Animal Study Protocols and Alternative Assays for the Assessment of Reproductive and Developmental Toxicity

2015 ◽  
pp. 178-203
Keyword(s):  
Animal Study ◽  
Developmental Toxicity ◽  
Study Protocols

scholarly journals Utility of generational developmental and reproductive toxicity and juvenile animal study protocols for the infant safety assessment of food contact materials

2018 ◽  
Vol 2 ◽  
pp. 239784731880604
Author(s):  
April Neal-Kluever ◽  
Queenster Nartey ◽  
Jason Aungst ◽  
Federica Basso ◽  
Karen Davis-Bruno ◽  
...  
Keyword(s):  
Animal Study ◽  
Safety Assessment ◽  
Food Additives ◽  
Chemical Exposure ◽  
Contact Materials ◽  
Food Contact Materials ◽  
Food Contact ◽  
Juvenile Animal ◽  
Study Protocols ◽  
Infant Safety

The US Food and Drug Administration (FDA) Division of Food Contact Notifications (DFCN) performs infant lifestage-specific exposure and safety assessments during the premarket review of FCNs proposed for use with infant formula or human milk. DFCN previously identified two protocols that may be best suited to support infant safety: the multigenerational developmental and reproductive toxicology (Gen-DART) protocol and the juvenile animal study (JAS) protocol. The Gen-DART protocol tests chemical exposure from prior to mating through one or two generations in rodents, while JAS protocols test a chemical during a specific developmental window. At FDA, Gen-DART studies are currently recommended to support the safety of food additives (FAs), including food contact substances, across lifestages (from conception through adulthood). JAS protocols are recommended in the nonclinical safety assessment of drugs seeking pediatric indications. To improve our recommendations regarding the use of either Gen-DART or JAS protocols for the infant safety assessment of food contact materials, we created a database of FDA-reviewed Gen-DART or JAS. Our database contains information from 41 Gen-DART studies (38 FAs) and 51 JAS (29 drugs). Both protocols can detect toxicity relevant to infant safety assessment, such as developmental toxicity in neurological, endocrine, reproductive, immunological, or skeletal systems. Selection of either protocol will depend on the amount of information available for the chemical under study. The Gen-DART protocol may be preferred when limited data on the mode of action or target organ of the chemical are available. However, if these data are available, a JAS may provide the best assessment of potential juvenile toxicity.

scholarly journals Publication rate in preclinical research: a plea for preregistration

2020 ◽  
Vol 4 (1) ◽  
pp. e100051 ◽  
Author(s):  
Mira van der Naald ◽  
Steven Wenker ◽  
Pieter A Doevendans ◽  
Kimberley E Wever ◽  
Steven A J Chamuleau
Keyword(s):  
Animal Study ◽  
Medical Center ◽  
Large Fraction ◽  
Treatment Options ◽  
Publication Rate ◽  
Preclinical Research ◽  
Study Protocols ◽  
Protocol Registration ◽  
New Treatment ◽  
The University

ObjectivesThe ultimate goal of biomedical research is the development of new treatment options for patients. Animal models are used if questions cannot be addressed otherwise. Currently, it is widely believed that a large fraction of performed studies are never published, but there are no data that directly address this question.MethodsWe have tracked a selection of animal study protocols approved in the University Medical Center Utrecht in the Netherlands, to assess whether these have led to a publication with a follow-up period of 7 years.ResultsWe found that 60% of all animal study protocols led to at least one publication (full text or abstract). A total of 5590 animals were used in these studies, of which 26% was reported in the resulting publications.ConclusionsThe data presented here underline the need for preclinical preregistration, in view of the risk of reporting and publication bias in preclinical research. We plea that all animal study protocols should be prospectively registered on an online, accessible platform to increase transparency and data sharing. To facilitate this, we have developed a platform dedicated to animal study protocol registration: www.preclinicaltrials.eu.

Regeneration of facial nerve after hypoglossal facial anastomosis: An animal study

1994 ◽  
Vol 111 (6) ◽  
pp. 710-716 ◽  
Author(s):  
Y CHEN ◽  
N YANAGIHARA ◽  
S MURAKAMI
Keyword(s):  
Facial Nerve ◽  
Animal Study

Second-phase validation of developmental toxicity test using embryoid body's area

2019 ◽  
Author(s):  
Jae-Hwan Lee ◽  
Seon Mi Park ◽  
Eui-Man Jung ◽  
Eui-Bae Jeung
Keyword(s):  
Toxicity Test ◽  
Developmental Toxicity ◽  
Second Phase

Developmental Toxicity Potential of Hydroxyuera, a Positive Control, in Rabbits

1988 ◽  
Author(s):  
Valerie G. Coppes ◽  
Charlotte L. Speckman ◽  
Jr Korte ◽  
Don W.
Keyword(s):  
Developmental Toxicity ◽  
Positive Control ◽  
Toxicity Potential

scholarly journals Comprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032864
Author(s):  
Geraldine Rauch ◽  
Lorena Hafermann ◽  
Ulrich Mansmann ◽  
Iris Pigeot
Keyword(s):  
Medical Ethics ◽  
Missing Values ◽  
Sample Size Calculation ◽  
Ethics Committees ◽  
Secondary Outcome ◽  
Study Protocols ◽  
Individual Assessment ◽  
Statistical Problems ◽  
Multiple Comparison Procedures

ObjectivesTo assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.DesignWe conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees during the past 3 years.SettingThe study population was identified by a comprehensive web search on websites of German medical ethics committees.ParticipantsThe final list comprised 86 eligible persons. In total, 57 (66%) completed the survey.QuestionnaireThe first item checked whether the inclusion criterion was met. The last item assessed satisfaction with the survey. Four items aimed to characterise the medical ethics committee in terms of type and location, one item asked for the urgency of biostatistical training addressed to the medical investigators. The main 2×12 items reported an individual assessment of the quality of biostatistical aspects in the submitted study protocols, while distinguishing studies according to the German Medicines Act (AMG)/German Act on Medical Devices (MPG) and studies non-regulated by these laws.Primary and secondary outcome measuresThe individual assessment of the quality of biostatistical aspects corresponds to the primary objective. Thus, participants were asked to complete the sentence ‘In x% of the submitted study protocols, the following problem occurs’, where 12 different statistical problems were formulated. All other items assess secondary endpoints.ResultsFor all biostatistical aspects, 45 of 49 (91.8%) participants judged the quality of AMG/MPG study protocols much better than that of ‘non-regulated’ studies. The latter are in median affected 20%–60% more often by statistical problems. The highest need for training was reported for sample size calculation, missing values and multiple comparison procedures.ConclusionsBiostatisticians being active in German medical ethics committees classify the biostatistical quality of study protocols as low for ‘non-regulated’ studies, whereas quality is much better for AMG/MPG studies.

Sign in / Sign up

Export Citation Format

Share Document