• Study Resource
  • Explore
    • Arts & Humanities
    • Business
    • Engineering & Technology
    • Foreign Language
    • History
    • Math
    • Science
    • Social Science

    Top subcategories

    • Advanced Math
    • Algebra
    • Basic Math
    • Calculus
    • Geometry
    • Linear Algebra
    • Pre-Algebra
    • Pre-Calculus
    • Statistics And Probability
    • Trigonometry
    • other →

    Top subcategories

    • Astronomy
    • Astrophysics
    • Biology
    • Chemistry
    • Earth Science
    • Environmental Science
    • Health Science
    • Physics
    • other →

    Top subcategories

    • Anthropology
    • Law
    • Political Science
    • Psychology
    • Sociology
    • other →

    Top subcategories

    • Accounting
    • Economics
    • Finance
    • Management
    • other →

    Top subcategories

    • Aerospace Engineering
    • Bioengineering
    • Chemical Engineering
    • Civil Engineering
    • Computer Science
    • Electrical Engineering
    • Industrial Engineering
    • Mechanical Engineering
    • Web Design
    • other →

    Top subcategories

    • Architecture
    • Communications
    • English
    • Gender Studies
    • Music
    • Performing Arts
    • Philosophy
    • Religious Studies
    • Writing
    • other →

    Top subcategories

    • Ancient History
    • European History
    • US History
    • World History
    • other →

    Top subcategories

    • Croatian
    • Czech
    • Finnish
    • Greek
    • Hindi
    • Japanese
    • Korean
    • Persian
    • Swedish
    • Turkish
    • other →
 
Profile Documents Logout
Upload
Notice to Applicants
Notice to Applicants

... Reformatting of dossiers of already authorised products: There is no obligation to reformat the dossier of already authorised medicinal products into the new EU-CTD format. If a marketing authorisation holder (MAH) wishes to reformat the documentation, such reformatting will be allowed, although it ...
Australian public assessment for everolimus
Australian public assessment for everolimus

... 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. ...
Analysis
Analysis

... the care of people with hemophilia (Miners 2004; Miners 2009), and it prevents its extensive application worldwide. Furthermore, there is no general agreement on the optimal prophylaxis regimen, and some schemes differ from that proposed by the European Paediatric Network which has been recently pro ...
Biota Pharmaceuticals, Inc. (Form: 10
Biota Pharmaceuticals, Inc. (Form: 10

... On November 8, 2012, Nabi Pharmaceuticals, Inc. (“Nabi”) and Biota Holdings Limited, a biopharmaceutical company based in Melbourne, Australia that had been listed on the Australian Stock Exchange since 1985, completed a merger, and renamed the resulting company Biota Pharmaceuticals, Inc. (“Biota”, ...
ASMANEX™ TWISTHALER™ PRODUCT MONOGRAPH
ASMANEX™ TWISTHALER™ PRODUCT MONOGRAPH

... Osteoporosis and fracture are major complications of long-term asthma treatment with parenteral or oral steroids. Inhaled corticosteroid therapy is also associated with dose-dependent bone loss although the degree of risk is less than with oral steroids. It is not yet known whether the peak bone den ...
Newsletter - SAKK – Swiss Group for Clinical Cancer Research
Newsletter - SAKK – Swiss Group for Clinical Cancer Research

... a patient representative board to advise the organization on communication, trial development and strategy. «By partnering with the SAKK patient representative board, we intend to improve the dialogue between scientists and patients», says CEO Dr. Peter Brauchli. «Moreover, we are hoping this will g ...
Guidelines for the management of adult lower respiratory
Guidelines for the management of adult lower respiratory

... put forward as definitions to guide the clinician, but it will be seen in the ensuing text that some of these labels will always be inaccurate. These definitions are pragmatic and based on a synthesis of available studies. They are primarily meant to be simple to apply in clinical practice, and this m ...
Guidelines for the management of adult lower respiratory tract
Guidelines for the management of adult lower respiratory tract

... put forward as definitions to guide the clinician, but it will be seen in the ensuing text that some of these labels will always be inaccurate. These definitions are pragmatic and based on a synthesis of available studies. They are primarily meant to be simple to apply in clinical practice, and this ...
Guideline Index
Guideline Index

... American Heart Association (59) American Institute of Ultrasound in Medicine (1) American Medical Association (3) American Medical Directors Association (19) American Optometric Association (16) American Pain Society (3) American Pain Society Fibromyalgia Panel (1) American Psychiatric Association ( ...
Antiemetics for reducing vomiting related to acute gastroenteritis in
Antiemetics for reducing vomiting related to acute gastroenteritis in

