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An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors

Birth defects research. Part B. Developmental and reproductive toxicology, 2016-04, Vol.107 (2), p.108-119

2016

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Analysis of exposure margins in developmental toxicity studies for detection of human teratogens

Regulatory toxicology and pharmacology, 2019-07, Vol.105, p.62-68

2019

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Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection

Regulatory toxicology and pharmacology, 2019-10, Vol.107, p.104413, Article 104413

2019

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Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective

Regulatory toxicology and pharmacology, 2017-07, Vol.87, p.S1-S15

2017

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Role of chronic toxicology studies in revealing new toxicities

Regulatory toxicology and pharmacology, 2016-12, Vol.82, p.94-98

2016

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Carcinogenicity Testing and the Evaluation of Regulatory Requirements for Pharmaceuticals

Regulatory toxicology and pharmacology, 1997-04, Vol.25 (2), p.130-145

1997

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Characterization of an investigative safety pharmacology model to assess comprehensive cardiac function and structure in chronically instrumented conscious beagle dogs

Journal of pharmacological and toxicological methods, 2016-09, Vol.81, p.107-114

2016

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Safety Assessment of Drug Metabolites: Implications of Regulatory Guidance and Potential Application of Genetically Engineered Mouse Models that Express Human P450s

Chemical research in toxicology, 2009-02, Vol.22 (2), p.257-262

2009

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Applications of toxicogenomics to nonclinical drug development: regulatory science considerations

Methods in molecular biology (Clifton, N.J.), 2008, Vol.460, p.239

2008

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Considerations for Toxicology Studies of Respiratory Drug Products

Regulatory toxicology and pharmacology, 1997-04, Vol.25 (2), p.189-193

1997

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Use of Alternative Developmental Toxicity Assays to Assess Teratogenicity Potential of Pharmaceuticals

Applied in vitro toxicology, 2018-03, Vol.4 (1), p.44-53

2018

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Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans

Clinical pharmacology and therapeutics, 1996-03, Vol.59 (3), p.265-267

1996

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Regulatory considerations for preclinical development of anticancer drugs

Cancer chemotherapy and pharmacology, 1997-12, Vol.41 (3), p.173-185

1997

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In vivo brain incorporation of [1- 14C]arachidonate in awake rats, with or without cholinergic stimulation, following unilateral lesioning of nucleus basalis magnocellularis

Brain research, 1991-09, Vol.559 (1), p.1-9

1991

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Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies

Antisense research and development, 1994, Vol.4 (4), p.299-301

1994

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Differences in rates of incorporation of intravenously injected radiolabeled fatty acids into phospholipids of intracerebrally implanted tumor and brain in awake rats

Clinical & experimental metastasis, 1994-05, Vol.12 (3), p.213-225

1994

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Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs

Antisense research and development, 1993, Vol.3 (4), p.399-404

1993

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Intravenously injected radiolabelled fatty acids image brain tumour phospholipids in vivo: differential uptakes of palmitate, arachidonate and docosahexaenoate

Clinical & experimental metastasis, 1993-03, Vol.11 (2), p.141-149

1993

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Guidance for development of chemopreventive agents

Journal of cellular biochemistry, 1994, Vol.56 (S20), p.25-31

1994

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Synthesis of a fluorinated fatty acid, dl-erythro-9,10-[ 18F]difluoropalmitic acid, and biodistribution studies in rats

International journal of radiation applications and instrumentation. Part B, Nuclear medicine and biology, 1990, Vol.17 (8), p.805-809

1990

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Thematic and Demographic Analysis of Crowdsourcing Practices for Plastic Surgery

Annals of plastic surgery, 2023-05, Vol.90 (5), p.398-404

2023

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A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

Regulatory toxicology and pharmacology, 2006-04, Vol.44 (3), p.198-211

2006

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Importance of Halogen···Halogen Contacts for the Structural and Magnetic Properties of CuX 2 (pyrazine- N , N ′-dioxide)(H 2 O) 2 (X = Cl and Br)

Inorganic chemistry, 2012-02, Vol.51 (4), p.2121-2129

2012

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An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors

Analysis of exposure margins in developmental toxicity studies for detection of human teratogens

Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection

Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective

Role of chronic toxicology studies in revealing new toxicities

Carcinogenicity Testing and the Evaluation of Regulatory Requirements for Pharmaceuticals

Characterization of an investigative safety pharmacology model to assess comprehensive cardiac function and structure in chronically instrumented conscious beagle dogs

Safety Assessment of Drug Metabolites: Implications of Regulatory Guidance and Potential Application of Genetically Engineered Mouse Models that Express Human P450s

Applications of toxicogenomics to nonclinical drug development: regulatory science considerations

Considerations for Toxicology Studies of Respiratory Drug Products

Use of Alternative Developmental Toxicity Assays to Assess Teratogenicity Potential of Pharmaceuticals

Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans

Regulatory considerations for preclinical development of anticancer drugs

In vivo brain incorporation of [1- 14C]arachidonate in awake rats, with or without cholinergic stimulation, following unilateral lesioning of nucleus basalis magnocellularis

Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies

Differences in rates of incorporation of intravenously injected radiolabeled fatty acids into phospholipids of intracerebrally implanted tumor and brain in awake rats

Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs

Intravenously injected radiolabelled fatty acids image brain tumour phospholipids in vivo: differential uptakes of palmitate, arachidonate and docosahexaenoate

Guidance for development of chemopreventive agents

Synthesis of a fluorinated fatty acid, dl-erythro-9,10-[ 18F]difluoropalmitic acid, and biodistribution studies in rats

Thematic and Demographic Analysis of Crowdsourcing Practices for Plastic Surgery

Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study

A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

Left Ventricular Dysfunction in Murine Models of Heart Failure and in Failing Human Heart is Associated With a Selective Decrease in the Expression of Caveolin-3

Importance of Halogen···Halogen Contacts for the Structural and Magnetic Properties of CuX 2 (pyrazine- N , N ′-dioxide)(H 2 O) 2 (X = Cl and Br)

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