Teratogenicity Testing

Methods and Protocols

Editors:

ISBN: 978-1-62703-130-1 (Print) 978-1-62703-131-8 (Online)

Table of contents (36 protocols)

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  1. Front Matter

    Pages i-xiv

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    Pages 1-11

    The ICH S5(R2) Guideline for the Testing of Medicinal Agents

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    Pages 13-30

    Nonclinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China

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    Pages 31-36

    The Developmental Toxicity Testing of Biologics

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    Pages 37-56

    The OECD Guidelines for the Testing of Chemicals and Pesticides

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    Pages 57-72

    Teratology Testing Under REACH

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    Pages 73-80

    The Teratology Testing of Food Additives

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    Pages 81-89

    Developmental Toxicity Testing of Vaccines

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    Pages 91-94

    The Teratology Testing of Cosmetics

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    Pages 95-109

    Teratology Studies in the Rat

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    Pages 111-123

    Teratology Studies in the Mouse

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    Pages 125-137

    Combined Fertility and Embryotoxicity Study

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    Pages 139-156

    Teratology Studies in the Rabbit

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    Pages 157-167

    Teratology Studies in the Minipig

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    Pages 169-183

    Embryo fetal Development Studies in Nonhuman Primates

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    Pages 185-200

    The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies

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    Pages 201-213

    Skeletal Examination by Alizarin Staining

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    Pages 215-221

    Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue

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    Pages 223-231

    Small Animal Imaging and Examination by Micro-CT

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    Pages 233-242

    Fetal Soft Tissue Examination by Serial Sectioning

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    Pages 243-253

    Fetal Soft Tissue Examinations by Microdissection

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