AMGEN.Press.Academy. Tom Lillie, MD, PhD Oncology
... effective therapies); minimise unnecessary toxicity (many therapies are often associated with unpleasant and even life threatening side effects), and reduce overall costs (administering agents to individuals who do not respond is not cost effective). The power of predictive biomarkers in oncology is ...
... effective therapies); minimise unnecessary toxicity (many therapies are often associated with unpleasant and even life threatening side effects), and reduce overall costs (administering agents to individuals who do not respond is not cost effective). The power of predictive biomarkers in oncology is ...
PDF - E
... with those who do not receive early fibrinogen supplementation. This study will be conducted only at centres with sufficient laboratory haemostasis expertise. As many as 4 in every 10 patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have an abnor ...
... with those who do not receive early fibrinogen supplementation. This study will be conducted only at centres with sufficient laboratory haemostasis expertise. As many as 4 in every 10 patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have an abnor ...
Deutsche Bank 36th Annual Health Care Conference
... Comprises a proprietary Xencor modification that leads to rapid and sustained B-cell depletion ...
... Comprises a proprietary Xencor modification that leads to rapid and sustained B-cell depletion ...
Meeting the Future in Managing Chronic Disorders
... the following: – To compare the value of two estimated policies (both estimated using the training data). – To assess if there is sufficient evidence that a particular observation (e.g. output of a biological test) should be part of the policy. – To assess if there is sufficient evidence that a subs ...
... the following: – To compare the value of two estimated policies (both estimated using the training data). – To assess if there is sufficient evidence that a particular observation (e.g. output of a biological test) should be part of the policy. – To assess if there is sufficient evidence that a subs ...
8-K - corporate
... initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical development process, including a ...
... initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical development process, including a ...
Through the Looking Glass: Reflections of a Research Ethicist or
... millions of prescriptions for the drug have been written for patients with type 2 diabetes. Rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States. ...
... millions of prescriptions for the drug have been written for patients with type 2 diabetes. Rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States. ...
Poster presentation
... Outcome Measures: Individual patient data analysis in the above four domains (assessment prior to ART; prescribing patterns; monitoring for efficacy/safety of therapy; and clinical, virological outcomes); changes in physicians’ knowledge about rational use of ARTs. Results: 41% of patients had no re ...
... Outcome Measures: Individual patient data analysis in the above four domains (assessment prior to ART; prescribing patterns; monitoring for efficacy/safety of therapy; and clinical, virological outcomes); changes in physicians’ knowledge about rational use of ARTs. Results: 41% of patients had no re ...
Randomized Clinical Trials - Statistical Rules of Thumb
... a pharmaceutical firm; it is not uncommon to have a cost-sharing arrangement. With a pharmaceutical or device firm involved, there also arise the issues of who owns the data, to what extent can the firm influence publications of papers, the specter of conflict of interest, and so on. • The randomized cli ...
... a pharmaceutical firm; it is not uncommon to have a cost-sharing arrangement. With a pharmaceutical or device firm involved, there also arise the issues of who owns the data, to what extent can the firm influence publications of papers, the specter of conflict of interest, and so on. • The randomized cli ...
203469Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S)
... gastrointestinal perforations, proteinuria and hypertension are similar to the risks reported with VEGF-receptor kinases and are listed in the warning sections of their respective labels for one or more of the following VEGF-receptor kinase inhibitors: axitinib, bevacizumab, pazopanib, regorafenib, ...
... gastrointestinal perforations, proteinuria and hypertension are similar to the risks reported with VEGF-receptor kinases and are listed in the warning sections of their respective labels for one or more of the following VEGF-receptor kinase inhibitors: axitinib, bevacizumab, pazopanib, regorafenib, ...
Slide 1
... attack, and revascularizations (e.g., coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial. This independent board notified Pfizer of the mortality finding early the morning of December 2, 2006 and FDA was notified at 4:00 PM EST that evening that Pfizer planned ...
... attack, and revascularizations (e.g., coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial. This independent board notified Pfizer of the mortality finding early the morning of December 2, 2006 and FDA was notified at 4:00 PM EST that evening that Pfizer planned ...
Glossary of Clinical Trial Terms
... including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) in the United States or Marketing Authorization Application (MAA) in Europe by the manufacturer, regulatory agency review of the application, and agency approval/rejection of appl ...
... including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) in the United States or Marketing Authorization Application (MAA) in Europe by the manufacturer, regulatory agency review of the application, and agency approval/rejection of appl ...
Winter 2016 - California Retina Research Foundation
... ly successful over the past decade in treating wet (neovascular) age-related macular degeneration (AMD), however they can require monthly patient visits and frequent injections. CRRF is involved in several clinical trials aimed at reducing the treatment burden on patients. Some involve new medicatio ...
... ly successful over the past decade in treating wet (neovascular) age-related macular degeneration (AMD), however they can require monthly patient visits and frequent injections. CRRF is involved in several clinical trials aimed at reducing the treatment burden on patients. Some involve new medicatio ...
PPT - ACoP
... In response to the current decline in the approval of new analgesic medicines the FDA has recently launched the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) initiative with the aim ‘‘to streamline the discovery and development process for new analgesic drug products for ...
