Animal models in the evaluation of antimicrobial agents

Zak, O.; O’Reilly, Terence

doi:10.1128/aac.35.8.1527

Cited by 66 publications

(48 citation statements)

References 35 publications

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“…Serious consideration was given to the discovery of effective agents that could be used to cure and prevent this disease, especially in AIDS patients. In the battery of investigations for the identification of new chemotherapeutic agents, in vivo tests with suitable animal models assume great importance as predictors of chemotherapeutic efficacy and safety (1,14,100,101). Until recently, proper in vivo studies to discover drugs active against MAC could not be done for want of a suitable animal model (11,28,29).…”

Section: Introductionmentioning

confidence: 99%

Beige mouse model for Mycobacterium avium complex disease

Gangadharam

1995

Antimicrob Agents Chemother

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Section: Introductionmentioning

confidence: 99%

Beige mouse model for Mycobacterium avium complex disease

Gangadharam

1995

Antimicrob Agents Chemother

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“…Four comprehensive reviews [5,[55][56][57] provide examples of how animal models of disease can provide beneficial information on potential toxicities for diseased patients. Individual articles also highlight the potential benefits for conducting nonclinical safety evaluations in animal disease models for biopharmaceuticals [5,[55][56][57][58][59], oncology [60], Alzheimer's disease [61] and antimicrobial agents [62]. The use of animal disease models for safety evaluation of biotechnology-derived pharmaceuticals is also supported by the ICH S6 Guidance, which indicates certain cases may warrant the use of animal models of disease as acceptable alternatives to toxicity studies in normal healthy animals.…”

Section: Therapeutic Vaccinesmentioning

confidence: 98%

Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models

Dixit¹,

Iciek²,

McKeever³

et al. 2009

Expert Opinion on Drug Discovery

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While there is fair concordance for small molecules, animal models used for the safety evaluation of biologics may have limitations with regard to human relevance. For small molecules, this is commonly because of differences in metabolism profiles or off-target effects. For biologics, which are highly targeted molecules, it may be because of differences in physiological processes or biologic pathways that limit pharmacologic relevance. For vaccines or immunomodulatory biologics, it may be related to the complexities of modeling the human immune system in a nonhuman species. While international guidances are available to govern the nonclinical safety assessment process for human pharmaceuticals (such as ICH M3), in many instances a case-by-case approach is employed for novel agents.

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“…8 However, a comprehensive review of the animal models of external traumatic wound infections has never been conducted. In this review, we will discuss the animal models of infected external traumatic *Correspondence to: Michael R. Hamblin; Email: hamblin@helix.mgh.harvard.edu Submitted: 04/29/11; Revised: 06/07/11; Accepted: 06/08/11 DOI: 10.4161/viru.…”

Section: Introductionmentioning

confidence: 99%