| 1. | Merck Frosst Canada - Process Chemistry Overview |
| | Once development of the process is completed at bench scale (grams), it is scaled up in our preparative laboratory facilities to produce between 1 and 5 kg of bulk drug for use in safety and clinical studies.... |
| |
| 2. | Merck Frosst Canada - Pharmaceutical R&D Overview |
| | Consignments of experimental formulations of the potential drug are shipped to the clinical trial centres directly from our new, state-of-the-art Clinical Supplies centre that was constructed in 1992. It represents a major expansion in our ability to support the global clinical studies of Merck & Co, Inc This is the area where processes used to make the dosage form are optimized and scaled-up.... |
| |
| 3. | Merck Frosst Canada - Clinical Supplies |
| | The knowledge and experience gained in preparing these experimental dosage forms is part of the technology transfer that takes place from research to manufacturing in the run up to the launch of a new drug.Clinical Supplies comprises two functional groups : manufacturing and packaging, which work together to supply clinical studies being conducted worldwide.. |
| |
| 4. | Merck Frosst Canada - Section Reserved For Media |
| | In clinical studies in patients with asthma, adverse events were generally mild and varied by age.... In clinical studies in patients with allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo.... |
| |
| 5. | Merck Frosst Canada - Executive Speeches |
| | Results of these clinical studies are used by regulatory agencies such as the FDA or Health Canada to grant authorization to bring a product to market.... |
| |
| 6. | Merck Frosst Canada - VIOXX® Information Center |
| | The results of clinical studies with one molecule in a given class are not necessarily applicable to others in the class.... |
| |
