General safety tests

General Safety According the Food and Drug Administration (FDA), cellular therapy products are exempt from general safety testing [21 CFR 610.11(g)(1)]. 

Sampling ndAnalysis Guidelines. As a general safety consideration, ah gases should be vented to an external area and whenever possible, inert gases should be used as the test gas for piping systems. 

The National Safety Council, National Fire Protection Association, and other similar organizations pubHsh technical information that describes general safety practices for use during the testing, handling, storage, and transport of sulfur (21,36—40). Each of these pubHcations include a Hst of references for additional health and safety information. 

Standardization and Testing". RequHemeats are geaerally specified within Hceases Hi the United States, and include a variety of Hi-process tests to assess purity, safety, and potency of the iadividual components and potency and safety of the final product. Potency is standardized by determining the size of the conjugate and the quantitative amount of saccharide that is bound to the carrier protein. General safety and immunogenicity is assessed Hi animals. 

Shunt power capacitors of non self-healing types up to and including 1000 V General performance, testing and rating. Safety requirements. Guide for installation and operation 13585-1/1994 BS EN 60931-1/1996... 

Initial safety tests were carried out in beagle dogs and subsequently in cynomolgus monkeys. Single bolus i.v. doses of up to 100 mg kg-1 were used and were found to exert no negative effect upon general condition, blood pressure, heart or cardiovascular parameters, respiration rate or body temperature. No safety tests evaluating potential product effects upon the central nervous system were undertaken, as the protein is considered unlikely to cross the blood-brain barrier. 

POLYMERS AND BIOLOGICAL SAFETY TESTING GENERAL AND SPECIFIC RISK ASSESSMENT Baldrick P... 

By the time Phase III testing is completed, some additional preclinical safety tests must also generally be in hand. These include the three separate reproductive and developmental toxicity studies (Segments I and III in the rat, and Segment II in the rat and rabbit) and carcinogenicity studies in both rats and mice (unless the period of therapeutic usage is intended to be very short). Some assessment of genetic toxicity will also be expected. 

Oral contraceptives are subject to special testing requirements. These have recently been modified so that in addition to those preclinical safety tests generally required, the following are also required (Berliner, 1974) ... 

To secure adequate pharmacological and safety testing and clinical trials of new drugs before their release for general use. 

The types of scientific tests needed to estabhsh safety are dependent on the nature of the regulated product and its proposed use. A product such as a food or color additive will require tests to elucidate the potential of the product to induce adverse acute, subchronic, and chronic effects. The safety tests are generally performed in animals and other biological systems. Both the t5rpes of tests and the methodology of particular tests have changed over the years with scientific advances in the field of toxicology. 

Test safety device (automatic shutdown and general safety equipment) for proper operation. 

In general, safety evaluation is primarily based on the toxicological testing of the parent drug. However, consumers of edible animal products are also exposed to many other products of drug metabolism, including free metabolites of... 

Safety Test, It was to determine whether the bomb can be dropped safely, that is without detonation on impact. It was concerned with the sensitivity, strength, and general design of the fuze, the sensitivity and suitability of the bomb filler, and the structural strength of the bomb assembly... 

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