Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies

Parris, Patricia; Martin, Elizabeth A.; Stanard, Brad; Glowienke, Susanne; Dolan, David G.; Li, Kim; Binazon, Ornella; Giddings, Amanda; Whelan, Geraldine; Masuda-Herrera, Melisa; Bercu, Joel P.; Broschard, Thomas H.; Bruen, Uma; Callis, Courtney M.; Stults, Cheryl L. M.; Erexson, Gregory L.; Cruz, Maureen T.; Nagao, Lee M.

doi:10.1016/j.yrtph.2020.104802

Cited by 10 publications

(1 citation statement)

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“…The ELSIE consortium is considering ways to collaboratively generate PDEs for the E&L substances held within the database; to date this has been applied to 2 commonly occurring leachables where oral and iv limits were developed. 43 A further publication by Parris et al 44 derives PDEs for common E&Ls such as butylated hydroxytoluene, Irganox 1010, and Irgafos 168.…”

Section: Discussionmentioning

confidence: 99%

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

et al. 2021

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A workshop entitled “Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis” was held at the 2018 Genetic Toxicology Association annual meeting. The objectives of the workshop were to provide an educational forum and use case studies and live multiple-choice polling to establish the degree of similarity/diversity in approach/opinion of the industry experts and other delegates present for some of the more challenging decision points that need to be considered when developing a compound-specific exposure limit (ie, acceptable intake or permissible or permitted daily exposure). Herein we summarize the relevant background and case study information for each decision point topic presented as well as highlight significant polling responses and discussion points. A common observation throughout was the requirement for expert judgment to be applied at each of the decision points presented which often results in different reasoning being applied by the risk assessor when deriving a compound-specific exposure limit. This supports the value of precompetitive cross-industry collaborations to develop compound-specific limits and harmonize the methodology applied, thus reducing the associated uncertainty inherent in the application of isolated expert judgment in this context. An overview of relevant precompetitive cross-industry collaborations working to achieve this goal is described.

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Section: Discussionmentioning

confidence: 99%

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

et al. 2021

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Occupational Toxicology in the Pharmaceutical Industry

Dolan

Bercu

Graham³

et al. 2023

Patty's Toxicology

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Much of the activity in the pharmaceutical industry has its origins in the fine chemicals industry of the late nineteenth century. At that time, advances in chemistry and medicine led to the manufacture of pharmacologically active small molecules to produce desirable biological effects to treat diseases and illnesses at relatively low doses. Advances in biology and chemistry in the past quarter century have led to an increase in innovation resulting in a variety of novel modalities, especially recombinant proteins, antibody‐drug conjugates, cell and gene therapies, peptides and polypeptides, oligonucleotides, and vaccines. The roles and responsibilities of occupational toxicologists in the pharmaceutical industry have expanded dramatically in the twenty‐first century, commensurate with the changing regulatory requirements and treatment modalities. The occupational toxicologists' roles have become increasingly multidisciplinary and the scope of their involvement has expanded to encompass diverse aspects of worker safety as well as patient safety, and to include involvement throughout a molecule's development, from early development through postcommercialization.

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General Principles for Risk Assessment of Extractables and Leachables

2022

Extractables and Leachables

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Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies

Cited by 10 publications

References 53 publications

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

Occupational Toxicology in the Pharmaceutical Industry

General Principles for Risk Assessment of Extractables and Leachables

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