Alternative methods in toxicology: pre-validated and validated methods
نویسندگان
چکیده
The development of alternative methods to animal experimentation has progressed rapidly over the last 20 years. Today, in vitro and in silico methods have an important role in the hazard identification and assessment of toxicology profile of compounds. Advanced alternative methods and their combinations are also used for safety assessment of final products. Several alternative methods, which were scientifically validated and accepted by competent regulatory bodies, can be used for regulatory toxicology purposes, thus reducing or fully replacing living animals in toxicology experimentation. The acceptance of the alternative methods as valuable tools of modern toxicology has been recognized by regulators, including OECD, FDA and EPA.This paper provides a brief overview of the topic "alternative methods in toxicology" and focuses on pre-validated and validated alternative methods and their position in the modern toxicology.
منابع مشابه
JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results.
The in vivo rodent alkaline comet assay (comet assay) is used internationally to investigate the in vivo genotoxic potential of test chemicals. This assay, however, has not previously been formally validated. The Japanese Center for the Validation of Alternative Methods (JaCVAM), with the cooperation of the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NIC...
متن کاملCorrelation of results between validated in-house analysis method with new pharmacopeia monograph for analysis of Sitagliptin Phosphate API
Having validated analysis methods for medicinal ingredients is attractive for pharmaceutical companies. When a new molecule is introduced to the market, there is not any pharmacopeial analysis method for that. After publishing official methods, correlation between validated in-house methods and the official one could stablish the value of the in-house method. Sitagliptin phosphate is a new anti...
متن کاملQuantification of Polyethylene Glycol Esters of Methotrexate and Determination of Their Partition Coefficients by Validated HPLC Methods
Conjugation of methotrexate (MTX) (MW 454) with different molecular weights of polyethylene glycol (PEG) including methoxy-peg (mpeg) 750 D and 5000 D and diol-peg 35000 D led to compounds that are physicochemically highly different from the parent compound, MTX. In this study, an HPLC system consisting of C8 column and UV detector (?=342 nm), using a mixture of 30:70 v/v phosphate-citrate buff...
متن کاملValidated UV-Vis Spectrophotometric Method for Determination of Gabapentin using Acetyl Acetone and Formaldehyde Reagents
Gabapentin is an anticonvulsant widely used in the treatment of epilepsy.An accurate and validated spectrophotometric method was developed as an alternative method to determine gabapentin in pharmaceutical products. This is a simple, accurate, precise, selective and visible spectrophotometric method. The method is based on the measurement of drug absorbance as a result of yellow solution format...
متن کاملReport of an ISRTP workshop: progress and barriers to incorporating alternative toxicological methods in the U.S.
The workshop objectives were to explore progress in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs in the United States, to identify barriers and to develop recommendations to further promote adoption of approaches that reduce, refine, or replace the use of animal methods. The workshop included sessions o...
متن کامل