... comprehensive electronic database searches and hand searches of relevant journals and abstract books of conferences.The search was re-run and is up to date as on 20 July 2010. Selection criteria Randomized controlled trials comparing antiemetics with placebo or no treatment, in children and adolesce ...
product monograph - Eli Lilly Canada
product monograph - Eli Lilly Canada

... myoglobinuria (rhabdomyolysis), and acute renal failure. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.), and untreated or inadequately treated extrapyramidal signs and sym ...
Determination of 19 Cardiac Troponin I and T
Determination of 19 Cardiac Troponin I and T

... values from 19 to 18 ng/L (OCD-Vitros), and 184 to ⬍160 ng/L (Roche); 99th percentile values for the Siemens Centaur Ultra assay were not changed following data exclusion. Only the Beckman assay determined measurable concentrations of cTnI in a substantial fraction of study participants, 35%. All th ...
CDR Clinical Review Report for Botox (Migraine)
CDR Clinical Review Report for Botox (Migraine)

... The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a s ...
Communications - Canadian Rheumatology Association
Communications - Canadian Rheumatology Association

... 1. Kennish LM, et al. Presented at ACR 2011; Presentation #314. 2. Nicolau J, et al. Presented at ACR 2011; Presentation #315. 3. Ortiz Garcia AM, et al. Presented at ACR 2011; Presentation #319. ...
Guidelines for Assessing Systematic Reviews
Guidelines for Assessing Systematic Reviews

... paper that was published. However, other databases such as clinical trial registries may only indicate that a study was planned, and follow-up with the investigator or sponsor is needed to determine if findings were published, or at least are available. These abstracts are used to screen studies/pap ...
A Review of the Use of the Number Needed to Treat to Evaluate the
A Review of the Use of the Number Needed to Treat to Evaluate the

... treatment as the control to calculate the NNT. The choice of controls has a huge impact on the NNT values and their interpretations. Thus, any comparison of NNT values must use the same controls for calculations; comparing NNT values calculated with different control groups would not be valid. There ...
Placebo effects: clinical aspects and neurobiology
Placebo effects: clinical aspects and neurobiology

... than others. While some studies have been negative (Freund et al., 1972; Buckalew et al., 1981), other studies suggest there may be some contribution to the placebo response from factors such as social acquiescence (McNair and Barrett, 1979), suggestibility or hypnotizability and absorption, which i ...
MSLT perameter.qxp - American Academy of Sleep Medicine
MSLT perameter.qxp - American Academy of Sleep Medicine

... usefulness of the MSLT, and a small but significant group of studies specifically address the operating characteristics of the MSLT as a diagnostic test. The Maintenance of Wakefulness Test (MWT), another laboratory-based objective measure of sleepiness/wakefulness, was not covered in the original p ...
PRODUCT MONOGRAPH PrCELEBREX ® (celecoxib) Capsules
PRODUCT MONOGRAPH PrCELEBREX ® (celecoxib) Capsules

... Use of NSAIDs, such as CELEBREX, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renal-mediated mechanism (see WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance). For patients with a high risk of developing an adverse CV event, other manag ...
Surgical and Ablative Procedures for Venous Insufficiency and
Surgical and Ablative Procedures for Venous Insufficiency and

... sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering heal ...
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir

... 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. ...
- Boehringer Ingelheim (Canada)
- Boehringer Ingelheim (Canada)

... under medical supervision during treatment. Recommended dose: The recommended dosage is 2 metered doses (actuations) (40 mcg) 3 or 4 times daily. Some patients may need up to 4 metered doses (actuations) (80 mcg) at a time to obtain maximum benefit during early treatment. Maximum daily dose: The max ...
THYROID DYSFUNCTION
THYROID DYSFUNCTION

... • Levothyroxine (LT4), narrow therapeutic range – 0.3 – 3.0 IU/mL, caution in lower range TSH. • Brand vs. generic vs. T4 + T3 combination. • Lifelong treatment, most cases • Dosing: 1.6 mcg/kg/day = ~100 - 125 mcg/day. • Compliance, empty stomach, competing agents for absorption (Iron, Calcium ) • ...
Guideline for the Quality, Safety, and Efficacy Assurance of Follow
Guideline for the Quality, Safety, and Efficacy Assurance of Follow

... For the development of a follow-on biologic, the manufacturing process should be established independently of that of the original biologic, and the quality attributes of the follow-on biologic should be thoroughly characterized, as in the case of new recombinant protein products. In addition, a hi ...
Free PDF - European Review for Medical and
Free PDF - European Review for Medical and

... Atrial fibrillation characteristics; Presence of cardiovascular diseases; Patient age and medical conditions; Treatment goals6. ...
< 1 ... 9 10 11 12 13 14 15 16 17 ... 170 >

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.
  • studyres.com © 2025
  • DMCA
  • Privacy
  • Terms
  • Report