Publications by the researcher in collaboration with Alexis Manuel Oliva Martín (37)

2023

  1. Drug Shelf Life and Release Limits Estimation Based on Manufacturing Process Capability

    Pharmaceutics, Vol. 15, Núm. 4

2021

  1. Limitations of the quality range approach in analytical similarity assessment: Effect of mean shift and relative variability

    Journal of Pharmaceutical and Biomedical Analysis, Vol. 198

  2. New quality-range-setting method based on between- and within-batch variability for biosimilarity assessment

    Pharmaceuticals, Vol. 14, Núm. 6

  3. Uncertainty of size-exclusion chromatography method in quality control of bevacizumab batches

    Separations, Vol. 8, Núm. 9

2019

  1. Validation of a size-exclusion chromatography method for bevacizumab quantitation in pharmaceutical preparations: Application in a biosimilar study

    Separations, Vol. 6, Núm. 3

2017

  1. Application of capability indices and control charts in the analytical method control strategy

    Journal of Separation Science, Vol. 40, Núm. 15, pp. 3046-3053

2016

  1. Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index

    Journal of Separation Science, Vol. 39, Núm. 14, pp. 2689-2701

  2. Pre-study and in-study validation of a size-exclusion chromatography method with different detection modes for the analysis of monoclonal antibody aggregates

    Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Vol. 1022, pp. 206-212

2015

  1. Fitting bevacizumab aggregation kinetic data with the Finke-Watzky two-step model: Effect of thermal and mechanical stress

    European Journal of Pharmaceutical Sciences, Vol. 77, pp. 170-179

2014

  1. Capability measurement of size-exclusion chromatography with a light-scattering detection method in a stability study of bevacizumab using the process capability indices

    Journal of Chromatography A, Vol. 1353, pp. 89-98

2013

  1. Development and validation of an UPLC method for determination of content uniformity in low-dose solid drugs products using the design space approach

    Talanta, Vol. 115, pp. 490-499

2012

  1. An improved methodology for data analysis in accelerated stability studies of peptide drugs: Practical considerations

    Talanta, Vol. 94, pp. 158-166

2011

  1. Data analysis in stability studies of biopharmaceutical drugs with isothermal and non-isothermal assays

    TrAC - Trends in Analytical Chemistry, Vol. 30, Núm. 5, pp. 717-730

2010

  1. Anti-tumor effects of adenovirus containing human growth hormone sequences in a mouse model of human ovarian cancer

    Endocrine, Vol. 37, Núm. 3, pp. 430-439

  2. Application of a validated stability-indicating chromatographic method to evaluate the reproducibility between batches of small peptides in solution

    Analytica Chimica Acta, Vol. 675, Núm. 1, pp. 83-90

  3. Solid-state stability studies of cholecystokinin (CCK-4) peptide under nonisothermal conditions using thermal analysis, chromatography and mass spectrometry

    European Journal of Pharmaceutical Sciences, Vol. 39, Núm. 4, pp. 263-271

2009

  1. Estimation of uncertainty in size-exclusion chromatography with a double detection system (light-scattering and refractive index)

    Talanta, Vol. 78, Núm. 3, pp. 781-789

  2. Evaluation of non-isothermal methods in stability studies of human insulin pharmaceutical preparations

    Journal of Pharmaceutical and Biomedical Analysis, Vol. 49, Núm. 4, pp. 916-922

2007

  1. Application of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and hydrogen exchange combined with enzymatic digestion for the structural characterization of antimalaric Spf66 peptide

    Talanta, Vol. 72, Núm. 3, pp. 1192-1198

  2. New trends in analysis of biopharmaceutical products

    Current Pharmaceutical Analysis, Vol. 3, Núm. 4, pp. 230-248