Abstract
Birth defects and other adverse outcomes of pregnancy have been known since before the industrial age, but the need for guidelines to test chemicals to which pregnant women might be exposed was defined by the thalidomide tragedy in the 1950s and early 1960s. During the five decades that followed the tragedy, guidelines were written to test drugs, foods, and environmental contaminants. The guidelines were written to fulfill national needs, and then were expanded to international levels in order to streamline procedures in the expanding global economy. Multiple sets of animal guidelines were written, based on the need to simulate human experience. It was soon realized that the underlying principles were similar for all guidelines. Guidelines gradually evolved in two directions, in complexity and number of endpoints measured and in the expansion of internationally acceptable guidelines. This manuscript reviews, in chronological order, some of the milestones in the development of guidelines for animal studies and in the interpretations for safety assessment. Guidelines for long-term and short-term studies are reviewed, followed by a discussion of recently added endpoints and the future integration process for the assessment of reproductive toxicity risk.
Keywords: teratology, reproduction, Guidelines
Current Pharmaceutical Design
Title: History and Evolution of Reproductive and Developmental Toxicology Guidelines
Volume: 12 Issue: 12
Author(s): Thomas F.X. Collins
Affiliation:
Keywords: teratology, reproduction, Guidelines
Abstract: Birth defects and other adverse outcomes of pregnancy have been known since before the industrial age, but the need for guidelines to test chemicals to which pregnant women might be exposed was defined by the thalidomide tragedy in the 1950s and early 1960s. During the five decades that followed the tragedy, guidelines were written to test drugs, foods, and environmental contaminants. The guidelines were written to fulfill national needs, and then were expanded to international levels in order to streamline procedures in the expanding global economy. Multiple sets of animal guidelines were written, based on the need to simulate human experience. It was soon realized that the underlying principles were similar for all guidelines. Guidelines gradually evolved in two directions, in complexity and number of endpoints measured and in the expansion of internationally acceptable guidelines. This manuscript reviews, in chronological order, some of the milestones in the development of guidelines for animal studies and in the interpretations for safety assessment. Guidelines for long-term and short-term studies are reviewed, followed by a discussion of recently added endpoints and the future integration process for the assessment of reproductive toxicity risk.
Export Options
About this article
Cite this article as:
Collins F.X. Thomas, History and Evolution of Reproductive and Developmental Toxicology Guidelines, Current Pharmaceutical Design 2006; 12 (12) . https://dx.doi.org/10.2174/138161206776389813
DOI https://dx.doi.org/10.2174/138161206776389813 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Inorganic Phosphate as a Signaling Molecule: A Potential Strategy in Osteosarcoma Treatment
Current Pharmaceutical Design Obesity and Arterial Compliance Alterations
Current Vascular Pharmacology OMICS-Derived Targets for Inflammatory Gut Disorders: Opportunities for the Development of Nutrition Related Biomarkers
Endocrine, Metabolic & Immune Disorders - Drug Targets Meet Our Editorial Board Member
Current Cancer Therapy Reviews Hepatic Steatosis and Peroxisomal Fatty Acid Beta-oxidation
Current Drug Metabolism Experimental Drugs for Neuropathic Pain
Current Neuropharmacology Angiogenic and Antiangiogenic Factors in Proliferative Diabetic Retinopathy
Current Diabetes Reviews Radiochemical Evaluation and <i>In Vitro</i> Assessment of the Targeting Ability of a Novel <sup>99m</sup>Tc-HYNIC-RGD for U87MG Human Brain Cancer Cells
Current Radiopharmaceuticals Fertility Preservation in Women After the Cancer
Current Pharmaceutical Design Thymulin: An Emerging Anti-Inflammatory Molecule
Current Medicinal Chemistry - Anti-Inflammatory & Anti-Allergy Agents Cause and Consequences of Genetic and Epigenetic Alterations in Human Cancer
Current Genomics Recent Advances in the Rationale Design of GPER Ligands
Current Medicinal Chemistry Sympathetic Signaling in Angiogenesis: Implications for Cancer Progression
Current Cancer Therapy Reviews Gut Microbiota of Obese, Type 2 Diabetic Individuals is Enriched in Faecalibacterium prausnitzii, Akkermansia muciniphila and Peptostreptococcus anaerobius after Weight Loss
Endocrine, Metabolic & Immune Disorders - Drug Targets Bombesin-like Peptides: Candidates as Diagnostic and Therapeutic Tools
Current Pharmaceutical Design Recent Progress in Phosphoinositide 3-Kinases: Oncogenic Properties and Prognostic and Therapeutic Implications
Current Protein & Peptide Science Anti-obesity Agents: A Focused Review on the Structural Classification of Therapeutic Entities
Current Topics in Medicinal Chemistry The c-Met Inhibitors: A New Class of Drugs in the Battle Against Advanced Nonsmall- Cell Lung Cancer
Current Pharmaceutical Design Editorial
Current Medicinal Chemistry - Immunology, Endocrine & Metabolic Agents Acute and Chronic Stress-Induced Disturbances of Microglial Plasticity, Phenotype and Function
Current Drug Targets