Helmut Rockstroh

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Helmut Rockstroh is head, pharmacopoeial affairs office, F. Hoffmann-La Roche Ltd.

Articles

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Sarah Thompson;Nancy Lewen;Graham Cook;Andrew Teasdale;Katherine Ulman;Lance Smallshaw;Carlos W. Lee;Helmut Rockstroh;John Glennon;Samuel Powell;Cyrille C. Chéry;Laura Rutter;Laurence Harris;Vicki Woodward

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

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