Investigator
... assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use ...
... assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use ...
Be Prepared (If not, you won’t know what hit you.)
... Chances of “equivalence” conclusions faint as even a single amino acid can throw off conclusion (e.g., HGH) Lovenox – only 70% characterized (but, is under an NDA) ...
... Chances of “equivalence” conclusions faint as even a single amino acid can throw off conclusion (e.g., HGH) Lovenox – only 70% characterized (but, is under an NDA) ...
An Integrated Clinical Trials System Utilizing Client Server and Graphical User Interface Technology
... length of time required to introduce new drugs around the world, the pharmaceutical industry and regulatory agencies such as the U.S. Food and Drug Administration have sought to facilitate the drug development and approval processes through innovative uses of computer technology. One such effort tha ...
... length of time required to introduce new drugs around the world, the pharmaceutical industry and regulatory agencies such as the U.S. Food and Drug Administration have sought to facilitate the drug development and approval processes through innovative uses of computer technology. One such effort tha ...
How to process data from clinical trails and their open label extensions
... Patients participating in double-blind controlled pivotal trials are often transferred into long-term open label extension trials after completion of the main part of the trial. These trials are often requested to offer patients benefiting from a new drug treatment the possibility to receive the dru ...
... Patients participating in double-blind controlled pivotal trials are often transferred into long-term open label extension trials after completion of the main part of the trial. These trials are often requested to offer patients benefiting from a new drug treatment the possibility to receive the dru ...
Developing Clinical Questions
... Ask “What is the main intervention I am considering?” and “What is the main comparison/control?” Be specific, but consider feasible alternatives. ...
... Ask “What is the main intervention I am considering?” and “What is the main comparison/control?” Be specific, but consider feasible alternatives. ...
The European Cancer Congress 2013
... results for monotherapy Yervoy has reignited excitement around the anti-PD-1 and anti-CTLA-4 combination. The success of Yervoy monotherapy in melanoma has been a catalyst for immunotherapy drug development in this indication in recent years. Nivolumab is the most advanced anti-PD-1 in development a ...
... results for monotherapy Yervoy has reignited excitement around the anti-PD-1 and anti-CTLA-4 combination. The success of Yervoy monotherapy in melanoma has been a catalyst for immunotherapy drug development in this indication in recent years. Nivolumab is the most advanced anti-PD-1 in development a ...
Meta-analysis of clinical trials as a scientific discipline. II: Replicate
... We have found 86 meta-analyses published in the English language by MEDLINE searches, reviews of ‘Current Contents’, and obtaining references from published review articles and other meta-analyses. The technique of meta-analysis is new enough not to be routinely indexed under the terms ‘meta-analy~i ...
... We have found 86 meta-analyses published in the English language by MEDLINE searches, reviews of ‘Current Contents’, and obtaining references from published review articles and other meta-analyses. The technique of meta-analysis is new enough not to be routinely indexed under the terms ‘meta-analy~i ...
https://www.ubhonline.com/html/guidelines/index
... response to a request from a network provider for re-examination, and in response to a pilot project proposed for United Behavioral Health, as well as the span of time that has elapsed since the original review. Date Re-Review Approved by the Clinical Technology Assessment Committee: March 29, 2010 ...
... response to a request from a network provider for re-examination, and in response to a pilot project proposed for United Behavioral Health, as well as the span of time that has elapsed since the original review. Date Re-Review Approved by the Clinical Technology Assessment Committee: March 29, 2010 ...
The Psychedelic Renaissance: Horizons, the Fifth Annual Conference on Psychedelic Research
... by the 240-item NEO Personality Inventory used in contemporary psychology to describe human personality, is based on an examination of various specific facets. These facets include fantasy (e.g., “I have a very active imagination”), aesthetics (e.g., “I am intrigued by patterns I find in art and natu ...
... by the 240-item NEO Personality Inventory used in contemporary psychology to describe human personality, is based on an examination of various specific facets. These facets include fantasy (e.g., “I have a very active imagination”), aesthetics (e.g., “I am intrigued by patterns I find in art and natu ...
ccr5 antagonists in the treatment of treatment
... infection. This is the first medication belonging to the new class of CCR5 antagonists, and the first approval of an oraly available drug in a new class since 1996. Yet another new class, the integrase inhibitors, are available in expanded access programs and are likely to become approved in 2007. T ...
... infection. This is the first medication belonging to the new class of CCR5 antagonists, and the first approval of an oraly available drug in a new class since 1996. Yet another new class, the integrase inhibitors, are available in expanded access programs and are likely to become approved in 2007. T ...
this PDF file
... by the 240-item NEO Personality Inventory used in contemporary psychology to describe human personality, is based on an examination of various specific facets. These facets include fantasy (e.g., “I have a very active imagination”), aesthetics (e.g., “I am intrigued by patterns I find in art and natu ...
... by the 240-item NEO Personality Inventory used in contemporary psychology to describe human personality, is based on an examination of various specific facets. These facets include fantasy (e.g., “I have a very active imagination”), aesthetics (e.g., “I am intrigued by patterns I find in art and natu ...
Project submission form for human involvement study
... appropriately trained and will adhere to the provisions of the Institutional Ethics Committee. TMC, approved protocol. All data collected during the research project, including those supported by commercial sponsors (e.g. pharmaceutical company), will remain the property of Tata Memorial Centre or a ...
... appropriately trained and will adhere to the provisions of the Institutional Ethics Committee. TMC, approved protocol. All data collected during the research project, including those supported by commercial sponsors (e.g. pharmaceutical company), will remain the property of Tata Memorial Centre or a ...
