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. 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 implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the preclinical efficacy and safety data for our bb2121 product candidate will not be observed in the CRB-401 clinical study, the risk of cessation or delay of any of t...
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. 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. 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. The usual starting dose is 10mg dexamfetamine sulphate a day, given in divided doses. Dosage may be increased if necessary by 10mg a day at weekly intervals to a suggested maximum of 60mg a day.
Dose. Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
Dose. The amount of ionizing radiation energy received. See also absorbed dose, equivalent dose, and effective dose.
Dose. .6 Lamp power output.
