Nonclinical safety assessment of repeated administration and biodistribution of ChAd3‐EBO‐Z Ebola candidate vaccine
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DOI: 10.1002/jat.3941
Abstract: ChAd3‐EBO‐Z is an investigational adenovirus‐based vaccine for the prevention of Ebola virus disease. Two nonclinical studies were performed to evaluate the biodistribution, local tolerance and potential local and systemic toxic effects of this vaccine. In… read more here.
Keywords: safety assessment; biodistribution; assessment repeated; chad3 ebo ... See more keywords
Nonclinical safety evaluation of two vaccine candidates for herpes simplex virus type 2 to support combined administration in humans
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DOI: 10.1002/jat.4404
Abstract: Herpes simplex virus type 2 (HSV‐2) is the most common cause of genital disease worldwide. The development of an effective HSV‐2 vaccine would significantly impact global health based on the psychological distress caused by genital… read more here.
Keywords: simplex virus; nonclinical safety; virus type; two vaccine ... See more keywords
Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies.
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DOI: 10.1089/hum.2022.090
Abstract: The nonclinical safety assessments for gene therapies are evolving, leveraging over 20 years of experimental and clinical experience. Despite the growing experience with these therapeutics, there are no approved harmonized global regulatory documents for developing… read more here.
Keywords: safety; gene therapies; nonclinical safety; gene therapy ... See more keywords
The Nonclinical Safety Profile of GalNAc-conjugated RNAi Therapeutics in Subacute Studies
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DOI: 10.1177/0192623318792537
Abstract: Short interfering RNAs (siRNAs) and antisense oligonucleotides (ASOs) are the most clinically advanced oligonucleotide-based platforms. A number of N-acetylgalactosamine (GalNAc)-conjugated siRNAs (GalNAc-siRNAs), also referred to as RNA interference (RNAi) therapeutics, are currently in various stages… read more here.
Keywords: rnai therapeutics; galnac conjugated; safety; galnac sirnas ... See more keywords
Opinion on the Use of Animal Models in Nonclinical Safety Assessment: Pros and Cons
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DOI: 10.1177/01926233211003498
Abstract: Nonclinical evaluation of human safety risks for new chemical entities (NCEs) is primarily conducted in conventional healthy animals (CHAs); however, in certain instances, animal models of diseases (AMDs) can play a critical role in the… read more here.
Keywords: safety assessment; safety; pros cons; nonclinical safety ... See more keywords
Toxicologic Pathology Forum Opinion: Interpretation of Gliosis in the Brain and Spinal Cord Observed During Nonclinical Safety Studies.
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DOI: 10.1177/01926233231164557
Abstract: Gliosis, defined as a nonneoplastic reaction (hypertrophy and/or proliferation) of astrocytes and/or microglial cells, is a frequent finding in the central nervous system (CNS [brain and/or spinal cord]) in nonclinical safety studies. Gliosis in rodents… read more here.
Keywords: brain spinal; nonclinical safety; safety studies; pathology ... See more keywords
Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid™
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DOI: 10.1177/10915818221095489
Abstract: COVID-19 is a potentially fatal infection caused by the SARS-CoV-2 virus. The SARS-CoV-2 3CL protease (Mpro) is a viral enzyme essential for replication and is the target for nirmatrelvir. Paxlovid (nirmatrelvir co-administered with the pharmacokinetic… read more here.
Keywords: paxlovid; safety; pharmacology; development ... See more keywords