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 ...
... 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
... 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. ...
... 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
... 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 ...
... 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
... 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”, ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ( ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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)
... 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 ...
... 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
... 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. ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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 ...
... 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
... 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. ...
... 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)
... 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 ...
... 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
... • 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 ) • ...
... • 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
... 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 ...
... 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
... Atrial fibrillation characteristics; Presence of cardiovascular diseases; Patient age and medical conditions; Treatment goals6. ...
... Atrial fibrillation characteristics; Presence of cardiovascular diseases; Patient age and medical conditions; Treatment goals6. ...