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ASTM International - ASTM F3142-16

Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

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Organization: ASTM International
Publication Date: 15 November 2016
Status: active
Page Count: 11
ICS Code (In vitro diagnostic test systems): 11.100.10
significance And Use:

4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and... View More

scope:

1.1 To describe general principles of developing and/or using an in vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs, with examples from the literature

1.2 The guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs.

1.3 In vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions, as well as characterization, and/or quality control.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Document History

ASTM F3142-16
November 15, 2016
Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and...
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