NSTL国家科技图书文献中心

1. Are Repeat-Dose Toxicity Studies Informative for Safety Assessment of Vaccine Candidates? A Survey of Vaccine Developers NSTL国家科技图书文献中心

Rohde, Cynthia M. | Destexhe, Eric ... - 《International journal of toxicology》 - 2025,44(1) - 3～11 - 共9页

摘要： repeat-dose toxicity studies for safety assessment of | performing repeat-dose* toxicity studies with vaccines* | indicated that repeat-dose* toxicity studies could be* | from the repeat-dose* toxicity studies never prevented* | replaced by a pharmacology study with additional toxicity

关键词： vaccine nonclinical safety | survey of industry practices | platform approach

2. Safety Assessment of Butyric Acid-Rich Triglyceride Oil: A Novel Palatable Formulation of Butyrate for the Pediatric Population NSTL国家科技图书文献中心

Watson, John A. | Nutten, Sophie ... - 《Journal of applied toxicology》 - 2025,45(3/4) - 587～605 - 共19页

摘要： rat repeat* dose toxicity study (OECD408), there were* | showed negative responses over the complete dose* range* | mg/kg/day dose* groups, respectively. No* | , gestation, or lactation periods at dose* levels up to and* | throughout the preweaning period at maternal dose* levels up*

关键词： health-related metabolites | in vivo models | nutrition | pediatric | short-chain fatty acids | toxicology | health‐related metabolites | short‐chain fatty acids

3. A phase I study of convection-enhanced delivery (CED) of liposomal-irinotecan using real-time magnetic resonance imaging in patients with recurrent high-grade glioma NSTL国家科技图书文献中心

Narsinh, Kazim H. | Kumar, Karishma ... - 《Journal of neuro-oncology.》 - 2025,172(1) - 219～227 - 共9页

摘要： dose-limiting toxicity (DLT) was a grade 3 stroke | glioma patients.MethodsInitially, a 3 + 3 dose | -escalating, single dose* trial was planned with 4 cohorts* | based on a fixed drug dose* and volume. After 9* | volume and dose* of the study agent based on tumor size*

关键词： Convection enhanced delivery | CED | Nano-liposomal irinotecan | MRI | Liposomal irinotecan | High grade gliomas | Glioblastoma | Gliosarcoma | Anaplastic astrocytoma | Oligodendroglioma...

4. Repeat dose and reproductive toxicity of thrombopoietin mimic peptide in Sprague-Dawley rats NSTL国家科技图书文献中心

Qiu, Shidong | Liang, Yuji ... - 《Regulatory Toxicology and Pharmacology》 - 2024,148 - 105581～105581 - 共12页

摘要： the potential toxicity of TMP in repeat-dose | . In repeat-dose* toxicity study, the rats were* | NOAEL of repeat-dose* toxicity in female rats is 5 mcg* | toxicity and reproductive/developmental toxicity studies | /kg. In the reproductive/developmental toxicity

关键词： Thrombopoietin mimic peptide | Receptor agonists | Repeat -dose toxicity | Developmental toxicity | Reproductive toxicity | Rats

5. Repeat-dose and embryo-fetal developmental toxicity of zinpentraxin alfa NSTL国家科技图书文献中心

Rao, Gautham K. | Santagostino, Sara F...... - 《Reproductive toxicology》 - 2024,123 - 108526～108526 - 共6页

摘要： investigation, we summarize findings from 14-day repeat-dose | toxicity studies in rats and cynomolgus monkeys | general toxicity* studies with no treatment-related* | same dose* range in a definitive EFD study. In* | contrast, substantial toxicity* was observed in a rabbit*

关键词： Zinpentraxin alfa | Pentraxin-2 | Maternal tolerability | Embryo-fetal development | Post-implantation fetal loss | Pregnancy risk | SERUM AMYLOID-P | C-REACTIVE PROTEIN | PULMONARY-FIBROSIS | INNATE IMMUNITY...

