The Research Pharmacy provides a mechanism to develop, procure and validate the preparation and packaging of investigational drugs for clinical use.
Aims i nclude: - Development and validation of stability indicating assays - Verifying the accuracy of compounded medications - Determine the extended stability to improve medication shelf life - Validated packaging of medications where MSKCC holds the IND. Services include, but are not limited to, formulation analysis, selection of excipients, evaluation of release rates, prediction of interactions and determination of compatibility and stability of medications used in clinical practice. Specific equipment is available to package medications in capsules which is ideal for placebo controlled trials, as well as a Class 10,000 cleanroom for aseptic packaging of sterile injectables (vaccines, antibodies, small molecule injectables and opthalmics). The cleanroom is also helpful in reducing contamination in packaging of oral products which are prone to microbial growth - such as sugarbased formulations. This facility approaches cGMP standards and is fully compliant with the stipulations of USP 29 specifically chapters 795, 797, 1163 and 1075. All processes are thoroughly validated in accordance with all compendial standards. This facility also makes ample use of High Performance Liquid chromatography (HPLC) and is equipped with a Photodiode array for both UV and visible light and a fluorescence detector. This device has been used to validate the accuracy of all medications compounded within the facility. The fluorescence detector is useful to tract minute elutions from depot injection. The HPLC device has been used to determine extended stability of FDA approved drugs in clinical use here at MSKCC.
|Orlow, I; Satagopan, J M; Berwick, M et al. (2015) Genetic factors associated with naevus count and dermoscopic patterns: preliminary results from the Study of Nevi in Children (SONIC). Br J Dermatol 172:1081-9|
|Carey, Bryce W; Finley, Lydia W S; Cross, Justin R et al. (2015) Intracellular ?-ketoglutarate maintains the pluripotency of embryonic stem cells. Nature 518:413-6|
|Mosher, C E; Given, B A; Ostroff, J S (2015) Barriers to mental health service use among distressed family caregivers of lung cancer patients. Eur J Cancer Care (Engl) 24:50-9|
|Navi, Babak B; Reiner, Anne S; Kamel, Hooman et al. (2015) Association between incident cancer and subsequent stroke. Ann Neurol 77:291-300|
|Xu, Zhe; Wu, Chaochao; Xie, Fang et al. (2015) Comprehensive quantitative analysis of ovarian and breast cancer tumor peptidomes. J Proteome Res 14:422-33|
|Xu, Hong; Cheng, Ming; Guo, Hongfen et al. (2015) Retargeting T cells to GD2 pentasaccharide on human tumors using Bispecific humanized antibody. Cancer Immunol Res 3:266-77|
|Gondo, Tatsuo; Poon, Bing Ying; Matsumoto, Kazuhiro et al. (2015) Clinical role of pathological downgrading after radical prostatectomy in patients with biopsy confirmed Gleason score 3 + 4 prostate cancer. BJU Int 115:81-6|
|Das, Sudeep; Thorek, Daniel L J; Grimm, Jan (2014) Cerenkov imaging. Adv Cancer Res 124:213-34|
|Fay, Allison; Glickman, Michael S (2014) An essential nonredundant role for mycobacterial DnaK in native protein folding. PLoS Genet 10:e1004516|
|Ripley, R Taylor; McMillan, Robert R; Sima, Camelia S et al. (2014) Second primary lung cancers: smokers versus nonsmokers after resection of stage I lung adenocarcinoma. Ann Thorac Surg 98:968-74|
Showing the most recent 10 out of 836 publications