• Ipsen has initiated two Phase II clinical studies to evaluate the efficacy and safety of BIM 23A760, a new drug to treat patients suffering from carcinoid syndrome due to neuroendocrine tumours. (pharmaceutical-technology.com)
  • The RAAINBOW study was a randomized, double-blind, phase 2/3 trial conducted at 12 sites in Germany and three other countries between March 2018 and March 2022 to evaluate the efficacy and safety of coacillium in the treatment of children and adolescents with moderate to severe alopecia areata. (medscape.com)
  • This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. (astrazenecaclinicaltrials.com)
  • During development, drug makers test their investigational drugs to identify risks and benefits, and work to minimize the risks - including those posed by drug-drug interactions. (fda.gov)
  • Still, major adverse drug interactions are preventable causes of morbidity and mortality. (fda.gov)
  • Issam Zineh, director of CDER's Office of Clinical Pharmacology, further highlights how drug interactions affect patients, and how FDA addresses the issue. (fda.gov)
  • Supplement-drug interactions are increasingly being scrutinized in the research setting because supplement use is fairly widespread. (fda.gov)
  • Who is at risk for drug-drug interactions? (fda.gov)
  • Why is it important to assess drug-drug interactions? (fda.gov)
  • Who should be most concerned about drug-drug interactions? (fda.gov)
  • These older adults, who are typically taking multiple medications for multiple conditions, are among those at highest risk for drug interactions, though it is important to note that serious drug interactions can happen to anyone. (fda.gov)
  • When and how do drug makers evaluate a new drug's potential for drug-drug interactions? (fda.gov)
  • Assessing changes in the eye movements of mice treated with CNS-active drugs could complement the existing range of in vivo tests to evaluate the therapeutic efficacy, pharmacokinetics, drug receptor interactions, and toxicity of a wide range of candidate drug compounds, researchers claim. (genengnews.com)
  • They found that treatment elicited distinctive and characteristic eye-movement responses that could be analyzed quantitatively to confirm drug dose, duration of action, receptor specificity, blood-brain barrier penetration, and agonist-antagonist interactions. (genengnews.com)
  • The researchers found these characteristic drug-related changes could be used to evaluate blood-brain barrier penetration of drugs and even drug-receptor interaction, drug-drug interactions, and detect acute lead toxicity. (genengnews.com)
  • Drug-drug interactions (DDIs) are an increasingly important clinical and public health concern as individuals with multiple chronic conditions are living longer and drug regimens are becoming more complex. (harvard.edu)
  • Electronic healthcare databases offer a valuable opportunity to evaluate the clinical consequences of potential DDIs and to identify interactions that are not detected during pre-marketing stages. (harvard.edu)
  • This thesis examines approaches to pharmacoepidemiologic studies of drug-drug interactions in electronic healthcare data, along with methodological challenges and potential sources of bias that can arise in this setting. (harvard.edu)
  • In Chapter 2, we evaluated several approaches to designing and analyzing case-crossover studies of drug-drug interactions based on two empirical DDI examples with prior evidence of harm. (harvard.edu)
  • The approach had high specificity and represents a promising option for generating the much-needed evidence on the relevance of drug-drug interactions in clinical practice, which was the primary motivation behind this dissertation. (harvard.edu)
  • PBBM / PBPK modeling & simulation software package which simulates all major dosing routes and drug-drug interactions (DDIs) in virtual human & animal population groups. (simulations-plus.com)
  • b Ritonavir-boosted nirmatrelvir has significant drug-drug interactions. (cdc.gov)
  • Clinicians should carefully review a patient's concomitant medications and evaluate potential drug-drug interactions. (cdc.gov)
  • February 23, 2021 -- Medical simulation software company Simulations Plus and the University of Pittsburgh Drug Discovery Institute (UPDDI) have jointly received a phase I grant from the U.S. National Institutes of Health (NIH)-funded Small Business Innovation Research (SBIR) grant to support their large-molecule safety collaboration. (scienceboard.net)
  • The global Phase III clinical trial proposed in the IND is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail. (pipelinereview.com)
  • Celltrion enrolled 24 healthy volunteers in a global Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63. (pipelinereview.com)
  • outcomes at follow-up phase will be evaluated at the last day of every period. (biomedcentral.com)
