Revision of ICH S8 Needed?

Laan, Jan Willem van der

doi:10.3389/ftox.2022.866737

Cited by 2 publications

(3 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The qualification threshold of individual peptide impurities is decided by virtue of their presence in the API during clinical trials and toxicology research. ICH S8 guidelines suggest immunotoxicity testing for pharmaceuticals; however, peptides and other biologics were not considered 12 . The USFDA final guidance provides recommendations for structural characterization and impurity level monitoring in synthetic generic peptides with respect to RLD 2 .…”

Section: Regulatory and Qc Considerations For Enantiomeric Impuritiesmentioning

confidence: 99%

Enantiomeric purity of synthetic therapeutic peptides: A review

Badgujar,

Paritala,

Matre

et al. 2024

Chirality

View full text Add to dashboard Cite

Synthetic therapeutic peptides are a complex and popular class of pharmaceuticals. In recent years, peptides with proven therapeutic activity have gained significant interest in the market. The determination of synthetic peptide enantiomeric purity plays a critical role in the evaluation of the quality of the medicine. Since racemization is one of the most common side reactions occurring in AAs or peptides, enantiomeric impurities such as D‐isomers can form during the peptide synthesis or can be introduced from the starting materials (e.g., AAs). The therapeutic effect of a synthetic or semi‐synthetic bioactive peptide molecule depends on its AA enantiomeric purity and secondary/tertiary structure. Therefore, the enantiomeric purity determination for synthetic peptides is supportive for interpreting unwanted therapeutic effects and determining the quality of synthetic peptide therapeutics. However, enantiomeric purity analysis encounters formidable analytical challenges during chromatographic separation, as D/L isomers have identical physical–chemical properties except stereochemical configuration. To ensure peptides AA stereochemical configuration whether in the free or bound state, sensitive and reproducible quantitative analytical method is mandatory. In this regard, numerous analytical techniques were emerged for the quantification of D‐isomeric impurities in synthetic peptides, but still, very few reports are available in the literature. Thus, the purpose of this paper is to provide an overview of the importance, regulatory requirements, and various analytical methods used for peptide enantiomeric purity determination. In addition, we discussed the available literature in terms of enantiomeric impurity detection, common hydrolysis procedural aspects, and different analytical strategies used for sample preparation.

show abstract

Section: Regulatory and Qc Considerations For Enantiomeric Impuritiesmentioning

confidence: 99%

Enantiomeric purity of synthetic therapeutic peptides: A review

Badgujar,

Paritala,

Matre

et al. 2024

Chirality

View full text Add to dashboard Cite

show abstract

“…All human pharmaceuticals pass through a regulated process and must demonstrate safety in immunotoxicity studies prior to clinical trials 65 ; however, there are limitations to pre-clinical testing for immunosuppressant risk. 66 While profound immunosuppression carries intrinsic risk when the immune system is less able to detect and destroy cancer cells and oncogenic viruses, risk for cancer following exposure to immunosuppression is most strongly associated with patient characteristics at the time of treatment. 67,68 Traditional systemics for AD are considered non-selective immunosuppressants, and their pharmacologic activity may pose a hazard for developing specific cancer types.…”

Section: % Agreementmentioning

confidence: 99%

“…While data from phase 3 clinical trials of systemic treatments for AD show no signals for increased cancer rates (Table S6), these studies do not have sufficient follow‐up time and are underpowered to detect alteration of cancer incidence. All human pharmaceuticals pass through a regulated process and must demonstrate safety in immunotoxicity studies prior to clinical trials 65 ; however, there are limitations to pre‐clinical testing for immunosuppressant risk 66 . While profound immunosuppression carries intrinsic risk when the immune system is less able to detect and destroy cancer cells and oncogenic viruses, risk for cancer following exposure to immunosuppression is most strongly associated with patient characteristics at the time of treatment 67,68 …”

Section: Data Summariesmentioning

confidence: 99%

Expert consensus on the systemic treatment of atopic dermatitis in special populations

Adam

Gooderham

Beecker

et al. 2023

Acad Dermatol Venereol

View full text Add to dashboard Cite

With the increasing number of options for the treatment of moderate-to-severe atopic dermatitis, clinicians need guidance on a practical approach to selecting a systemic agent for specific patient populations. We convened an expert panel consisting of 12 members to conduct a literature review and summarize relevant data related to six scenarios of clinical interest: comorbid asthma, ocular surface disease, history of cancer, past and ongoing infections of interest (including herpes simplex virus, herpes zoster, hepatitis B, and tuberculosis), pregnancy and lactation, and the elderly. We performed a literature search and examined each clinical scenario with | 1143 ADAM et al.

show abstract

Revision of ICH S8 Needed?

Cited by 2 publications

References 20 publications

Enantiomeric purity of synthetic therapeutic peptides: A review

Enantiomeric purity of synthetic therapeutic peptides: A review

Expert consensus on the systemic treatment of atopic dermatitis in special populations

Contact Info

Product

Resources

About