, Anelise Pressotto, Virginia Cielo Rech, Cláudia Regina Klauck, Luciano Basso da Silva, Adriana Gioda, Luciane Rosa Feksa
For the measurement of non-essential metals in the biological samples, 1 mL 65% ultrapure nitric acid was added to 500 μL of the sample in a polypropylene digestion tube as described by Lacerda et al. (2019). Afterward, whole blood concentrations of chromium (Cr), vanadium (V), nickel (Ni), lead (Pb) and, the semimetal, arsenic (As) were analyzed by inductively coupled plasma-mass spectrometry (ICP-MS; PerkinElmer-Sciex, Waltham, MA) (Mateus et al. 2013). Calibration solutions were prepared using a 10 mg/L stock solution (PerkinElmer 29, Waltham, MA). Precision and accuracy of the analytical method were monitored with reference standards that were analyzed in intervals of 15 samples. The measurement of Cr in urine was performed by the same methodology, ICP-MS. Creatinine concentration in urine was measured by spectrophotometry, using commercial laboratory kit (Doles reagents, Goiânia, Brazil).
Solubilization of a novel antitumor drug ribociclib in water and ten different organic solvents at different temperatures
Published in Drug Development and Industrial Pharmacy, 2022
Ramadan Al-Shdefat, Mohammad Hailat, Osama Y. Alshogran
RCB solvated in several solvents was evaluated according to the reported method with slight modifications [13]. The analysis was performed using Dionex UltiMate 3000 RS UHPLC system (Thermo Fisher Scientific, Darmstadt, Germany). The C18 column Agela Unisole 150 × 4.6 mm, 5 µm was used for the separation. The mobile phase consisted of 10 mM potassium dihydrogen phosphate pH 3.8, acetonitrile, and methanol (65:15:20, v/v/v). The mobile phase was filtered and degassed through a 0.45 µm membrane, delivered at ambient temperature at a 1 ml min−1 flow rate. The detector was set at λmax = 271 nm, and the injection volume was 30 µL. The proposed analytical method was validated in terms of quantification range, accuracy, precision, specificity, and robustness.