Lipitor

By T. Konrad. Centre College, Danville Kentucky.

In addition generic 10 mg lipitor with mastercard, information on susceptible positive relationship has been observed between individuals discount lipitor 5mg, populations and life-stages is sum- the exposure and cancer in studies in which marized. Tis section also reports on other toxic chance, bias and confounding could be ruled efects, including reproductive and developmen- out with reasonable confdence. A statement that tal efects, as well as additional relevant data that there is sufcient evidence is followed by a sepa- are considered to be important. Evaluation and rationale target organ or tissue does not preclude the pos- Evaluations of the strength of the evidence for sibility that the agent may cause cancer at other carcinogenicity arising from human and experi- sites. Te strength of the mechanistic evidence A positive association has been observed is also characterized. A classifcation may change as new Tere are several adequate studies covering the information becomes available. When the agents eval- exposure to the agent and any studied cancer uated are considered by the Working Group to be at any observed level of exposure. Te results sufciently closely related, they may be grouped from these studies alone or combined should together for the purpose of a single evaluation of have narrow confdence intervals with an upper the degree of evidence. Bias and confounding should be ruled (a) Carcinogenicity in humans out with reasonable confdence, and the studies should have an adequate length of follow-up. A Te evidence relevant to carcinogenicity from conclusion of evidence suggesting lack of carcino- studies in humans is classifed into one of the fol- genicity is inevitably limited to the cancer sites, lowing categories: conditions and levels of exposure, and length of Sufcient evidence of carcinogenicity: observation covered by the available studies. In Te studies cannot be interpreted as showing the absence of data from conventional long-term either the presence or absence of a carcinogenic bioassays or from assays with neoplasia as the efect because of major qualitative or quantitative end-point, consistently positive results in several limitations, or no data on cancer in experimental models that address several stages in the multi- animals are available. An increased incidence of tumours in data on preneoplastic lesions, tumour pathol- both sexes of a single species in a well conducted ogy, genetic and related efects, structure–activ- study, ideally conducted under Good Laboratory ity relationships, metabolism and toxicokinetics, Practices, can also provide sufcient evidence. Te strength of the evidence that any carcino- For complex exposures, including occupa- genic efect observed is due to a particular mech- tional and industrial exposures, the chemical anism is evaluated, using terms such as ‘weak’, composition and the potential contribution of ‘moderate’ or ‘strong’. Te Working Group then carcinogens known to be present are considered assesses whether that particular mechanism is by the Working Group in its overall evaluation likely to be operative in humans. Te Working Group indications that a particular mechanism oper- also determines the extent to which the materi- ates in humans derive from data on humans als tested in experimental systems are related to or biological specimens obtained from exposed those to which humans are exposed. Te data may be considered to be espe- cially relevant if they show that the agent in ques- (d) Overall evaluation tion has caused changes in exposed humans that Finally, the body of evidence is considered as are on the causal pathway to carcinogenesis. Strong support can be obtained from stud- for this broader group of agents if the strength of ies that challenge the hypothesized mechanism the evidence warrants it. Te categorization of Working Group considers whether multiple an agent is a matter of scientifc judgement that mechanisms might contribute to tumour devel- refects the strength of the evidence derived from opment, whether diferent mechanisms might studies in humans and in experimental animals operate in diferent dose ranges, whether sepa- and from mechanistic and other relevant data. Te possible contribution of alternative mecha- Tis category is used when there is suf- nisms must be considered before concluding cient evidence of carcinogenicity in humans. It may one extreme, the degree of evidence of carcino- also be used when there is inadequate evidence genicity in humans is almost sufcient, as well as of carcinogenicity in humans but there is suf- those for which, at the other extreme, there are cient evidence of carcinogenicity in experimental no human data but for which there is evidence of animals. Agents there is inadequate evidence of carcinogenicity in are assigned to either Group 2A (probably car- humans and less than sufcient evidence of car- cinogenic to humans) or Group 2B (possibly cinogenicity in experimental animals together carcinogenic to humans) on the basis of epide- with supporting evidence from mechanistic and miological and experimental evidence of carci- other relevant data may be placed in this group. Te terms probably carcinogenic and possi- on the basis of strong evidence from mechanistic bly carcinogenic have no quantitative signifcance and other relevant data. Tis category is used most commonly for Group 2A: The agent is probably agents for which the evidence of carcinogenicity carcinogenic to humans. Tis category is used when there is limited Exceptionally, agents for which the evidence evidence of carcinogenicity in humans and suf- of carcinogenicity is inadequate in humans but cient evidence of carcinogenicity in experimental sufcient in experimental animals may be placed animals. In some cases, an agent may be classi- in this category when there is strong evidence fed in this category when there is inadequate evi- that the mechanism of carcinogenicity in experi- dence of carcinogenicity in humans and sufcient mental animals does not operate in humans. Exceptionally, an agent may be clas- nation of non-carcinogenicity or overall safety. An especially when exposures are widespread or agent may be assigned to this category if it clearly the cancer data are consistent with difering belongs, based on mechanistic considerations, to interpretations. Tis category is used for agents for which there is evidence suggesting lack of carcinogenicity 28 Preamble in humans and in experimental animals. Proceedings of a consensus experimental animals, consistently and strongly conference. Te sci- ence and practice of carcinogen identifcation and (e) Rationale evaluation. A comparison in experimental animals, and mechanistic and of tests for trend with historical controls in carcinogen other relevant data. Use of historical provided, together with their scientifc rationale control data in carcinogenicity studies in rodents.

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