Dose. The second portion of the study is a dose expansion phase where patients will receive bb2121 to further evaluate the safety, tolerability and clinical activity at the recommended Phase 2 dose. About bluebird bio, Inc. With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D™ product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin® BB305 product candidate, currently in three clinical studies for the treatment of transfusion-dependent ß-thalassemia, also known as ß-thalassemia major, and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio also has discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline. bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington, and Paris, France. LentiGlobin and Lenti-D are trademarks of bluebird bio, Inc. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical and market potential of the Company’s anti-BCMA oncology program, including its bb2121 product candidate. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B...
Dose. Most agents are available in 0.5 M concentration. A single dose is typically 0.1 mmol/kg body mass leading to 10–20 ml injec- tion volume. Once the contrast agent and dose are set, they Recommendations for quality assurance A QA process should be in place using phantoms. This should be based on the study requirements and should demonstrate: • That the effects of regional variations in B1 homogeneity are small compared with the minimum change to be measured in patients • That the effects of any automated image enhancement processes do not affect quantification • That flip angles are calibrated correctly and the T1-weighted signal is stable over the acquisition period • Equivalence for different field strengths (if used) Contrast agents (dose, delivery, compounds, safety) Introduction Many low molecular weight (LMW) gadolinium-based con- trast agents have been approved for use in humans [36]. DCE-MRI use is technically “off-label” but similar in dose and delivery rate to clinical protocols. Some gadolinium- based contrast agents have significant liver uptake or protein binding that would need special protocols if used. It is unclear whether ionic and non-ionic agents produce differ- ent values of DCE-MRI parameters. Iron- and manganese- based agents are not recommended for DCE-MRI.
Dose in its sole discretion and at its own expense, shall control the entire patent process relating to the Dose Licensed Patents and the Glaukos Group 2 Licensed Patents, including without limitation, prosecution of patent applications and maintenance, reexamination, reissue, and extension of patents; provided, however, that DOSE agrees to (i) promptly provide copies of all prosecution documents to GLAUKOS upon request; (ii) provide GLAUKOS an opportunity to contribute to the prosecution of claims relating to the Glaukos Field of Use, including without limitation making suggestions for (A) claims to pursue, (B) claim amendments and (C) responsive arguments, and consider in good faith whether to adopt any such suggestions and contributions in any responsive filing to a patent office; (iii) subject to clause (iv) below, maintain all issued patents and pending patent applications licensed to GLAUKOS, including paying any and all maintenance fees and annuities; and (iv) notify GLAUKOS in writing sixty (60) days prior to the abandonment of any patent or application for a patent licensed to GLAUKOS, and if requested by GLAUKOS, assign such patent or application to GLAUKOS to take action to prevent the abandonment thereof. Any patent or patent application assigned pursuant to this Section 7.3 shall hereby be licensed back to the DOSE on a non-exclusive, worldwide, irrevocable, perpetual, fully paid-up basis, without the right to sublicense, to make, have made, use, import, offer for sale, sell and otherwise develop and commercialize any and all products and to practice any and all methods that fall within the scope of such patent or patent application outside of the Glaukos Field of Use. With respect to the Glaukos Group 2 Licensed Patents, GLAUKOS will, among other things, assist DOSE in exercising its rights hereunder to control the entire patent process related to the Glaukos Group 2 Patents, and GLAUKOS hereby irrevocably designates and appoints DOSE as its agent and attorneys-in-fact, coupled with an interest, to act for and on GLAUKOS’ behalf to execute and file any document and to do all other lawfully permitted acts to further the foregoing provisions of this Section 7.3 with the same legal force and effect as if executed by GLAUKOS.
Dose. The amount of ionizing radiation energy received. See also absorbed dose, equivalent dose, and effective dose.
