In Vitro Sample Clauses

In Vitro. Assays The optimization, validation, and data analysis of in vitro assays must be performed in a manner that follows scientific and statistical principles, including Design and Optimization, Validation, Analysis, and Analysis Comparison and Correlation.
Sample 1
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In Vitro. In vitro tooth wear models are carried out in the laboratory with no patient contact or involvement. They can involve techniques that solely mimic the earliest stages of erosive demineralisation (in which surface changes including softening occur without loss of bulk tissue) and techniques which involve bulk tissue loss (in which acids initiate surface softening followed by a mechanical process which removes the vulnerably softened tissue). The later model aims to mimic the clinical situation where the outcome is loss of enamel and dentine usually due to a multifactorial tooth wear process. In order to further simulate a process of alternate demineralisation and remineralisation a cyclic design may be employed to simulate tooth wear causing tissue loss. Most work in the field of tooth wear research has taken place in vitro and the advantages of this approach to modelling of tooth wear include the following: • achievability of a high degree of standardisation; • ability to control numerous variables (including acidic challenge and concentration, substrate type and nature); • inclusion of large sample sizes and use of control groups; • results can be obtained relatively rapidly with minimal expenditure in comparison with in vivo and in situ tooth wear research. Extrapolating the results of in vitro studies to the clinical tooth wear is problematical, in part due to the inability to replicate the complexity of the oral environment in the laboratory but also due to by the heterogeneity of the applied methodologies used in the laboratory. Therefore only potential trends may be suggested by early erosion models and tissue loss models (Xxxxxxxxxx et al., 2006). Review of the literature of all in vitro tooth wear research reveals some of the wide variation in methods employed for the following parameters: • type of tooth wear simulated (erosion; attrition; abrasion) • substrate (human enamel/dentine; bovine enamel/dentine; hydroxyapatite) • sample preparation (polished, virgin tooth surface) • study design (single/cyclic/alternating order of challenge and remineralisation periods, timing and number of cycles) • Erosive agent (chemistry/pH/immersion time/flow rate/temperature/volume- substrate ratio) • Tooth brush abrasion wear simulation, (tooth brush machine, brush design, brushing behaviour, toothpaste) • Attritional wear (two or three body wear behaviour, wear machine, , type of antagonist, antagonist geometry, frequency of change of antagonist, total number of...
Sample 1

Related to In Vitro

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  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

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  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Trials The Ship shall run the following test and trials:

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