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overview of comments received on community - EMA
overview of comments received on community - EMA

... that the vast majority of clinical studies has been conducted not in patients with mild, but with mild to moderate or moderate depression, and that efficacy was comparable with standard antidepressants authorized for the treatment of major depression, including moderate depression, leads to the conc ...
Australian public assessment for Febuxostat (FBX)
Australian public assessment for Febuxostat (FBX)

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Extract from Clinical Evaluation Report: Crizotinib
Extract from Clinical Evaluation Report: Crizotinib

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Use these links to rapidly review the document TABLE OF
Use these links to rapidly review the document TABLE OF

... Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking state ...
as terbinafine base
as terbinafine base

... occur in patients treated with terbinafine tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with terbinafine tablets. Carcinogenesis and Mutagenesis An increase in liver tumours was observed in male rats ...
AusPAR Ledipasvir / Sofosbuvir - Therapeutic Goods Administration
AusPAR Ledipasvir / Sofosbuvir - Therapeutic Goods Administration

... The TGA administers the Therapeutic Goods Act 1989, applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. ...
to the Akten FAQs PDF
to the Akten FAQs PDF

... for Injection as inactive ingredients in the 1 mL tube configuration. Akten® contains Hypromellose, Sodium Chloride, and Purified Water as inactive ingredients in the 5 mL in the 10 mL bottle configuration. The pH may be adjusted to 5.5 to 7.5 with Hydrochloric Acid and/or Sodium Hydroxide. ...
AusPAR: Buprenorphine - Therapeutic Goods Administration
AusPAR: Buprenorphine - Therapeutic Goods Administration

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. ...
Azithromycin for Injection, USP
Azithromycin for Injection, USP

... The pharmacokinetics of azithromycin in subjects with hepatic impairment has not been established. Gender There are no significant differences in the disposition of azithromycin between male and female subjects. No dosage adjustment is recommended based on gender. Geriatric Patients Pharmacokinetic ...
adaptimmune therapeutics plc - Corporate
adaptimmune therapeutics plc - Corporate

... This Quarterly Report contains forward-looking statements that are based on our current expectations, assumptions, estimates and projections about us and our industry. All statements other than statements of historical fact in this Quarterly Report are forward-looking statements. These forward-looki ...
PDF - International Psoriasis Council
PDF - International Psoriasis Council

... COMMENTARY IL-17A has recently been implicated as having a role in both psoriatic arthritis and other seronegative spondylarthropathies. Brodalumab is one of three new drugs that target IL-17 and are currently in clinical trials or have just completed phase III trials for the treatment of psoriasis. ...
Deferasirox for the treatment of iron overload associated with regular
Deferasirox for the treatment of iron overload associated with regular

... Second, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions besp ...
Optimal asthma control, starting with high doses of inhaled budesonide
Optimal asthma control, starting with high doses of inhaled budesonide

... higher than that recommended in international guidelines. The study had a parallel-group design and included 61 subjects with poorly controlled asthma, randomized to receive 3,200 mg or 1,600 mg budesonide daily by Turbuhaler1 for 8 weeks (double-blind), then 1,600 mg.day-1 for 8 weeks (single-blind ...
AusPAR: Trastuzumab emtansine - Therapeutic Goods Administration
AusPAR: Trastuzumab emtansine - Therapeutic Goods Administration

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Prescribing Information
Prescribing Information

... that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking PROVIGIL, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Prescribers should ...
Artemisia annua(Sweet Annie), Other Artemisia Species, Artemisinin
Artemisia annua(Sweet Annie), Other Artemisia Species, Artemisinin

... In 1972, Chinese scientists isolated qinghaosu (artemisinin) from A. annua. They were looking at this plant very specifically because they took Ge Hong’s writings about qinghao from over 1000 years before seriously (as opposed to many researchers in the west who look upon historical herbal books as ...
Ceftolozane (as sulfate) / Tazobactam (as sodium salt)
Ceftolozane (as sulfate) / Tazobactam (as sodium salt)

... S= susceptible, I=intermediate, R=resistant ...
Assessing the research potential of access to
Assessing the research potential of access to

... UK), Matt Sydes (Medical Research Council Clinical Trials Unit at University College London), and Catrin Tudur Smith (University of Liverpool). ...
Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir
Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir

... As adherence to ARV drug regimen is important in preventing viral rebound and to reduce risk of drug resistance development, fixed-dose combination single-tablet regimens (STRs) have been developed to improve compliance. Currently in Australia, there are 2 NNRTI/N(t)RTI based-STRs approved for once- ...
The use of MElatonin in children with Neurodevelopmental
The use of MElatonin in children with Neurodevelopmental

... Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions besp ...
Abilify Maintena
Abilify Maintena

... minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs and (2) for whom alternative, equally effective, but potentially less harmful treatments are ...
DOC - Stemline Therapeutics, Inc.
DOC - Stemline Therapeutics, Inc.

... This annual report on Form 10-K (“Form 10-K”) includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expect ...
Sedation for diagnostic and therapeutic procedures in children and
Sedation for diagnostic and therapeutic procedures in children and

... reassurance. In children and young people this is often not possible because the procedures are too frightening, too painful or need to be carried out in children who may be ill, in pain or have behavioural problems. The aims of sedation during diagnostic or therapeutic procedures include reducing f ...
Pharmacokinetic Interaction Between Prasugrel and Ritonavir
Pharmacokinetic Interaction Between Prasugrel and Ritonavir

... tablets; consumed alcohol regularly; had concomitant disease; or used any drug or food such as grapefruit in the month prior to the study that can either affect or be metabolized by CYP3A, 2C19, 2B6 and 2C9. Volunteers who used drugs associated with an increased risk of bleeding in the 10 days prece ...
PRODUCT MONOGRAPH COMBIGAN®
PRODUCT MONOGRAPH COMBIGAN®

... Precautions for considerations during use in this population. Patients using Systemic Beta-blockers: Results from pivotal trials indicate that the mean change from baseline IOP was significantly lower (p < 0.001) with COMBIGAN® than with either brimonidine tartrate alone or timolol maleate alone for ...
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Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.Only 10% of all drugs started in human clinical trials become an approved drug.
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