Toxicology regulatory aspects

Prival, M. J., Genetic toxicology regulatory aspects. J. Environ. Path. Toxicol. 3 99-111 (1980). 

Methylnaphthalene in Food Packaging and Cadmium in Food Packaging and Household Items Overview of Exposure, Toxicology, Regulatory Aspects, and Research Needs... 

E. Regulatory Toxicology These aspects, concerned with the formulation of laws, and regulations authorized by laws, are intended to minimize the effect of toxic chemicals on human health and the environment. 

A recent book edited by Dixon (ref. 10) addresses reproductive toxicology mostly from the physiological point of view. However, several chemically oriented chapters are of interest—such as those on reproductive effects of chemical agents, assessing risk of reproductive dysfunction associated with chemical exposure, and regulatory aspects of reproductive toxicity. 

Medical, environmental, and regulatory aspects of Cr toxicology have been described in detail in several books (1, 2, 7, 107-110) and recent reviews (9, 11,... 

Flavors constitute perhaps the largest technically functional group of substances and additives used in food. Flavors really cannot be separated from food. This paper will discuss the regulatory toxicology aspects of food safety, with emphasis on the use of flavors in food, and in particular with the recent innovations of flavor product development. 

Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives. 

Any detailed examination on intrauterine development, sex differentiation, and pubertal development is beyond the scope of this discussion. Highly specialised methods need to be applied, and there is usually no indication for such effects from the early regulatory toxicology studies (28 days in rats and dogs). The special aspects of toxicological findings with xenobiotics have been reviewed for the female reproductive tract... 

In summary, FDA combines the regulatory, chemistry, toxicology, and environmental information on a new FCS or new use of an FCS for its premarket safety assessment for the intended conditions of use. Pivotal aspects of the chemistry, toxicology, and environmental reviews are elaborated upon in the next three sections. 

In light of these developments, we felt that it was necessary to review the content of the first edition and to update or supplement the information presented in this work. The new topics examined in this edition include (1) enzymatic synthesis and resolution of enantiomerically pure compounds (Chapter 8) (2) toxicological consequences and implications of stereoselective biotransformations (Chapter 9) (3) stereoselective transport across epithelia (Chapter 10) and (4) assessment of bioavailability and bioequivalence of stereoisomeric drugs (Chapter 11). The chapter on stereoselective protein binding (Chapter 12) has been completely revmtten and new contributions are presented on the regulatory, industrial, and clinical aspects of stereoisomeric drugs (Chapters 13-16). In addition, the chapters... 

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