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(223Ra) dichloride
(223Ra) dichloride

... the traditional role of chemotherapy in metastatic CRPC had been for palliative care without any survival benefit. Since the finding that docetaxel in combination with prednisone improved survival in studies compared to mitoxantrone plus prednisone, docetaxel has been considered standard first line ...
Management of Oral Anticoagulant Therapy
Management of Oral Anticoagulant Therapy

... oral vitamin K, 2.5–5 mg Oral vitamin K, 2.5–5 mg * Allow 2 days after dosage change for clotting factor equilibration. Repeat prothrombin time 2 days after increasing or decreasing warfarin dosage and use new guide to management (INR = International Normalized Ratio). After increase or decrease of ...
Biologic agents in psoriasis
Biologic agents in psoriasis

... the study, a significantly (P < 0.001) higher percentage of patients in the 15 mg group (33%) or 10 mg group (28%) than in the placebo group (13%) achieved at least 75% PASI reduction from baseline. The percentage of patients achieving at least 50% reduction in PASI throughout the study period was 5 ...
current problems - UK Government Web Archive
current problems - UK Government Web Archive

... of this enzyme (such as ‘azole’ anti-fungal agents or HIV protease inhibitors) may particularly increase plasma levels of these drugs and so increase the risk of dose-related side effects, including rhabdomyolysis. The risk of serious myopathy is also increased when high doses of simvastatin are com ...
A Human Vascular Model Based on Vasoconstrictive Dose-Response Effects of
A Human Vascular Model Based on Vasoconstrictive Dose-Response Effects of

... Much of our knowledge about the effects of drugs on microvascular function stems from dose response studies on isolated vessels and from intravital microscopic studies. These models have been of paramount importance in the development of new vasoactive drugs. An important shortcoming of in vitro mod ...
Product Monograph - AstraZeneca Canada
Product Monograph - AstraZeneca Canada

... Safety data from the following studies were integrated for the evaluation of safety: a randomised, double-blind, parallel-group, multicentre, Phase III study (CONFIRM), a randomised, open-label, multicentre, Phase II study (NEWEST), and 2 randomised, doubleblind, parallel-group, multicentre, Phase I ...
Prescribing Information
Prescribing Information

... Renin-angiotensin system (RAS) inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy), or who have compromised renal function, coadministration of NSAIDs, including DURLAZA, with RAS inhibitors may result in deterioration of renal function, including possible ...
KIPRES® Chewable Tablets 5mg
KIPRES® Chewable Tablets 5mg

... sheet are used, patients should be instructed to take the drugs out of the sheet. [It has been reported that when patients mis-swallowed drugs with a PTP sheet (after failing to take the drugs out of the sheet), a hard, sharply angled edge of the sheet struck to the esophageal mucosa. Furthermore, i ...
Delayed and Omitted Doses of Medicines
Delayed and Omitted Doses of Medicines

... 5.4. Reporting Delayed or Omitted doses as Patient Safety Incidents (via Datix) N.B. Items 2 and 10 have specific Datix reporting prompts ...
Advancing Safety Science and Health Research with Innovative
Advancing Safety Science and Health Research with Innovative

... Some 300 million people currently suffer from asthma, yet only two types of treatment have become available in the last 50 years. More than a thousand potential drugs for stroke have been tested in animals, but only one of these has proved effective in patients. And it’s the same story with many oth ...
Waiver of In Vivo Bioavailability and Bioequivalence
Waiver of In Vivo Bioavailability and Bioequivalence

... rapid in relation to gastric emptying and the drug has high permeability, the rate and extent of drug absorption is unlikely to be dependent on drug dissolution and/or gastrointestinal transit time. • Under such circumstances, demonstration of in vivo BA or BE may not be necessary for drug products ...
Australian public assessment for radium (223Ra) dichloride
Australian public assessment for radium (223Ra) dichloride

... the traditional role of chemotherapy in metastatic CRPC had been for palliative care without any survival benefit. Since the finding that docetaxel in combination with prednisone improved survival in studies compared to mitoxantrone plus prednisone, docetaxel has been considered standard first line ...
metabolism, disposition, excretion, and pharmacokinetics of
metabolism, disposition, excretion, and pharmacokinetics of

... minimum dose levels where bone efficacy was observed. Blood Sampling and Drug Analysis for Pharmacokinetic Experiments. Blood samples were collected before, 4, 6, 24, and 48 h after the sixth administration (day 13), and before, 4, 6, 24, 48, 54, 72, and 96 h after the final administration (day 34). ...
Intravenous Agents - RAH
Intravenous Agents - RAH