6. Bacillus subtilis ZB423: 90-Day repeat dose oral (gavage) toxicity study in Wistar rats NSTL国家科技图书文献中心

Vijayakumar, K. N. | Bamne, Swati S.... - 《Journal of applied toxicology》 - 2024,44(11/12) - 1874～1885 - 共12页

摘要：-dose* oral toxicity study adhering to Good Laboratory* | The novel genetically modified probiotic | Bacillus subtilis ZB423 was assessed in a 90-day repeated | Practice (GLP) and Organization for Economic Cooperation | and Development (OECD) guidelines. Spray-dried

关键词： B. subtilis ZB423 spores | food ingredient | safety | sub-chronic toxicity | Wistar rats | BACILLUS-SUBTILIS | LEVAN

7. Nonclinical safety and immunogenicity assessment of a combined DTacP vaccine in animal models NSTL国家科技图书文献中心

Li, Shihui | Fu, Hui ... - 《Journal of applied toxicology》 - 2024,44(11/12) - 1689～1699 - 共11页

摘要： systemic anaphylaxis study, and repeat-dose toxicity | -dose* toxicity study, where five intramuscular doses* | , potential toxicity, and local tolerance of the vaccine in | immunization dosage increased. In acute toxicity* study, no* | allergic reactions in the vaccine groups. In the repeat

关键词： animal models | DTacP vaccine | immunogenicity | nonclinical safety | toxicology | PERTUSSIS | ANAPHYLAXIS

8. Preclinical cardiovascular safety assessment of pharmacology-toxicology relationship for a set of novel kinase inhibitors NSTL国家科技图书文献中心

Koshman, Yevgeniya E... | Kohnken, Rebecca ... - 《Toxicological sciences: An official journal of the Society of Toxicology》 - 2024,198(2) - 316～327 - 共12页

摘要： in repeat-dose* toxicity studies. At the same doses* | dose and after 2-week and 4-week repeat dose studies | Cardiovascular toxicity* is one of the more* | lower the incidence of cardiovascular toxicity* that* | example of notable preclinical toxicity* is necrosis in*

关键词： kinase inhibitors | canine cardiovascular model | cardiovascular toxicity | preclinical safety | CARDIAC TROPONINS | DOGS | PATHOLOGY | CARDIOTOXICITY | MECHANISMS | MINOXIDIL...

9. Discovery of TRPA1 Antagonist GDC-6599 : Derisking Preclinical Toxicity and Aldehyde Oxidase Metabolism with a Potential First-in-Class Therapy for Respiratory Disease NSTL国家科技图书文献中心

Terrett, Jack A. | Ly, Justin Q.... - 《Journal of Medicinal Chemistry》 - 2024,67(5) - 3287～3306 - 共20页

摘要： preclinical single- and short-term repeat-dose toxicity | Transient receptor potential ankyrin 1 (TRPA1 | ) is a nonselective calcium ion channel highly | expressed in the primary sensory neurons, functioning as a | polymodal sensor for exogenous and endogenous stimuli, and

关键词： CHANNEL | RECEPTOR | PAIN | OPTIMIZATION | INFLAMMATION | ACTIVATION | COLD | INHIBITION | INSIGHTS | TARGET

10. Biodistribution and preclinical safety profile of legubicin: A novel conjugate of doxorubicin and a legumain‐cleavable peptide linker NSTL国家科技图书文献中心

Yan Wang | Liping Wei ... - 《Journal of applied toxicology》 - 2024,44(9/10) - 1426～1445 - 共20页

摘要： conventional doxorubicin is 1.5?mg/kg). Four‐week repeat‐dose | conventional doxorubicin at an equal molar dose* in mice, we* | legubicin. The acute maximum tolerance dose* (MTD) of* | toxicity studies of intravenous legubicin were conducted | in rats (5, 10, and 25?mg/kg/dose* once weekly) and*

摘要： repeat-dose toxicity studies for safety assessment of | performing repeat-dose* toxicity studies with vaccines* | indicated that repeat-dose* toxicity studies could be* | from the repeat-dose* toxicity studies never prevented* | replaced by a pharmacology study with additional toxicity

关键词： vaccine nonclinical safety | survey of industry practices | platform approach

摘要： rat repeat* dose toxicity study (OECD408), there were* | showed negative responses over the complete dose* range* | mg/kg/day dose* groups, respectively. No* | , gestation, or lactation periods at dose* levels up to and* | throughout the preweaning period at maternal dose* levels up*

关键词： health-related metabolites | in vivo models | nutrition | pediatric | short-chain fatty acids | toxicology | health‐related metabolites | short‐chain fatty acids

摘要： dose-limiting toxicity (DLT) was a grade 3 stroke | glioma patients.MethodsInitially, a 3 + 3 dose | -escalating, single dose* trial was planned with 4 cohorts* | based on a fixed drug dose* and volume. After 9* | volume and dose* of the study agent based on tumor size*

关键词： Convection enhanced delivery | CED | Nano-liposomal irinotecan | MRI | Liposomal irinotecan | High grade gliomas | Glioblastoma | Gliosarcoma | Anaplastic astrocytoma | Oligodendroglioma...

