Histomorphometric evaluation of the Göttingen minipig eye

Shrader, Stephanie; Mowry, Richard N

doi:10.1111/vop.12665

Cited by 7 publications

(5 citation statements)

References 30 publications

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“…Microbial and host-cell impurities (e.g., βglucan and nucleic acids) activate the innate immune sensors (e.g., pattern recognition receptors and damage-associated T A B L E 1 Notable species-specific differences in ocular anatomy in healthy adults. 11,74,85,[112][113][114][115][116][117][118][119][120][121][122][123][124] Anatomic features…”

Section: Biophysical Properties Of the Drug Product Potentially Impac...mentioning

confidence: 99%

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

Pruimboom‐Brees

Gupta

Chemuturi

et al. 2023

Clinical Translational Sci

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The eye, which is under constant exposure to environmental pathogens, has evolved various anatomic and immunological barriers critical to the protection of tissues lacking regenerative capacity, and the maintenance of a clear optic pathway essential to vision. By bypassing the ocular barriers, intravitreal (IVT) injection has become the mainstay for the delivery of drugs to treat conditions that affect the back of the eye. Both small molecules and biotherapeutics have been successfully administered intravitreally, and several drugs have been approved for the treatment of (wet) age-related macular degeneration and diabetic macular edema. However, IVT injection is an invasive procedure, which requires sufficient technical expertise from the healthcare professional administering the drug.Potential side effects include bleeding, retinal tear, cataracts, infection, uveitis, loss of vision, and increased ocular pressure. Pharmaceutical companies often F I G U R E 1 Structures and compartments of the eye. 19 Hematoxylin-eosin-stained section of a whole dog eye. The anterior segment is divided into the anterior and posterior chambers, which are anatomically delineated by the AH; cornea, sclera, and conjunctiva; ICA; the ciliary processes, and iris body. Behind the lens, the posterior segment includes the VB; retina and ora serrata; the choroid and sclera; and the optic nerve.

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Section: Biophysical Properties Of the Drug Product Potentially Impac...mentioning

confidence: 99%

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

Pruimboom‐Brees

Gupta

Chemuturi

et al. 2023

Clinical Translational Sci

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“…Continuous efforts are being made to better characterize the (juvenile) pig in the fields of ophthalmology [ 251 , 252 ], neurodevelopment [ 28 ], immunology [ 28 ], and drug absorption, metabolism and toxicity [ 35 , 43 , 45 , 253 , 254 , 255 , 256 ], although there is still evidence supporting the need for more background information in pigs [ 253 ]. Moreover, differences in between breeds exist [ 257 ] and, since fully characterizing all the pig breeds available is a long-term task, most efforts concentrate in studying the most used pig breed in pharmacological studies in Europe, the Göttingen Minipig [ 35 , 43 , 44 , 45 , 258 , 259 , 260 , 261 , 262 , 263 , 264 , 265 , 266 , 267 , 268 , 269 , 270 , 271 , 272 , 273 , 274 ]. Inter-breed differences are magnified due to the lack of standardization regarding food and feeding patterns, age and sex of pigs used in research [ 275 ].…”

Section: Pitfalls Limitations and Unexplored Areas Of The Modelmentioning

confidence: 99%

The Neonatal and Juvenile Pig in Pediatric Drug Discovery and Development

et al. 2020

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Pharmacotherapy in pediatric patients is challenging in view of the maturation of organ systems and processes that affect pharmacokinetics and pharmacodynamics. Especially for the youngest age groups and for pediatric-only indications, neonatal and juvenile animal models can be useful to assess drug safety and to better understand the mechanisms of diseases or conditions. In this respect, the use of neonatal and juvenile pigs in the field of pediatric drug discovery and development is promising, although still limited at this point. This review summarizes the comparative postnatal development of pigs and humans and discusses the advantages of the juvenile pig in view of developmental pharmacology, pediatric diseases, drug discovery and drug safety testing. Furthermore, limitations and unexplored aspects of this large animal model are covered. At this point in time, the potential of the neonatal and juvenile pig as nonclinical safety models for pediatric drug development is underexplored.

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“…With the growing popularity of minipigs in ocular research and drug development, there are numerous recent minipig publications useful for pathologists and toxicologists involved in ocular toxicity studies. Recent publications with relevance to ocular toxicity studies in minipigs, primarily Göttingen minipigs, include basic ocular histomorphometry, 41 pre- and postnatal development of the eye, 42 ocular immunohistochemistry and in situ hybridization biomarkers, 43 electroretinography (ERG), 44 and optical coherence tomography (OCT). 43,45 Immunology 46 and ocular immunogenicity testing 47 of minipigs has been characterized, and although the minipig may be suitable for biologics, this species can mount a substantial immunogenic response to human proteins.…”

Section: Ocular Toxicity Studies: Selecting a Cro Study Designs Andmentioning

confidence: 99%

Selected Aspects of Ocular Toxicity Studies With a Focus on High-Quality Pathology Reports: A Pathology/Toxicology Consultant’s Perspective

Short¹

2020

Toxicol Pathol

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Ocular toxicity studies are the bedrock of nonclinical ocular drug and drug–device development, and there has been an evolution in experience, technologies, and challenges to address that ensures safe clinical trials and marketing authorization. The expectations of a well-designed ocular toxicity study and the generation of a coherent, integrative ocular toxicology report and subreports are high, and this article provides a pathology/toxicology consultant’s perspective on achieving that goal. The first objective is to cover selected aspects of study designs for ocular toxicity studies including considerations for contract research organization selection, minipig species selection, unilateral versus bilateral dosing, and in-life parameters based on fit-for-purpose study objectives. The main objective is a focus on a high-quality ocular pathology report that includes ocular histology procedures to meet regulatory expectations and a report narrative and tables that correlate microscopic findings with key ophthalmic findings and presents a clear interpretation of test article-, vehicle-, and procedure-related ocular and extraocular findings with identification of adversity and a pathology peer review. The last objective covers considerations for a high-quality ophthalmology report, which in concert with a high-quality pathology report, will pave the way for a best quality toxicology report for an ocular toxicity study.

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Histomorphometric evaluation of the Göttingen minipig eye

Cited by 7 publications

References 30 publications

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

The Neonatal and Juvenile Pig in Pediatric Drug Discovery and Development

Selected Aspects of Ocular Toxicity Studies With a Focus on High-Quality Pathology Reports: A Pathology/Toxicology Consultant’s Perspective

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