Assessing Compound Quality

Popa‐Burke, Ioana; Besley, Stephen; Blaxill, Zoe

doi:10.1002/9783527645251.ch3

Cited by 2 publications

(2 citation statements)

References 31 publications

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“…In Figure 3b , it is seen that more than 95% of the samples were negatively biased, meaning that the actual mass of the sample was consistently lower than the scale measurement showed. In recently published literature on the topic of compound quality in early drug discovery, 8 the same trend was noticed. In that experiment, when concentration measurements were performed on solutions that were supposed to be exactly 10 mM, the distribution of concentrations measured peaked at values lower (8–9 mM) than the 10 mM prepared.…”

Section: Resultssupporting

confidence: 56%

Analysis of Compound Weighing Precision in Drug Discovery

et al. 2013

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Early drug discovery laboratories often call for the precise weighing of 1- to 5-mg solids into 4- to 5-g glass vials. For the balance used in this study (Mettler Toledo XP205), the manufacturer rates its accuracy at ±0.01 mg over the working range of 1 mg to 220 g and its precision or repeatability at 0.015 mg for 10-g weights. The manufacturer ratings were confirmed using standard steel weights, but these calibrators do not well represent the weighing precision of drug compound. For example, when pre-taring a 4- to 5-g vial on the balance and then weighing 1- to 5-mg calibration weights, although no bias was observed, precision dropped appreciably. When measuring solid sample in the range of 1 to 5 mg, deviation of the measured weight from the actual (true) weight was even worse, in the range of ±20% to 50%. Balance settings and environmental factors exert a strong influence on weighing precision. Although most environmental factors, such as air draughts, temperature, vibrations, and levelness, can be optimized to the extent practical in laboratory settings, problems due to static electricity are often overlooked. By controlling static electricity, we demonstrate how we optimized the process to where measurements were within ±10% of actual weight when weighing solid sample in the range of 2 to 5 mg and ±20% when weighing 1 mg into a 4- to 5-g vial. Our weighing process and method to calculate actual weight are given in detail.

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Section: Resultssupporting

confidence: 56%

Analysis of Compound Weighing Precision in Drug Discovery

et al. 2013

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“…For both candidate and alliance material, the specialist must ensure that all appropriate approvals from project teams have been obtained and documented. Additional checks should be made to ensure that the material is available in inventory, meets quality standards 13 for provision externally, and is not regulated in the recipient’s country. 14 It is also necessary to review the proposed research checking for any potential animal or human biological sample (HBS) usage.…”

Section: Materials Transfer Agreementsmentioning

confidence: 99%

The Complexity of Compliance in Sample Management: A Review of Key Issues Impacting Small-Molecule and Biological Sample Management in Early Drug Discovery

Crimmin

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et al. 2019

SLAS Technology

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The discovery of new medicines has become increasingly more challenging and requires significant collaboration between pharma, biotech, academia, and technology to be successful. These partnerships necessitate the streamlined exchange of samples while adhering to the increasingly complex set of legal and proprietary restrictions, government legislation, and ethical considerations associated with samples. There is a significant volume of literature published on clinical sample compliance but little describing compliance aspects of discovery sample management. This paper describes some of the key compliance activities and challenges and shares GlaxoSmithKline's experiences and current practices.

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Assessing Compound Quality

Cited by 2 publications

References 31 publications

Analysis of Compound Weighing Precision in Drug Discovery

Analysis of Compound Weighing Precision in Drug Discovery

The Complexity of Compliance in Sample Management: A Review of Key Issues Impacting Small-Molecule and Biological Sample Management in Early Drug Discovery

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