| 1. | Merck Frosst Canada - Clinical Research Overview |
| | With the approval of the TPP, medicines found to be safe and effective in animals are tested first in healthy volunteers, then in patients with the target disease, and then in the large-scale clinical trials that are the hallmark of pharmaceutical research.... Clinical trial participants are recruited by physicians, usually through their practices, by patient chart reviews and by advertising.... |
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| 2. | Merck Frosst Canada - Respiratory Diseases |
| | Allergic rhinitis (hay fever and house-dust allergies) is also an area of current interest ; not least because clinical trials of SINGULAIR® have provided evidence for its effectiveness in this condition.... |
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| 3. | Merck Frosst Canada - Pharmacology |
| | This information is critical to the selection of safe doses that can be studied in human clinical trials.... For the development of SINGULAIR®, our pharmacologists were able to provide essential structure / activity data, and build the crucial bridge between theoretical chemistry, and clinical trials in humans.... |
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| 4. | Merck Frosst Canada - Preparative (Process) Chemistry |
| | Material produced in the preparative laboratories will be used by other Merck departments to conduct safety testing and early clinical trials.... |
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| 5. | Merck Frosst Canada - Clinical Supplies |
| | The Clinical Supplies department at the Merck Frosst Centre for Therapeutic Research prepares experimental dosage forms of all new drug candidates discovered in the Research Centre, to support clinical trials of the drug in humans.... The packaging operation can be viewed as the first crucial step in the clinical trials of a potential drug : supplies must be correctly packaged according to the protocol of each study, generally in a blinded fashion, before being shipped to their destination.... |
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| 6. | Merck Frosst Canada - Formulation and Process Development |
| | Based on the results of the model formulation study, the scientists prepare more refined formulations, suitable for use in clinical trials.... As the clinical trials progress, the researchers refine, optimize, and, finally, scale up laboratory-scale formulations and processes to commercial production scale.... |
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| 7. | Merck Frosst Canada - Data Management |
| | The second step is to put in place a system of checks and balances to ensure that no inconsistencies are unresolved.Merck Frosst regionally based data monitors travel to every clinical trial site and check that the data are documented appropriately and supported by the official source documents.. Merck Frosst conducts a targeted verification of clinical trial data - data points are checked against a source document such as patient records or workbooks.. |
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| 8. | Merck Frosst Canada - Clinical Research |
| | The Clinical Research Division plans and executes clinical trials from phase I to phase IV according to the highest scientific and ethical standards.... |
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| 9. | Merck Frosst Canada - Section Reserved For Media |
| | In a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with SINGULAIR, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received SINGULAIR.... |
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| 10. | Merck Frosst Canada - Vaccine-Preventable Diseases |
| | In clinical trials, the most frequently reported local side effects were pain, redness and swelling which were normally mild and resolved within 24 to 72 hours following vaccination.... |
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