  • SEATTLE --(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. (gilead.com)
  • June 1, 2023 - ComboMATCH will comprise numerous phase 2 precision medicine cancer treatment trials that aim to identify promising drug combinations that can advance to larger clinical trials. (nih.gov)
  • Drug-induced nephrotoxicity is a common source of acute kidney injury (AKI) and a condition that complicates clinical outcomes of vulnerable patients. (simulations-plus.com)
  • A growing public health concern in senior patients, many of whom have multiple chronic conditions, polypharmacy paves the way for medication non-adherence, drug reactions, adverse events, and poor health outcomes, as well as increased use of healthcare services and rising costs. (businesswire.com)
  • Very often, when patients have been treated with empiric antimicrobial drugs, the culture results at the tertiary care institutions may be negative or do not detect the infecting organism. (cdc.gov)
  • Data from the Centers for Disease Control and Prevention's (CDC's) National Health and Nutrition Examination Survey tell us that about 20 percent of U.S. adults are taking three or more drugs, and likely, the prevalence is higher when we consider the number of patients taking two or more drugs. (fda.gov)
  • In Chapter 1, we evaluated whether the clinical impact of interaction between clopidogrel and cytochrome P450 (CYP) 2C19-inhibiting selective serotonin reuptake inhibitors (SSRIs) differed based on how patients encountered the interaction. (harvard.edu)
  • We found that in a case-crossover study of two drugs, a saturated model is a six-parameter model that differentiates all three ways patients can encounter an interaction. (harvard.edu)
  • Many of the criteria used to develop a fair distribution system for the United Network for Organ Sharing-such as a patient's age, severity of a patient's condition, and prognosis-are being considered for the Compassionate Use Advisory Committee, but the exact details for evaluating compassionate drug use requests and granting access to specific patients have not been -finalized. (ascopost.com)
  • Having this type of independent review panel tasked with weighing specific criteria for granting access to investigational drugs will create a more equitable, objective, and consistent system for desperate patients, said Dr. Caplan, and could help tamp down public outcry if the request is denied. (ascopost.com)
  • Right now, it looks like somebody in the drug company makes a decision, and patients don't know how or why the decision was made. (ascopost.com)
  • For example, if two TB patients were identified as having spent a prolonged period of time together in the same place but their isolate genotype patterns do not match, a second isolate should be submitted for genotyping to evaluate the possibility that an error occurred. (cdc.gov)
  • Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. (gilead.com)
  • The pilot will evaluate the ability of FeelBetter's SaaS solution to predict which senior patients, with multiple chronic conditions and complex medication regimens, are at risk of deterioration and hospitalization. (businesswire.com)
  • Researchers at the hospital will also evaluate how the FeelBetter solution can be used to identify patients who have the highest risk of deterioration, hospitalization and incurring financial costs from gaps in care, as well as how the technology can be leveraged to enable identification of potentially adverse medication prescriptions and combinations. (businesswire.com)
  • The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy. (astrazenecaclinicaltrials.com)
  • DURHAM, N.C.--(BUSINESS WIRE)-- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, has announced that it will present topline results from two studies evaluating VIVJOA™ (oteseconazole) capsules in patients with recurrent vulvovaginal candidiasis (RVVC) at the 2022 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. (pharmiweb.com)
  • In a second presentation, Mycovia will report on a post-hoc analysis that evaluated the efficacy of VIVJOA in RVVC patients with diabetes. (pharmiweb.com)
  • Health-care providers and their patients may opt to consider using antiretroviral drugs after nonoccupational HIV exposures that carry a high risk for infection, but only after careful consideration of the potential risks and benefits and with a full awareness of the gaps in current knowledge. (cdc.gov)
  • Health-care providers may want to provide their patients with a system for promptly initiating evaluation, counseling, and follow-up services after a reported sexual, injecting-drug-use, or other nonoccupational HIV exposure that might put a patient at high risk for acquiring infection. (cdc.gov)
  • However, these drugs can cause harm and provide no demonstrated benefit in patients with COVID-19 with no supplemental oxygen requirement or bacterial coinfection. (cdc.gov)
