Drug Shelf Life and Release Limits Estimation Based on Manufacturing Process Capability von Oliva, Alexis, Llabrés, Matías

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Limitations of the quality range approach in analytical similarity assessment: Effect of mean shift and relative variability von Oliva, Alexis, Llabrés, Matías

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New Quality-Range-Setting Method Based on Between- and Within-Batch Variability for Biosimilarity Assessment von Oliva, Alexis, Llabrés, Matías

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Uncertainty of Size-Exclusion Chromatography Method in Quality Control of Bevacizumab Batches von Oliva, Alexis, Llabrés, Matías

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Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study von Oliva, Alexis, Llabrés, Matías

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Fitting bevacizumab aggregation kinetic data with the Finke–Watzky two-step model: Effect of thermal and mechanical stress von Oliva, Alexis, Llabrés, Matías, Fariña, José B.

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Pre-study and in-study validation of a size-exclusion chromatography method with different detection modes for the analysis of monoclonal antibody aggregates von Oliva, Alexis, Fariña, Jose B., Llabrés, Matías

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Capability measurement of size-exclusion chromatography with a light-scattering detection method in a stability study of bevacizumab using the process capability indices von Oliva, Alexis, Llabrés, Matías, Fariña, José B.

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Development and validation of an UPLC method for determination of content uniformity in low-dose solid drugs products using the design space approach von Oliva, Alexis, Fariña, José B., Llabrés, Matías

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An improved methodology for data analysis in accelerated stability studies of peptide drugs: Practical considerations von Oliva, Alexis, Fariña, José B., Llabrés, Matías

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Data analysis in stability studies of biopharmaceutical drugs with isothermal and non-isothermal assays von Oliva, Alexis, Llabrés, Matías, Fariña, José B.

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Pharmacokinetics analysis of sustained release hGH biodegradable implantable tablets using a mouse model of human ovarian cancer von Santoveña, Ana, Fariña, José B., Llabrés, Matías, Zhu, Yonglian, Dannies, Priscilla

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Application of a validated stability-indicating chromatographic method to evaluate the reproducibility between batches of small peptides in solution von Oliva, Alexis, Llabrés, Matías, Fariña, José B.

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Estimation of uncertainty in size-exclusion chromatography with a double detection system (light-scattering and refractive index) von Oliva, Alexis, Llabrés, Matías, Fariña, José B.

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Application of capability indices and control charts in the analytical method control strategy von Oliva, Alexis, Llabres Martinez, Matías

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Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in... von Oliva, Alexis, Monzón, Cecilia, Santoveña, Ana, Fariña, José B., Llabrés, Matías

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Evaluation of non-isothermal methods in stability studies of human insulin pharmaceutical preparations von Oliva, Alexis, Suárez, Marta, Hernández, Juan Ramón, Llabrés, Matías, Fariña, José B.

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Solid-state stability studies of cholecystokinin (CCK-4) peptide under nonisothermal conditions using thermal analysis, chromatography and mass spectrometry von Oliva, Alexis, Ashen, David Sánchez, Salmona, Mario, Fariña, José B., Llabrés, Matías

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Data analysis of kinetic modelling used in drug stability studies : Isothermal Versus nonisothermal assays von OLIVA, Alexis, LLABRES, Matias, FARINA, José B

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New approach to stability assessment of protein solution formulations by differential scanning calorimetry von Cueto, Madaisy, Dorta, M.Jesús, Munguı&#x0301, a, Obdulia, Llabrés, Matı&#x0301, as

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