摘要： the potential toxicity of TMP in repeat-dose | . In repeat-dose* toxicity study, the rats were* | NOAEL of repeat-dose* toxicity in female rats is 5 mcg* | toxicity and reproductive/developmental toxicity studies | /kg. In the reproductive/developmental toxicity

关键词： Thrombopoietin mimic peptide | Receptor agonists | Repeat -dose toxicity | Developmental toxicity | Reproductive toxicity | Rats

摘要： investigation, we summarize findings from 14-day repeat-dose | toxicity studies in rats and cynomolgus monkeys | general toxicity* studies with no treatment-related* | same dose* range in a definitive EFD study. In* | contrast, substantial toxicity* was observed in a rabbit*

关键词： Zinpentraxin alfa | Pentraxin-2 | Maternal tolerability | Embryo-fetal development | Post-implantation fetal loss | Pregnancy risk | SERUM AMYLOID-P | C-REACTIVE PROTEIN | PULMONARY-FIBROSIS | INNATE IMMUNITY...

摘要：-dose* oral toxicity study adhering to Good Laboratory* | The novel genetically modified probiotic | Bacillus subtilis ZB423 was assessed in a 90-day repeated | Practice (GLP) and Organization for Economic Cooperation | and Development (OECD) guidelines. Spray-dried

关键词： B. subtilis ZB423 spores | food ingredient | safety | sub-chronic toxicity | Wistar rats | BACILLUS-SUBTILIS | LEVAN

关键词： animal models | DTacP vaccine | immunogenicity | nonclinical safety | toxicology | PERTUSSIS | ANAPHYLAXIS

摘要： in repeat-dose* toxicity studies. At the same doses* | dose and after 2-week and 4-week repeat dose studies | Cardiovascular toxicity* is one of the more* | lower the incidence of cardiovascular toxicity* that* | example of notable preclinical toxicity* is necrosis in*

关键词： kinase inhibitors | canine cardiovascular model | cardiovascular toxicity | preclinical safety | CARDIAC TROPONINS | DOGS | PATHOLOGY | CARDIOTOXICITY | MECHANISMS | MINOXIDIL...

摘要： preclinical single- and short-term repeat-dose toxicity | Transient receptor potential ankyrin 1 (TRPA1 | ) is a nonselective calcium ion channel highly | expressed in the primary sensory neurons, functioning as a | polymodal sensor for exogenous and endogenous stimuli, and

关键词： CHANNEL | RECEPTOR | PAIN | OPTIMIZATION | INFLAMMATION | ACTIVATION | COLD | INHIBITION | INSIGHTS | TARGET

关键词： conjugate of doxorubicin and a legumain‐cleavable peptide linker | doxorubicin | legumain | nonclinical safety | prodrug

4008-161-200 800-990-8900

国家科技图书文献中心

摘要： repeat-dose toxicity studies for safety assessment of | performing repeat-dose toxicity studies with vaccines | indicated that repeat-dose toxicity studies could be | from the repeat-dose toxicity studies never prevented | replaced by a pharmacology study with additional toxicity

关键词： vaccine nonclinical safety | survey of industry practices | platform approach

摘要： rat repeat dose toxicity study (OECD408), there were | showed negative responses over the complete dose range | mg/kg/day dose groups, respectively. No | , gestation, or lactation periods at dose levels up to and | throughout the preweaning period at maternal dose levels up

关键词： health-related metabolites | in vivo models | nutrition | pediatric | short-chain fatty acids | toxicology | health‐related metabolites | short‐chain fatty acids

摘要： dose-limiting toxicity (DLT) was a grade 3 stroke | glioma patients.MethodsInitially, a 3 + 3 dose | -escalating, single dose trial was planned with 4 cohorts | based on a fixed drug dose and volume. After 9 | volume and dose of the study agent based on tumor size

关键词： Convection enhanced delivery | CED | Nano-liposomal irinotecan | MRI | Liposomal irinotecan | High grade gliomas | Glioblastoma | Gliosarcoma | Anaplastic astrocytoma | Oligodendroglioma...