  • e Bebtelovimab is active in vitro against all circulating Omicron subvariants, but there are no clinical efficacy data from placebo-controlled trials that evaluated the use of bebtelovimab in patients who are at high risk of progressing to severe COVID-19. (cdc.gov)
  • To assess the extent to which a variety of CNS-active drugs might affect eye movements in mice, Dr. Nathan's team examined spontaneous and visual stimulus-induced eye movements after intraperiotneal injection of 48 drugs including antipsychotics, sedatives, antiseizure drugs, drugs of abuse such as cocaine, a CNS stimulate, and PTZ. (genengnews.com)
  • Evaluate makes it possible for us to assess the commercial value for different products, as well as understand the major trends in the pharmaceutical industry. (evaluate.com)
  • If successful, the new model could create a more equitable and consistent system for seeking investigational drugs. (ascopost.com)
  • I think Johnson & Johnson came to us because it wanted to try a different approach to granting requests for investigational drugs. (ascopost.com)
  • February 15, 2023 - Trial protocol may be adapted to evaluate additional therapeutics. (nih.gov)
  • Since both biological safety cabinets (BSCs), one-each within the positive pressure and negative pressure cleanrooms, were recently certified prior to the NIOSH visit, these were not quantitatively evaluated during the field survey. (cdc.gov)
  • This report contains CDC guidance that augments the 2011 recommendations of the Advisory Committee on Immunization Practices (ACIP) for evaluating hepatitis B protection among health-care personnel (HCP) and administering post-exposure prophylaxis. (cdc.gov)
  • This report emphasizes the importance of administering HepB vaccination for all HCP, provides explicit guidance for evaluating hepatitis B protection among previously vaccinated HCP (particularly those who were vaccinated in infancy or adolescence), and clarifies recommendations for postexposure management of HCP exposed to blood or body fluids. (cdc.gov)
  • Injecting-drug-use exposure through shared injection equipment can put a patient at risk for acquiring other viral infections (e.g., hepatitis B and hepatitis C). All persons evaluated for possible nonoccupational HIV exposure should be counseled to initiate, resume, or improve risk-reduction behaviors to avoid future exposure and to prevent possible secondary transmission until their current HIV infection status is determined. (cdc.gov)
  • One way to investigate this is to see whether risk of later drug use in the sequence, conditional on use of drugs earlier in the sequence, changes according to time-space variation in use prevalence. (nih.gov)
  • We compared patterns and order of initiation of alcohol, tobacco, cannabis, and other illicit drug use across 17 countries with a wide range of drug use prevalence. (nih.gov)
  • Initiation of "gateway" substances (i.e. alcohol, tobacco and cannabis) was differentially associated with subsequent onset of other illicit drug use based on background prevalence of gateway substance use. (nih.gov)
  • The hierarchical structure of the fibrous paper, modified with the synthesized Au@Ag core-shell nanoparticles (Au@Ag) possessing good SERS efficiency, enables us to evaluate the community-wide prevalence of methamphetamine in wastewater treatment plants around Beijing. (cranfield.ac.uk)
  • The findings from our latest Drug Index underscore the difficulties in ensuring commercial success for companies launching their first product," said Leslie Orne , President and CEO of Trinity Life Sciences. (businesswire.com)
  • A synopsis of the existing data for the various types of psychedelics is provided and we describe our findings with psychedelic drugs in these models. (erowid.org)
  • Here we report three key findings regarding the assessment of candidate drug targets using human loss-of-function variants. (bvsalud.org)
  • It is unclear whether the normative sequence of drug use initiation, beginning with tobacco and alcohol, progressing to cannabis and then other illicit drugs, is due to causal effects of specific earlier drug use promoting progression, or to influences of other variables such as drug availability and attitudes. (nih.gov)
  • The aim of this study was to evaluate spiritual and religious aspects in drug and/or alcohol users. (bvsalud.org)
  • In the sample, 47.1% were alcohol users, 52.9% drug users. (bvsalud.org)
  • History of chronic alcohol or drug abuse within 12 months. (astrazenecaclinicaltrials.com)
  • All questions were explored, but particular attention was paid to respondents' understandings of various substances (prescription pain relievers, non-prescription drugs, alcohol, and tobacco products) and treatment and counseling programs. (cdc.gov)