Dose. A community survey conducted at the last 2012 market showed 37% attended the market once during the season, 47% attended 2D5 times, and 16% attended every market. Results were slightly different for an online survey administered postDmarket season. Figure 15 shows results; with 43% attending the market 1D2 times, 44% 3D5 times and 3% attended all markets. Although grant funding only allowed for a monthly market, the community attendees and vendors strongly supported the idea of a weekly market. The monthly market made it difficult to promote, since new advertisements had to go out every month to remind the public of the market. Also, farmers do not generally harvest once a month during the summer and expressed the need for a steady weekly market to provide income. However, the monthly market was a good dose for smaller scale growers who did not have enough food to sell weekly, but were still able to sell some produce or crafts every month for income. Figures 16 through 19 describe the dose received in the farmers market program in terms of number of produce vendors, money spent by market attendees, vendor revenue and SNAP benefits spent at the market. From May to October there were 26 different produce, prepared foods and craft vendors at the market. On average, there were 10 food vendors at each market. Figure 16 shows changes in food vendors over the season. From June to October, all vendors made a total of $12,681. Figure 17 shows changes in vendor incomes over time, with the peaks in revenue being at the beginning and ending of the season. The average revenue for a market was $2,536. Average dollars spent per attendee to the market drastically increased by over $2 for the last market. Figure 18 shows a graph of the changes over the season, with $7.11 being the overall average amount spent at the market. SNAP dollars spent at the market also increased drastically at the last market, moving from $54 at the September market to $444 after doubling at the October market. The proportion of total market income due to SNAP dollars is portrayed in Figure 19. Over $1,000 SNAP dollars were spent during the entire season, with an average of $180 per market. This change reflected a marketing strategy that was implemented for the final market and aimed to raise awareness among lowDincome and international populations of Clarkston.
Dose. In view of the active functionalisation and the possible interaction of nanoparticles with bio- molecular structures, it is important to consider the dose and dose rate of the MNM, its ability to spread within the body, the decay of number concentration and the erosion of individual particles. Many nanoparticles will have considerable solubility. For these materials the interaction with living systems remains close enough to the bulk chemical agent to justify the use of well-established toxicological testing procedures and approaches. For biodegradable particles, the particle composition and degradation products will influence their biological effects. On the other hand, materials with very low solubility or degradability, could accumulate within biological systems and persist there for long durations. It is with nanoparticles of this character that the greatest concerns must arise, and attention will have to be paid to the comparison of the persistence of the particles and the time constants of the metabolic and cellular activities within the target host. The dose and frequency determine the influx rate in the body or organ/tissue, which will give direction whether accumulation can be expected.
Dose. .6 Lamp power output.
Dose. Administration Acamprosate is available as 333mg enteric-coated tablets (Campral EC). Oral administration. Taking Acamprosate with food may reduce its bioavailability but reduce side-effects. Treatment should be initiated as soon as possible after detoxification and can be started during a chlordiazepoxide detoxification. There is some evidence to suggest that starting it before the detoxification may reduce the risk of kindling and worsening subsequent withdrawals. It should be prescribed in combination with adjunctive psychosocial interventions. Treatment can be continued for up to 12 months but in practice this is usually 3-6 months. Acamprosate should be stopped in the event of a full relapse, lack of efficacy or intolerable side-effects. It works best in those who are abstinent but may be effective in reducing the risk of a minor lapse becoming a full relapse (return to heavy drinking for 4-6 weeks) so it should be continued in these patients until a full relapse becomes obvious. Adult >60kg: 666mg (2 tablets) three times a day Adult <60kg:666mg mane, 333mg midday and 333mg 6pm Please note that in all cases the specialist service will prescribe the first 2-4 weeks prior to asking the GP to continue prescribing.
Dose. A ratio of noise exposure relative to the noise criterion level of 90 decibels, expressed as a percentage. Ninety decibels represents a dose of 100% over an 8-hour work shift. Eighty-five decibels represents a dose of 50% over an 8-hour work shift. Dose is based on the OSHA 5 dB exchange rate. Dose may be determined from the equation given in Table 1 for non- continuous noise or estimated from Table 2 based on the TWA.