... action subsequent demethylation may occur resulting in a longer acting metabolite these compound have a high incidence of excitatory phenomena pentobarbital, secobarbital, thiopental, thiamylal and methohexital all posses asymmetrical carbon atoms in their side chains the l-isomers are ~ 2x as poten ...
INTERNATIONAL RARE DISEASE RESEARCH CONSORTIUM
INTERNATIONAL RARE DISEASE RESEARCH CONSORTIUM

... additional regulatory and funding obstacles. For severe rare diseases, travel to research centres may be impossible. Some solutions propose monitoring patients remotely, setting up community centres to include patients in trials who would otherwise be unable to access them.12 Effective recruitment i ...
Product Monograph - Novo Nordisk Canada
Product Monograph - Novo Nordisk Canada

... In clinical trials of VICTOZA®, subjects with clinically significant heart disease, acute myocardial infarction within 6 months, unstable angina pectoris and congestive heart failure (NYHA, class III to IV) were not studied. Therefore, VICTOZA® should be used with caution in ...
FORMULATION AND EVALUATION OF PULSATILE TABLET IN CAPSULE DEVICE Research Article
FORMULATION AND EVALUATION OF PULSATILE TABLET IN CAPSULE DEVICE Research Article

... Development of suitable chronotherapeutic oral dosage forms can be achieved using delayed and/or pulsatile technologies. A pulsatile release is characterized by proportioning drug concentration throughout 24-hour period (circadian rhythm) in synchrony with biological rhythm determinants of disease h ...
Cyclodextrins as Sustained
Cyclodextrins as Sustained

... the treatment of endocrine-dependent metastatic prostate carcinoma. Because of its short biological half-life, frequent injections and nasal applications of the drug must be administered so that its therapeutic concentration is maintained (16). The solid complex of buserelin acetate with DE--CD in ...
  FORMULATION AND IN VITRO EVALUATION OF SUSTAINED RELEASE FLOATING TABLET OF  CEPHALEXIN USING HYDROPHILIC POLYMERS 
  FORMULATION AND IN VITRO EVALUATION OF SUSTAINED RELEASE FLOATING TABLET OF  CEPHALEXIN USING HYDROPHILIC POLYMERS 

... flexibility in formulation etc. From immediate release to site specific  delivery, oral dosage forms have really progressed. A gastric floating  drug  delivery  system  (GFDDS)  1,2,3  can  overcome  at  least  some  of  these problems and is particularly useful for drugs that are primarily  absorbe ...
Clinical Pharmacokinetics Of
Clinical Pharmacokinetics Of

... of therapy yield relatively little information about the eventual steady-state concentrations. For this reason, routine plasma Phenobarbital concentrations should be monitored two to three weeks after the initiation or a change in the Phenobarbital regimen. Plasma samples obtained before this time s ...
Tricyclic Antidepressants
Tricyclic Antidepressants

... TCAs have numerous clinically significant drug interactions. Some of these involve additive effects when co-prescribed with ...
ENHANCEMENT OF ANTI-KLH IgG ANTIBODY PRODUCTION IN
ENHANCEMENT OF ANTI-KLH IgG ANTIBODY PRODUCTION IN

... ranged between 0.098 and 0.113 g/cm3 (average 0.105 g/cm3). Experimental animals: 20 male New Zealand white rabbits (bred in the animal facilities of the Trakia University) were used in the study. They were in good health, 5-month-old and weighed between 3.5 and 4.0 kg at the beginning of the experi ...
full Prescribing Information
full Prescribing Information

... agents, including antipsychotics, or drugs that impair metabolism of serotonin, including MAOIs, has not been systematically evaluated and has not been established. If concomitant administration of BELVIQ/BELVIQ XR with an agent that affects the serotonergic neurotransmitter system is clinically war ...
Correlating In Vitro Data to In Vivo Findings for Risk
Correlating In Vitro Data to In Vivo Findings for Risk

... collaboration, which means our NIH consortium involves both US EPA’s ToxCast and the Hamner Institutes, the other major players implementing the Tox-21c vision. The Pathways of Toxicity Mapping Center (PoToMaC) at Johns Hopkins University is a vision for an institutionalized effort towards producing ...
In This Issue: Journal of the Scleroderma Clinical Trials Consortium
In This Issue: Journal of the Scleroderma Clinical Trials Consortium

... heterogeneous nature of disease expression and too often patients had late disease with established fibrosis that would not necessarily be amenable to the treatments tried. A multicenter Phase II clinical trial comparing oral Type I bovine collagen as a toleragen to placebo evaluating effect on the ...
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