A Practical Approach, Second Edition=Ronald D. Ho.pdf

TERMINOLOGY OF ANATOMICAL DEFECTS 919The most convenient material available for initiating the process at the time the IFTS committeebegan its work was the glossary previously developed and distributed in the U.S.A. by the MiddleAtlantic Reproduction and Teratology Association (MARTA). A revision of this glossary wasunderway, in part, due to a request by the U.S. Food and Drug Administration for assistance intheir project to standardize submissions of data on new drugs. The effort to revise the MARTAglossary was initiated with the involvement of the Midwest Teratology Association (MTA). Aftera review by the IFTS Nomenclature Committee, the three organizations agreed to work jointly ondeveloping an international glossary. The glossary was revised in response to hundreds of commentsreceived from the initial request as well as comments from the IFTS committee and associatednomenclature committees in the UK, France, and Italy. The document presented herein representsconsiderable progress towards harmonization. Although not the product of a more formal internationalharmonization process such as ICH guideline development, this document is the first versionof an international glossary that will continue to evolve over the coming years with input fromworldwide IFTS members as well as other users of the glossary.We invite and would welcome questions, comments, additions, and suggestions of either a specificor general nature. Based on these comments and proposed modifications, an update of the glossarywill be initiated by the nomenclature committees. Specific or detailed comments and proposedchanges to the glossary may be directed to any author listed above, or, if not convenient, to Dr. L.David Wise (Merck Research Laboratories, W45-1, West Point, PA 19446; phone 215-652-6974;fax 215-652-3423; e-mail david_wise@merck.com). Comments or information regarding the overallIFTS initiative may be addressed to Dr. Carole A. Kimmel (U.S. Food and Drug Administration,NCTR [HFT-10] Rm. 16B-06, 5600 Fishers Lane, Rockville, MD 20857; phone 301-827-3403;fax 301-443-3019; e-mail ckimmel@nctr.fda.gov).Organization of the GlossaryThe terms included in the glossary describe morphological changes observed grossly or with theaid of a dissecting microscope in the most common laboratory animals used for developmentalstudies (mainly rats, mice, and rabbits). The term ‘abnormalities’ is used here as a collective termto mean differences from normal in the specimen under examination relative to the perceived normof control specimens for a particular species. It is perhaps not an ideal term since normality isrelative and may change over time, but is considered an acceptable term for this list.Terms are included which describe observations in fetal as well as neonatal animals. Thus, forexample, hypospadias and ocular coloboma, which are not readily detectable at birth in theseanimals, but are observable at some later time, are included in the glossary. On the other hand,cryptorchidism is not included as an observation, since the applicable event (descent of the testesinto the scrotum) does not occur until after weaning in these species. We sought to describeobservations of abnormalities with mainly descriptive terms and to avoid or limit terms that weremore diagnostic or perhaps implied mechanisms. Some observations may require follow-up studiesor examinations to determine more detail.The glossary is organized into broad sections for external, visceral, and skeletal observations,which reflect how the data are typically collected in developmental toxicity studies. The observationsare subdivided into regions, structures, or organs in a general overall head to tail sequence; theobservations within each are listed in alphabetical order. Some external observations are betterdefined with a subsequent visceral and/or skeletal examination, and these terms should then beassociated to reflect a single observation. The notes for external observations sometimes indicatewhere this is the case.Each term is sequentially numbered in this version in order to facilitate tracking of futurerevisions. These code numbers are not intended to provide any regional or hierarchical information.© 2006 by Taylor & Francis Group, LLC