  • The potential effect of food on a drug product is routinely evaluated in drug development, and we are currently in the process of revising a guidance on that topic. (fda.gov)
  • FDA recently issued its guidance on abuse/dependence evaluation of drug-candidates (CDER/FDA, 2017). (erowid.org)
  • On April 30, 2019, the U.S. Department of Justice (DOJ) released updated guidance detailing how prosecutors will evaluate corporate compliance programs in charging and resolving criminal cases. (bricker.com)
  • Instead, the guidance recommends that prosecutors evaluate several metrics to determine efficacy of the compliance program, including the program's capacity to improve and evolve in response to new risks, the ability of the program to timely and thoroughly investigate allegations of misconduct, and the program's prior remediation of underlying misconduct. (bricker.com)
  • The DOJ's updated guidance provides a clear picture of the agency's process for evaluating compliance programs. (bricker.com)
  • June 27, 2023 - The investigational drug vorasidenib substantially slowed the growth of tumors in people with low-grade gliomas that had mutations in the IDH1 or IDH2 genes. (nih.gov)
  • May 15, 2023 - NIH-funded clinical trial will determine safety, tolerability of experimental drug. (nih.gov)
  • Wastewater-based epidemiology (WBE) is a powerful technique for monitoring illicit drugs of abuse in the community. (cranfield.ac.uk)
  • Industry partners have joined with research groups at the Medical Research Council Laboratory of Molecular Biology (MRC-LMB) and the University of Cambridge's Nanoscience Centre, to form the Cambridge Pharmaceutical Cryo-EM Consortium, with the aim to advance research in early-stage drug discovery. (labmate-online.com)
  • A medication is taken by a patient, gets absorbed into the bloodstream, and is distributed into different tissues or target organs where the drug exerts its pharmacological effect. (fda.gov)
  • Psychedelics comprise drugs come from various pharmacological classes including 5-HT2A agonists, indirect 5-HT agonists, e.g. (erowid.org)
  • Drug effects in humans are believed to be comprised of both direct pharmacological effects related to the drug itself and a placebo response (Kirsch 1985 ). (springer.com)
  • The report will also examine the impact of the COVID-19 pandemic on drug launches, relative to analyses in pre-pandemic years. (businesswire.com)
  • Continuing with the best model, the impact of the acceptor media and the importance of studying drug supersaturation in a combined dissolution-permeation model, as compared to a simple dissolution model, were evaluated. (pion-inc.com)
  • We argue that disease specific (rather than drug specific) registries, supervised by independent clinicians are urgently needed for the best long-term evaluation of treatments of these rare diseases. (biomedcentral.com)
  • Orphan drugs are often approved under exceptional circumstances, requiring submission of additional data on safety and effectiveness through registries. (biomedcentral.com)
  • For Fabry disease, two enzymes were authorized at the same time resulting in two different drug registries being required by the European Medicines Agency (EMA) to monitor effectiveness and safety. (biomedcentral.com)
  • Existing drug registries for evaluation of the effectiveness of treatments for some orphan diseases have certain limitations in this respect. (biomedcentral.com)
  • Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score. (mayo.edu)
  • Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score. (mayo.edu)
  • Although health-care providers and others have proposed offering antiretroviral drugs to persons with unanticipated sexual or injecting-drug-use HIV exposures (3,4), no data exist regarding the effectiveness of such therapy for these types of exposures. (cdc.gov)
  • All drugs inherently carry risks. (fda.gov)
  • We describe the non-clinical tests required for a regulatory evaluation of abuse/dependence risks, i.e., drug-discrimination, intravenous self-administration and physical dependence liability. (erowid.org)
  • Finally, we offer views on how these non-clinical tests can be refined to provide more meaningful information to aid the assessment of the risks posed by CNS drug-candidates for abuse and physical dependence. (erowid.org)
  • Nor has FDA explained how it will be evaluating PMTAs and structuring any permissive orders given the inevitable uncertainties when trying to determine the extent to which the marketing of a tobacco product might benefit or harm the public health or produce other health or non-health benefits, harms, or risks. (fdli.org)
  • Some populations are at higher risk, such as older adults who typically take more than one medication for chronic conditions, and people who take multiple drugs as part of standard treatment regimens for certain diseases. (fda.gov)
