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38: 9128 Acknowledgements The authors would like to thank Ms Wave Sewlall, Ms Lauren Graham and Ms Judy Inge for their expert assistance in the preparation of this manuscript
10.1038/bjc.2013.269 Br J Cancer
The purity figure printed on each batch's Certificate of Analysis is the actual value recorded in the laboratory for that batch, not a generic marketing claim
The evolving framework under ICH S1B(R1) further emphasizes a modern, evidence-integrated approach to long-term safety evaluation
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