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In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study.
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- AAPS Journal, 2015, v. 17, n. 3, p. 684, doi. 10.1208/s12248-015-9741-9
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- Article
Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes.
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- AAPS Journal, 2013, v. 15, n. 1, p. 70, doi. 10.1208/s12248-012-9414-x
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- Article
Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision.
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- AAPS Journal, 2011, v. 13, n. 2, p. 291, doi. 10.1208/s12248-011-9271-z
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- Article