  • With VIVJOA now available in the U.S., we are grateful for this platform to share the growing body of data evaluating VIVJOA in women with chronic yeast infection. (pharmiweb.com)
  • NIOSH researchers also observed and interacted with the hospital's veterinarians and staff to obtain information about the hazardous drug work practices, daily activities, and oncology treatment processes. (cdc.gov)
  • These were collected in areas where the staff handled chemotherapy drugs, such as the oncology department. (cdc.gov)
  • The study showed CT-P63 to be safe and well tolerated, with no significant drug-related adverse events (AEs). (pipelinereview.com)
  • iv The purpose of this study was to 1) evaluate the relationship among cost, perceived benefit, perceived value and quantity of medication purchased, and 2) identify the major predictors of quantity of medication purchased. (auburn.edu)
  • however, Caco‐2 cell monolayers were considered too sensitive to be used to study drug supersaturation. (pion-inc.com)
  • Based on the ION-4 trial results, Gilead plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Harvoni to include the results from this study in the U.S. label. (gilead.com)
  • New approvals span a wide array of therapeutic areas, and over half of approvals received orphan drug designation. (businesswire.com)
  • The existing registries for orphan drug treatments for lysosomal storage disorders (LSD's) illustrate these limitations. (biomedcentral.com)
  • The European Union enacted the Orphan Drug Regulation in 2000 ( (EC) No 141/2000 and (EC) No 847/2000 ) in order to improve the availability of innovative medicines for diseases affecting less than 5/10 000 people. (biomedcentral.com)
  • If a drug interaction results in an increase of the concentration of a drug, the risk of side effects could be higher. (fda.gov)
  • According to the NAACP complaint, the two employees tested after speaking out at a ward meeting did not have drugs in their system, based on test results. (evanstonroundtable.com)
  • These results suggest the "gateway" pattern at least partially reflects unmeasured common causes rather than causal effects of specific drugs on subsequent use of others. (nih.gov)
  • After the Filling/Wire sweep analysis is done, Drag Force results will be available under Wire sweep results. (moldex3d.com)
  • By clicking X, Y, Z-Drag Force or Total Drag Force to display the distribution results, users can evaluate the wire sweep issue according to the force applied on the wires. (moldex3d.com)
  • Like drug-susceptibility test results, there is usually no benefit in testing additional isolates. (cdc.gov)
  • A second patient isolate should be submitted for genotyping when drug susceptibility results differ substantially among isolates from the same patient. (cdc.gov)
  • Although discrepant results can indicate that the patient's isolate has developed secondary drug resistance, the results may be caused by a false-positive culture. (cdc.gov)
  • Our results provide a roadmap for human knockout studies and should guide the interpretation of loss-of-function variants in drug development . (bvsalud.org)
  • NOTE: The expectation is that the data generated as an outcome of this research award, including but not necessarily limited to any individual replicate/subject-level data (not just summary results), any model constructs/code and data sets that represent an outcome of the award will be shared with the FDA Office of Generic Drugs (OGD) prior to the completion of the award period. (nih.gov)
  • It reflects a neuroadaptation that is the likelihood of drug-seeking behav- mediated gene transfer as a tool for neuropsychi- .nature the result of a powerful psychological iors, whereas administration of small atric research. (lu.se)
  • Researchers claim reproducible drug-related changes in OKR responses can be used with preclinical drug development tests. (genengnews.com)
  • For existing psychedelics in development, regulatory approval will require a move from schedule 1 to a CD schedule for drugs with medical use, i.e., schedules 2-5. (erowid.org)
  • It is particularly satisfying that pharmaceutical companies are keen to evaluate the approach for drug development. (labmate-online.com)
  • Quantitative Systems Toxicology (QST) software designed to be used during drug development to provide deeper insight into the mechanisms responsible for observed drug-induced liver injury (DILI) responses. (simulations-plus.com)
  • The four plant extracts are classified as "generally regarded as safe" ( GRAS ), Blume-Peytavi observed, noting that the development of coacillium fell under the category of a prescription botanical drug as set out by the US Food and Drug Administration or a herbal medicinal product as set out by the European Medicines Agency . (medscape.com)
