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Material Adverse Change

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Chapter 2 Thermal Expansion - Rice University

www.owlnet.rice.edu

CINDAS Data Series on Material Properties, Volumes 1 to 4, Thermal Expansion of Solids (Ref 1). Definitions Most solid materials expand upon heating and contract when cooled. The change in length with temperature for a solid material can be ex-pressed as: (l f – l 0)/l 0 = α 1 (T f – T 0) ∆l/l 0 = α 1∆T α 1 =1/l(dl/dT) where l 0 and l

  Change, Material

Q 5 E Comparability of Biotechnological/Biological Products

www.ema.europa.eu

• Although the pre- and post-change product appear highly similar, some differences have been observed in the quality attributes of the pre-change and post-change product, but it can be justified that no adverse impact on safety or efficacy profiles is expected, based on the manufacturer’s accumulated experience, relevant information, and data.

  Change, Adverse

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