Manuscript "Fast-track drug approval in inflammatory bowel diseases"
... c) Which currently (or soon to be) approved IBD drugs would have met the criteria for fast track review and what would the outcome have been if they had been subject to this process This is a very interesting question. The following statement was added in our manuscript. “An interesting question wou ...
... c) Which currently (or soon to be) approved IBD drugs would have met the criteria for fast track review and what would the outcome have been if they had been subject to this process This is a very interesting question. The following statement was added in our manuscript. “An interesting question wou ...
Subcutaneous Trastuzumab in Advanced Breast Cancer
... the treatment to go ahead (measured on echocardiography (ECHO) or multigated acquisition (MUGA). Cardiac monitoring is carried out at baseline, at 4 and 8 months. Beyond this, LVEF should be monitored every 6 months as clinically indicated. A further end of treatment assessment is recommended in pat ...
... the treatment to go ahead (measured on echocardiography (ECHO) or multigated acquisition (MUGA). Cardiac monitoring is carried out at baseline, at 4 and 8 months. Beyond this, LVEF should be monitored every 6 months as clinically indicated. A further end of treatment assessment is recommended in pat ...
Evaluation of new antiemetic agents and definition of
... impact of prognostic factors can be analyzed by a multifactorial analysis at the end of the study. Other patient characteristics such as increased fatigue, low social functioning, and pre-existing nausea may also be of importance [13]. A randomized, parallel double-blind study is the preferred desig ...
... impact of prognostic factors can be analyzed by a multifactorial analysis at the end of the study. Other patient characteristics such as increased fatigue, low social functioning, and pre-existing nausea may also be of importance [13]. A randomized, parallel double-blind study is the preferred desig ...
Document
... made in the course of the presentation are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the ...
... made in the course of the presentation are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the ...
Guideline on clinical investigation of new medicinal
... Comment: The guidance states that if the investigation drug has a different mechanism to that of standard therapy then it should be given in addition to standard therapy in the study. While this has been how drugs have been developed for this population of patients to date, looking at some recent fa ...
... Comment: The guidance states that if the investigation drug has a different mechanism to that of standard therapy then it should be given in addition to standard therapy in the study. While this has been how drugs have been developed for this population of patients to date, looking at some recent fa ...
Expanded Access For An Unapproved Drug
... An unapproved test item (i.e., drug, biologic, or medical device) may only be used on human subjects through a Food and Drug Administration (FDA)-approved clinical study in which patients meet certain criteria and the test item is only used in accordance with an approved protocol by a clinical inves ...
... An unapproved test item (i.e., drug, biologic, or medical device) may only be used on human subjects through a Food and Drug Administration (FDA)-approved clinical study in which patients meet certain criteria and the test item is only used in accordance with an approved protocol by a clinical inves ...
Kyowa Hakko Kirin and Bristol-Myers Squibb Announce Immuno
... 2012 for the treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cel ...
... 2012 for the treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cel ...
Emergency Management of the Acutely Poisoned Patient
... Salicylates Methamphetamine and ecstasy Diazepam and other benzodiazepines ...
... Salicylates Methamphetamine and ecstasy Diazepam and other benzodiazepines ...
Oncology KOLS: AN IMPORTANT PIECE OF THE PUZZLE
... challenged by access concerns and high costs of cancer therapies. Earlier diagnosis, longer treatment durations, and increased effectiveness of drug therapies are contributing to rising levels of spending on medicines for cancer care. The need to address these concerns and provide more complex scien ...
... challenged by access concerns and high costs of cancer therapies. Earlier diagnosis, longer treatment durations, and increased effectiveness of drug therapies are contributing to rising levels of spending on medicines for cancer care. The need to address these concerns and provide more complex scien ...
Use and Perceived Benefits of Handheld Computer
... specialty (Table 1). We did not have practice location data for the non-respondents. When compared to the most recent national demographic data (2003), survey respondents were more likely male (86 vs. 74%) and practiced in family/ general practice (27 vs. 12%) and the internal medicine subspecialtie ...
... specialty (Table 1). We did not have practice location data for the non-respondents. When compared to the most recent national demographic data (2003), survey respondents were more likely male (86 vs. 74%) and practiced in family/ general practice (27 vs. 12%) and the internal medicine subspecialtie ...
Data Challenges in Adaptive Trials
... the only two doses which are explored in traditional studies. As ineffective treatments or doses can be dropped earlier, the risk for the patients enrolled in the study can be lowered with an adaptive design. Adaptive trials also yield additional risks over traditional studies, in terms of i) regula ...
... the only two doses which are explored in traditional studies. As ineffective treatments or doses can be dropped earlier, the risk for the patients enrolled in the study can be lowered with an adaptive design. Adaptive trials also yield additional risks over traditional studies, in terms of i) regula ...
FULL PRESCRIBING INFORMATION: CONTENTS* WARNING
... postnatal days 7 and 14, respectively (human age equivalent of approximately 1 month to less than 2 years). Treatment-related increases in the weight of intestinal contents were observed in juvenile mice following single doses of plecanatide on postnatal day 14 (human age equivalent of approximately ...
... postnatal days 7 and 14, respectively (human age equivalent of approximately 1 month to less than 2 years). Treatment-related increases in the weight of intestinal contents were observed in juvenile mice following single doses of plecanatide on postnatal day 14 (human age equivalent of approximately ...