  • Despite COVID-19 being a major headwind for products approved in 2019, there was not a statistical difference in the average commercial performance relative to 2017 and 2018 or a meaningful change in the proportion of drugs that failed to meet or exceed forecast expectations over the first two years post-launch. (businesswire.com)
  • The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued on 4-20-2017. (fda.gov)
  • Blume-Peytavi acknowledged that JAK inhibitors were "a tremendous advance in treating severe and very severe alopecia areata," but because of their benefit-to-risk ratio, there was still an unmet need for new treatments, particularly in children, in whom drug safety is of critical importance. (medscape.com)
  • 5. Carlezon, W.A. Jr. & Wise, R.A. Rewarding actions drug to its receptor, but rather by the rats, treatments associated with aversive of phencyclidine and related drugs in nucleus ac- failure of an expected drug injection to states such as severe drug withdrawal cumbens shell and frontal cortex. (lu.se)
  • Evidence suggests that placebo responses may account for a significant portion of the therapeutic response to drugs such as nicotine replacement therapies (Dar and Barrett 2014 ), antidepressants (Laferton et al. (springer.com)
  • The M39-A document provides a standardized means of data extraction for all drugs tested and outlines the most appropriate way to present the data ( 2 ). (cdc.gov)
  • This year's report, the fifth in Trinity's Drug Index series, outlines key themes and emerging trends as the life sciences industry moves towards a new world of targeted and innovative products. (businesswire.com)
  • Enteris BioPharma's latest whitepaper outlines the key parameters that drug developers should considering while evaluating oral delivery of peptides. (drug-dev.com)
  • The report also provides a deeper look into several drugs approved in 2019 with outstanding commercial performance, along with learnings from these launches. (businesswire.com)
  • A key finding in the report was the marked increase in the number of drugs approved within the neurology space, representing 23% of all new approvals in 2019 compared to 6% in 2018. (businesswire.com)
  • According to a 2019 report by the Centers for Disease Control and Prevention , 83% of Americans in their 60s and 70s took at least one prescribed medication in the previous 30 days and approximately one-third used five or more prescription drugs, most commonly to manage cholesterol, high blood pressure and diabetes. (businesswire.com)
  • The positive pressure non-hazardous drug sterile compounding cleanroom calculated air changes per hour (ACH) was 104, thus exceeding the minimum ACH requirements [USP 2019]. (cdc.gov)
  • The negative pressure hazardous drug sterile compounding cleanroom calculated ACH was 69, also exceeding the minimum ACH requirements [USP 2019]. (cdc.gov)
  • If the interaction triggers faster clearance of the drug from the body, then you may not be getting the appropriate therapeutic benefit. (fda.gov)
  • Reporting in The Journal of Clinical Investigation , Jeremy Nathans, Ph.D., Hugh Cahill, Ph.D., and Amir Rattner, Ph.D., state that changes in eye movements correctly indicated the therapeutic effect of antipsychotic drug treatment in a pharmacologic model of schizophrenia. (genengnews.com)
  • Antiretroviral therapy should never replace adopting and maintaining behaviors that guard against HIV exposure (e.g., sexual abstinence, sex only with an uninfected partner, consistent and correct condom use, abstinence from injecting-drug use, and consistent use of sterile equipment by those unable to cease injecting-drug use). (cdc.gov)
  • Sweeney was awarded Hamdan Award for Medical Research Excellence - Molecular Therapy in Drug Targeting (Pharmacogenomics) in 2008 by Hamdan Medical Award. (wikipedia.org)
  • In 2012, QDRL joined with the Food and Drug Administration (FDA), the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention's Office of Blood, Organ, and Other Tissue Safety, and other interested partners to evaluate the FDA's current blood donation policy regarding men who have sex with other men (MSM). (cdc.gov)
  • QDRL is evaluating the long form of the Blood Donor History Questionnaire (BDHQ), endorsed by AABB and used by the American Red Cross and many blood donation centers to help defer high-risk donors and help ensure the continued safety of the country's blood supply. (cdc.gov)
  • Evaluating drug targets through human loss-of-function genetic variation. (bvsalud.org)
  • If drugs are interacting, there are a few potential consequences. (fda.gov)
  • These user-friendly and disposable paper devices demonstrate the applicability of rapid on-site illicit drug detection, illustrating the application to wastewater-based epidemiology, which has the potential to inform government agencies regarding societal interventions. (cranfield.ac.uk)
  • The purpose of the site visit was to identify and evaluate hazardous drug engineering controls as well as to sample for potential surface contamination at the hospital. (cdc.gov)
