Nonclinical safety assessment of vaccines: Up to date applications

Ülkü Karabay

doi:10.19161/etd.1542896

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AŞILARIN KLİNİK DIŞI GÜVENLİK DEĞERLENDİRMESİ: GÜNCEL UYGULAMALAR

Öz

Aşıların küresel sağlık üzerinde büyük etkisi vardır. Bu farmasötik ürünler, bebekleri ve çocukları da kapsayan sağlıklı bireylere uygulanan profilaktik ajanlardır. Bu nedenle klinik araştırmalara başlanmadan önce bunların güvenliğinin klinik öncesi çalışmalarla ortaya konması önemlidir. Klinik dışı değerlendirme, aşıların, adjuvanlanmış aşıların veya aşı adjuvanlarının hem in vitro hem de in vivo testlerini içeren ürün karakterizasyonunu içerir. İn vivo güvenlik çalışmaları farmakoloji çalışmalarını, farmakokinetik çalışmaları, genel toksisite çalışmalarını, gelişimsel ve üreme toksisitesini, genotoksisite ve karsinojenisite çalışmalarını ve immünojenisite değerlendirmesini kapsar. Bu testler İLU'ya uygun olarak yapılmalıdır. Hayvan modellerinde immün tepkiyi tetiklemek için güvenliği ve uygun dozu belirlemek amacıyla klinik dışı çalışmalar yürütülmektedir. Klinik dışı ve klinik toksisiteleri etkileyen birçok faktör nedeniyle her aşı için bir fayda-risk profili dikkate alınır. Bu derlemede aşıların toksisite testleri de dahil olmak üzere klinik dışı güvenlik değerlendirmesine odaklanılmıştır. Klinik dışı test gereklilikleri, aşıların güvenliğinin ve etkinliğinin belirlenmesinde önemli bir araçtır.

Anahtar Kelimeler

Nonclinical safety assessment of vaccines: Up to date applications

Abstract

Vaccines have a great impact on global health. These pharmaceutical products are prophylactic agents administered to healthy individuals, involving infants and children. Therefore, it is important to demonstrate the safety of them with nonclinical studies before the start of clinical trials. Nonclinical assessment includes product characterization, both in vitro and in vivo testing of vaccines, adjuvanted vaccines or vaccine adjuvants. In vivo safety studies contain pharmacology studies, pharmacokinetic studies, general toxicity studies, developmental and reproductive toxicity, genotoxicity and carcinogenicity studies, and immunogenicity assessment. These tests should be conducted in compliance with GLPs. Nonclinical studies are conducted to determine the safety and appropriate dose to induce an immune response in animal models. A benefit-to-risk profile is considered for each vaccine because of many factors that affect nonclinical and clinical toxicities. Herewith, the non-clinical safety evaluation of vaccines, including toxicity testing, has been focused. Nonclinical testing requirements are an essential tool to determination of the safety and efficacy of vaccines.

Keywords

Kaynakça

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Ülkü Karabay ^*
0000-0002-7483-0184
Türkiye

Yayımlanma Tarihi

9 Aralık 2024

Gönderilme Tarihi

3 Eylül 2024

Kabul Tarihi

1 Kasım 2024

Yayımlandığı Sayı

Yıl 2024 Cilt: 63 Sayı: 4

DOI

https://doi.org/10.19161/etd.1542896

IZ

https://izlik.org/JA33DS39ZS

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Vancouver

1.Ülkü Karabay. Nonclinical safety assessment of vaccines: Up to date applications. ETD. 01 Aralık 2024;63(4):644-59. doi:10.19161/etd.1542896