Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
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Direct detection of a sulfonate ester genotoxic impurity by atmospheric-pressure thermal desorption-extractive electrospray-mass spectrometry.A systematic assessment of genotoxicity on pivaloylacylation-7ADCA-a wide existing antibiotic impurityConsequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients.The cancer threshold of toxicological concern (TTC) in relation to foodstuffs and pharmaceuticals: A potentially useful concept compromised by a dubious derivation.Experimental design for the optimization and robustness testing of a liquid chromatography tandem mass spectrometry method for the trace analysis of the potentially genotoxic 1,3-diisopropylurea.
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Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
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article científic
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article scientifique
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articolo scientifico
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artigo científico
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bilimsel makale
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scientific article published on 21 March 2011
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vedecký článok
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vetenskaplig artikel
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videnskabelig artikel
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vědecký článek
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Overall impact of the regulato ...... the drug development process.
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Overall impact of the regulato ...... the drug development process.
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Overall impact of the regulato ...... the drug development process.
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Overall impact of the regulato ...... the drug development process.
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Overall impact of the regulato ...... the drug development process.
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Overall impact of the regulato ...... the drug development process.
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P2093
P1476
Overall impact of the regulato ...... the drug development process.
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P2093
Antonio Giordani
Hans Ulrich Gally
Werner Kobel
P356
10.1016/J.EJPS.2011.03.004
P407
P577
2011-03-21T00:00:00Z