摘要： the potential toxicity of TMP in repeat-dose | . In repeat-dose toxicity study, the rats were | NOAEL of repeat-dose toxicity in female rats is 5 mcg | toxicity and reproductive/developmental toxicity studies | /kg. In the reproductive/developmental toxicity

关键词： Thrombopoietin mimic peptide | Receptor agonists | Repeat -dose toxicity | Developmental toxicity | Reproductive toxicity | Rats

摘要： investigation, we summarize findings from 14-day repeat-dose | toxicity studies in rats and cynomolgus monkeys | general toxicity studies with no treatment-related | same dose range in a definitive EFD study. In | contrast, substantial toxicity was observed in a rabbit

关键词： Zinpentraxin alfa | Pentraxin-2 | Maternal tolerability | Embryo-fetal development | Post-implantation fetal loss | Pregnancy risk | SERUM AMYLOID-P | C-REACTIVE PROTEIN | PULMONARY-FIBROSIS | INNATE IMMUNITY...

摘要：-dose oral toxicity study adhering to Good Laboratory | The novel genetically modified probiotic | Bacillus subtilis ZB423 was assessed in a 90-day repeated | Practice (GLP) and Organization for Economic Cooperation | and Development (OECD) guidelines. Spray-dried

关键词： B. subtilis ZB423 spores | food ingredient | safety | sub-chronic toxicity | Wistar rats | BACILLUS-SUBTILIS | LEVAN

摘要： systemic anaphylaxis study, and repeat-dose toxicity | -dose toxicity study, where five intramuscular doses | , potential toxicity, and local tolerance of the vaccine in | immunization dosage increased. In acute toxicity study, no | allergic reactions in the vaccine groups. In the repeat

关键词： animal models | DTacP vaccine | immunogenicity | nonclinical safety | toxicology | PERTUSSIS | ANAPHYLAXIS

摘要： in repeat-dose toxicity studies. At the same doses | dose and after 2-week and 4-week repeat dose studies | Cardiovascular toxicity is one of the more | lower the incidence of cardiovascular toxicity that | example of notable preclinical toxicity is necrosis in

关键词： kinase inhibitors | canine cardiovascular model | cardiovascular toxicity | preclinical safety | CARDIAC TROPONINS | DOGS | PATHOLOGY | CARDIOTOXICITY | MECHANISMS | MINOXIDIL...

摘要： preclinical single- and short-term repeat-dose toxicity | Transient receptor potential ankyrin 1 (TRPA1 | ) is a nonselective calcium ion channel highly | expressed in the primary sensory neurons, functioning as a | polymodal sensor for exogenous and endogenous stimuli, and

关键词： CHANNEL | RECEPTOR | PAIN | OPTIMIZATION | INFLAMMATION | ACTIVATION | COLD | INHIBITION | INSIGHTS | TARGET

关键词： conjugate of doxorubicin and a legumain‐cleavable peptide linker | doxorubicin | legumain | nonclinical safety | prodrug

4008-161-200 800-990-8900

国家科技图书文献中心

摘要： repeat-dose toxicity studies for safety assessment of | performing repeat-dose* toxicity studies with vaccines* | indicated that repeat-dose* toxicity studies could be* | from the repeat-dose* toxicity studies never prevented* | replaced by a pharmacology study with additional toxicity

摘要： rat repeat* dose toxicity study (OECD408), there were* | showed negative responses over the complete dose* range* | mg/kg/day dose* groups, respectively. No* | , gestation, or lactation periods at dose* levels up to and* | throughout the preweaning period at maternal dose* levels up*

摘要： dose-limiting toxicity (DLT) was a grade 3 stroke | glioma patients.MethodsInitially, a 3 + 3 dose | -escalating, single dose* trial was planned with 4 cohorts* | based on a fixed drug dose* and volume. After 9* | volume and dose* of the study agent based on tumor size*

摘要： the potential toxicity of TMP in repeat-dose | . In repeat-dose* toxicity study, the rats were* | NOAEL of repeat-dose* toxicity in female rats is 5 mcg* | toxicity and reproductive/developmental toxicity studies | /kg. In the reproductive/developmental toxicity

摘要： investigation, we summarize findings from 14-day repeat-dose | toxicity studies in rats and cynomolgus monkeys | general toxicity* studies with no treatment-related* | same dose* range in a definitive EFD study. In* | contrast, substantial toxicity* was observed in a rabbit*

摘要：-dose* oral toxicity study adhering to Good Laboratory* | The novel genetically modified probiotic | Bacillus subtilis ZB423 was assessed in a 90-day repeated | Practice (GLP) and Organization for Economic Cooperation | and Development (OECD) guidelines. Spray-dried

摘要： in repeat-dose* toxicity studies. At the same doses* | dose and after 2-week and 4-week repeat dose studies | Cardiovascular toxicity* is one of the more* | lower the incidence of cardiovascular toxicity* that* | example of notable preclinical toxicity* is necrosis in*