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Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals

Regulatory toxicology and pharmacology, 2023-09, Vol.143, p.105449-105449, Article 105449

2023

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IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

Toxics (Basel), 2022-05, Vol.10 (5), p.232

2022

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Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future

Regulatory toxicology and pharmacology, 2021-07, Vol.123, p.104953-104953, Article 104953

2021

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An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Regulatory toxicology and pharmacology, 2020-07, Vol.114, p.104662, Article 104662

2020

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Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies

Regulatory toxicology and pharmacology, 2023-03, Vol.139, p.105345-105345, Article 105345

2023

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Regulatory Forum Opinion Piece: Transgenic/Alternative Carcinogenicity Assays: A Retrospective Review of Studies Submitted to CDER/FDA 1997–2014

Toxicologic pathology, 2015-07, Vol.43 (5), p.605-610

2015

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Regulatory Perspectives on Juvenile Animal Toxicologic Pathology

Toxicologic pathology, 2021-12, Vol.49 (8), p.1393-1404

2021

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Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro

Toxicology in vitro, 2023-09, Vol.91 (C), p.105630-105630, Article 105630

2023

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Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate)

ALTEX, alternatives to animal experimentation, 2022, Vol.39 (2), p.297

2022

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CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

The AAPS journal, 2013-07, Vol.15 (3), p.623-628

2013

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CDER Photosafety Guidance for Industry

Toxicologic pathology, 2004-07, Vol.32 (2_suppl), p.17-18

2004

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Potential value of animal microphysiological systems

ALTEX, alternatives to animal experimentation, 2024-08

2024

Volltextzugriff (PDF)

Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro

Toxicology in vitro, 2023-09, Vol.91 (C)

2023

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Chemical Processes for Pollution Prevention and Control

1st edition., 2018

Volltextzugriff (PDF)

Person Identification From Text Independent Lip Movement Using the Longest Matching Segment Method

International journal of computer science issues, 2017-07, Vol.14 (4), p.1-7

2017

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Visual-only person and word recognition: from lip motion dynamics

Brown, Paul C

2017

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Toward a Healthcare Business-Process Reference Model

IT professional, 2011-05, Vol.13 (3), p.38-47

2011

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Computers and Creativity

1. Aufl., 2012

Volltextzugriff (PDF)

A Concept Representation Language (CRL)

2018 IEEE 12th International Conference on Semantic Computing (ICSC), 2018, p.1-8

Brown, Paul C.

2018

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Cost Engineering for Pollution Prevention and Control

1, 2021

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Hepatic spiral CT: reduction of dose of intravenous contrast material

Radiology, 1995-10, Vol.197 (1), p.83

1995

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Cloning and regulation of the rat mdr2 gene

Nucleic acids research, 1993-08, Vol.21 (16), p.3885-3891

1993

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R (on the application of Lisle-Mainwaring) v Isleworth Crown Court and another

The Estates Gazette, 2017-05, p.76

2017

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Regulation of mdr1b gene expression in Fischer, Wistar and Sprague-Dawley rats in vivo and in vitro

Carcinogenesis (New York), 1996-03, Vol.17 (3), p.451-457

1996

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Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals

IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies

Regulatory Forum Opinion Piece: Transgenic/Alternative Carcinogenicity Assays: A Retrospective Review of Studies Submitted to CDER/FDA 1997–2014

Regulatory Perspectives on Juvenile Animal Toxicologic Pathology

Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro

Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate)

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

CDER Photosafety Guidance for Industry

Potential value of animal microphysiological systems

Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro

Chemical Processes for Pollution Prevention and Control

Person Identification From Text Independent Lip Movement Using the Longest Matching Segment Method

Visual-only person and word recognition: from lip motion dynamics

Toward a Healthcare Business-Process Reference Model

Computers and Creativity

A Concept Representation Language (CRL)

Cost Engineering for Pollution Prevention and Control

Hepatic spiral CT: reduction of dose of intravenous contrast material

Cloning and regulation of the rat mdr2 gene

Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate)

R (on the application of Lisle-Mainwaring) v Isleworth Crown Court and another

Regulation of mdr1b gene expression in Fischer, Wistar and Sprague-Dawley rats in vivo and in vitro

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