  • The presence of potential surface contamination was evaluated with wipe samples. (cdc.gov)
  • A deep-learning algorithm was able to automatically identify binding sites on proteins that could be good targets for drug candidates, according to research. (scienceboard.net)
  • First, even essential genes , in which loss-of-function variants are not tolerated, can be highly successful as targets of inhibitory drugs . (bvsalud.org)
  • What is a drug-drug interaction? (fda.gov)
  • A drug-drug interaction occurs when the co-administration of two or more drugs alters any of these processes. (fda.gov)
  • Accordingly, FDA must evaluate numerous new PMTAs for e-cigarettes and other tobacco products, decide whether to allow their marketing and, when allowed, determine what product, labeling, and marketing requirements and restrictions to include in the permissive PMTA orders to ensure that the product's marketing will be AFPPH. (fdli.org)
  • To do that, the paper looks carefully at what applicable law says FDA must, may, and cannot do when evaluating applications and structuring new product orders, and then considers how FDA could most ethically exercise its legal powers and discretion in this context pursuant to the major applicable ethical perspectives of utilitarianism, bioethics, and public health ethics. (fdli.org)
  • To expand and refine its analysis, the paper then considers how FDA might most appropriately and ethically evaluate applications for PMTA or MRTP orders for e-cigarettes and what specific product, labeling, and marketing requirements and restrictions available research, experience, and analysis indicates FDA should include in any related permissive orders to make them both AFPPH and otherwise as ethically appropriate as possible. (fdli.org)
  • Preventive behaviors include sexual abstinence, sex only with an uninfected partner, consistent and correct condom use, abstinence from injecting-drug use, and consistent use of sterile equipment by those unable to cease injecting-drug use. (cdc.gov)
  • and from the anteroom to the positive pressure non-hazardous drug sterile compounding cleanroom was 0.03 inches of water. (cdc.gov)
  • If current drugs or other types of cancer treatment no longer benefit you, you may wish to explore joining a clinical trial. (cancercare.org)
  • December 28, 2022 - A clinical trial led by NCI has resulted in FDA approval of the immunotherapy drug atezolizumab (Tecentriq) to treat advanced alveolar soft part sarcoma. (nih.gov)
  • However, databases are unlikely to prove useful in improving antimicrobial use in the communities for a number of reasons: 1) most antimicrobial drug prescriptions in the community are written by primary care physicians, 2) most primary care physicians do not use these resources, and 3) industry-generated data are often used to highlight a particular antimicrobial drug. (cdc.gov)
  • Finally, in Chapter 3, we developed a semi-automated, case-crossover-based screening approach for identifying clinically relevant interacting drug pairs in electronic healthcare data. (harvard.edu)
  • Flagship machine learning platform for ADMET modeling with extended capabilities for data analysis, metabolism prediction, high-throughput pharmacokinetic simulation (HTPK), and AI-driven drug design. (simulations-plus.com)
  • These registries are mainly focused on one drug only and data is frequently incomplete. (biomedcentral.com)
  • Instead, pharmaceutical companies may be required to collect long-term data in a drug registry as part of their authorization. (biomedcentral.com)
  • Data from CDC (1, 2) (highlighted in a February 13, 2021 CDC/ external icon Infectious Diseases Society of America COVID-19 Clinical Call) and the Food and Drug Administration (3) suggest that there has been increasing use of systemic corticosteroids and antibiotics to treat outpatients with COVID-19. (cdc.gov)
  • The report came in the wake of an NAACP complaint filed over the summer after two City employees were sent for drug testing shortly after speaking publicly at a Second Ward meeting. (evanstonroundtable.com)
  • Taking interacting drugs together can potentially delay, decrease, or enhance absorption, affect a drug's pharmacology at the target, or influence drug metabolism or excretion. (fda.gov)
  • The effect of absorption on drug supersaturation was found to be dependent on the drug, and the tested level of supersaturation. (pion-inc.com)
  • Further studies are needed to evaluate the observed drug‐dependent effects of absorption on drug supersaturation. (pion-inc.com)
  • Their paper is titled "Preclinical assessment of CNS drug action using eye movements in mice. (genengnews.com)
  • [ 9-21-2015 ] The U.S. Food and Drug Administration (FDA) is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. (fda.gov)