... In response to the current decline in the approval of new analgesic medicines the FDA has recently launched the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) initiative with the aim ‘‘to streamline the discovery and development process for new analgesic drug products for ...
research_proposal
... restriction assumption that the outcome under zero cumulative dose is the same as the outcome under the placebo dose. Although active-controlled trials lack a reference group of unexposed participants, the randomization mechanism can help identify causal exposure-response relationships under more re ...
... restriction assumption that the outcome under zero cumulative dose is the same as the outcome under the placebo dose. Although active-controlled trials lack a reference group of unexposed participants, the randomization mechanism can help identify causal exposure-response relationships under more re ...
Job Description
... The postholder may be required to carry out other relevant duties as required. The postholder will adhere to the duties specified under the Staff Responsibilities of the NHS Constitution in their day to day work and behaviours. The postholder will be expected to aspire to the Values of the Trust in ...
... The postholder may be required to carry out other relevant duties as required. The postholder will adhere to the duties specified under the Staff Responsibilities of the NHS Constitution in their day to day work and behaviours. The postholder will be expected to aspire to the Values of the Trust in ...
The Investigational New Drug (IND) and New Drug Application (NDA)
... Clarification of Policy on INDs for Studies of Marketed Products • Submission of an IND to study a marketed drug or biologic product not required when: – Product used in generally the same patient population and same manner for which the agent was approved (ie, will not substantially increase patie ...
... Clarification of Policy on INDs for Studies of Marketed Products • Submission of an IND to study a marketed drug or biologic product not required when: – Product used in generally the same patient population and same manner for which the agent was approved (ie, will not substantially increase patie ...
Serotonin and Depression: A Clinical Perspective
... severity by at least 50% following treatment – It may mean a failure to reduce absolute depressive score below a specific cut point – It may mean a failure of symptoms to entirely remit – It may mean failure to respond to one or more ...
... severity by at least 50% following treatment – It may mean a failure to reduce absolute depressive score below a specific cut point – It may mean a failure of symptoms to entirely remit – It may mean failure to respond to one or more ...
Practice Guidelines from Randomized Clinical Trials
... • In late ‘50’s and early ‘60’s it was recommended to pregnant women by their OB/GYN’s to control morning sickness. • Later found to cause serious birth defects and miscarriages. • Led to serious birth defects of more than 10,000 children. ...
... • In late ‘50’s and early ‘60’s it was recommended to pregnant women by their OB/GYN’s to control morning sickness. • Later found to cause serious birth defects and miscarriages. • Led to serious birth defects of more than 10,000 children. ...
Imaging in Clinical Development of Cancer Drugs
... • Even FDG-PET: relatively few multi-center results reported • E.g., only now, are multi-center studies underway to confirm the association between FDG-PET response and clinical outcome from standard therapy in common cancers: – Non-small cell lung cancer: ACRIN 6678 – Non-Hodgkin Lymphoma: CALGB 58 ...
... • Even FDG-PET: relatively few multi-center results reported • E.g., only now, are multi-center studies underway to confirm the association between FDG-PET response and clinical outcome from standard therapy in common cancers: – Non-small cell lung cancer: ACRIN 6678 – Non-Hodgkin Lymphoma: CALGB 58 ...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE
... suffering from acute diarrhoea of miscellaneous severity and treated as in- or out-patients The median age was 12 months (interquartile range: 6 to 39 months). A total of 714 patients were < 1 year and 670 patients were > 1 year old. Mean weight ranged from 7.4 kg to to 12.2 kg across studies. The o ...
... suffering from acute diarrhoea of miscellaneous severity and treated as in- or out-patients The median age was 12 months (interquartile range: 6 to 39 months). A total of 714 patients were < 1 year and 670 patients were > 1 year old. Mean weight ranged from 7.4 kg to to 12.2 kg across studies. The o ...
Mantle Cell Lymphoma: Relapsed/Refractory
... of treatment options available for these patients. The type of ...
... of treatment options available for these patients. The type of ...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE
... patient and the stage and severity of the condition, specifically in case of serious or prolonged diarrhoea with significant vomiting or a lack of appetite In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered. The ...
... patient and the stage and severity of the condition, specifically in case of serious or prolonged diarrhoea with significant vomiting or a lack of appetite In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered. The ...
Personalized Medicine - Quo Vadis
... controls, i.e. we don’t know how a patient with the same genetic variation would progress without treatment ...
... controls, i.e. we don’t know how a patient with the same genetic variation would progress without treatment ...
Foundation Fighting Blindness
... strategies. As part of this effort, the Foundation has established an on-line interactive patient registry, My Retina Tracker, which provides resources for patients, researchers, and clinicians. The Foundation has set up milestones for its activities under a 2011-2016 Strategic Plan. By 2016, FFB ai ...
... strategies. As part of this effort, the Foundation has established an on-line interactive patient registry, My Retina Tracker, which provides resources for patients, researchers, and clinicians. The Foundation has set up milestones for its activities under a 2011-2016 Strategic Plan. By 2016, FFB ai ...
