A proposal for an alternative approach to particle size method development during early stage small molecule pharmaceutical development.

A proposal for an alternative approach to particle size method development during early stage small molecule pharmaceutical development.

Gamble, John F;Dawson, Neil;Murphy, Dean;Theophilus, Andrew;Kippax, Paul;
journal of pharmaceutical sciences 2019
260
gamble2019ajournal

Abstract

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a 'true' value for the size of a particle can be challenging as the output of its measurement will differ due to variations in measurement approaches, instrumental differences and calculation methods. Consequently, for 'real' particles, a universal 'true' value does not exist and accuracy is therefore not a useful characteristic. Accordingly, precision is then a measure of the ability to reproducibly measure of value of unknown value. This paper proposes, in place of accuracy, a means to define the 'appropriateness' of a measurement in line with the Critical Quality Attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQAs; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a Critical Material Attribute (CMA). Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.

Citation

ID: 17567
Ref Key: gamble2019ajournal
Use this key to autocite in SciMatic or Thesis Manager

References

Blockchain Verification

Account:
NFT Contract Address:
0x95644003c57E6F55A65596E3D9Eac6813e3566dA
Article ID:
17567
Unique Identifier:
S0022-3549(19)30503-9
Network:
Scimatic Chain (ID: 481)
Loading...
Blockchain Readiness Checklist
Authors
Abstract
Journal Name
Year
Title
5/5
Creates 1,000,000 NFT tokens for this article
Token Features:
  • ERC-1155 Standard NFT
  • 1 Million Supply per Article
  • Transferable via MetaMask
  • Permanent Blockchain Record
Blockchain QR Code
Scan with Saymatik Web3.0 Wallet

Saymatik Web3.0 Wallet