Dose drugs investigational. Medical search. Frequent questions

A booster dose of Ebola vaccine is available for people at least 6 months after the single dose under an expanded access Investigational New Drug (IND) program. (cdc.gov)
Tecovirimat use under the expanded access Investigational New Drug protocol must be for patients who meet eligibility criteria and per the recommended dosing. (cdc.gov)

We continue to open additional clinical sites for our FTD program and expect to dose the first patient in mid-2022. (biospace.com)

Based on this molecular research, investigators chose to use the drug ibrutinib (formerly PCI-32765), a potent inhibitor of BTK, in their clinical trials. (nih.gov)
ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor that is being developed as a potential therapeutic option across a variety of T cell-mediated diseases. (wkrn.com)
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. (merck.com)
Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of. (lymphomainfo.net)
FTX-6058 is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development that was discovered using Fulcrum's proprietary discovery engine. (pharmamanufacturing.com)
[1] New findings advocating for long-term maintenance of sinus rhythm stem from the Stroke Prevention Oral Inhibitor in Atrial Fibrillation (SPORTIF) III trial that suggest that an investigational drug may be a better long-term maintenance option than standard warfarin therapy for AF because the investigational agent can be administered in the outpatient setting without frequent dose adjustments. (medscape.com)

In the current era of rapid marketing approval for promising new products in oncology, dose finding and optimization for small-molecule oncology drugs occurs throughout the development cycle and into the postmarketing setting. (aacrjournals.org)
Eloxx's lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. (yahoo.com)
Recently small-molecule oligonucleotide design has opened up new avenues to improve the treatment of drug-resistant viral infections, along with the development of COVID-19 medicines. (bvsalud.org)
In general, the recommended approach is similar to that for small molecule drugs. (bvsalud.org)

Neonatal dose: Under evaluation in Pediatric AIDS Clinical Trial Group protocol 332. (cdc.gov)
HOUSTON, July 11, 2023 (GLOBE NEWSWIRE) - Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) , a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, announces U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). (itbusinessnet.com)
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. (childrenshospital.org)
Yale University has begun a clinical trial of MN-166 (ibudilast), an asthma drug, to gauge its effectiveness in treating severe COVID-19 patients. (centerwatch.com)
STAMFORD, Conn., April 29, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. , (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced topline results from its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA™ (difelikefalin tablets) for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) patients. (biospace.com)
MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC ( NCT05652868 ). (businesswire.com)
Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualized investigational Antisense Oligonucleotide (ASO) drugs in a clinical trial and conducting clinical assessments of the safety and response during administration of the investigational ASO drug. (fda.gov)
People with cancer may take investigational drugs as part of a clinical trial. (medlineplus.gov)

The study enrolled 60 healthy subjects across 6 dosing cohorts ranging from 10 to 80 mg of total daily doses, with 8 active/2 placebo controlled per arm. (wkrn.com)
Further SAD and multiple ascending dose (MAD) testing is expected to be conducted following the completion of the planned dose cohorts in the SAD study and discussion with the FDA. (yahoo.com)

Subjects in this study will also receive the immunotherapy drug Atezolizumab during and after radiation therapy. (froedtert.com)
This phase 1 study was created to determine the highest dose of the investigational immunotherapy drug CDX-1140 that can be given safely to patients. (curetoday.com)

Pediatric usual dose: In combination with other antiretrovirals: 90 mg per m2 of body surface area every 12 hours. (cdc.gov)
Pediatric dose: 4 mg per kg of body weight twice daily. (cdc.gov)
Pediatric dose: 1 mg per kg of body weight every 12 hours (up to weight of 30 kg). (cdc.gov)
This research study is evaluating the safety, tolerability and preliminary efficacy of the drugs marizomib and panobinostat in pediatric patients with diffuse intrinsic pontine glioma (DIPG). (childrenshospital.org)
Vyluma announces FDA acceptance of New Drug Application for NVK002, its novel investigational treatment for pediatric myopia. (empr.com)

Both atacicept doses were associated with reductions in total Ig levels and anti-dsDNA antibodies, and increases in C3 and C4 levels. (bmj.com)
Panels of serum samples from individuals with differing Smallpox-vaccine doses and those with prior MPXV infection were tested on these assays, where we observed that one dose of Smallpox vaccination induces a low number of antibodies to a limited number of MPXV antigens but increasing with further vaccination doses. (cdc.gov)

Drug shortages threaten patient safety. (ahrq.gov)
Innate Pharma has dosed its first COVID-19 patient in a phase 2 trial of its investigational cancer drug avdoralimab. (centerwatch.com)
10%) patient population (p=0.036, All doses vs placebo) which was evident at week 1 and sustained through the treatment period. (biospace.com)
10%) patient population with 32% of KORSUVA-treated patients achieving a ≥4 point reduction in NRS at Week 12 versus 19% in the placebo group (p=0.033, All doses vs placebo). (biospace.com)
As previously reported, one patient in the highest dose cohort had a treatment-related serious adverse event of hypotension (grade 3) and fever (grade 2), with symptoms of headache and tachycardia, which occurred six hours post-infusion with giroctocogene fitelparvovec and resolved approximately 12 hours post-infusion. (pharmiweb.com)
A few days before these modified T cells are infused back into the patient, the patients are given a low-dose chemotherapy (lymphodepletion) regimen to help increase the effectiveness of the therapy. (medscape.com)
We remain focused on execution across our ongoing clinical programs and are excited to have dosed additional patients in our Imagine-1 trial for GM1 gangliosidosis as well as the first patient in our GALax-C trial for infantile Krabbe disease," said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. (biospace.com)
Single-subject clinical trials-also called 'N of 1' trials-focus on evaluating investigational drug products developed for an individual patient. (fda.gov)

The first cohort of patients has already been dosed in a separate phase 1/2 trial being conducted in Germany in collaboration with BioNTech. (centerwatch.com)
At 104 weeks, the five patients in the highest dose 3e13 vg/kg cohort had mean factor VIII (FVIII) activity of 25.4% via chromogenic clotting assay. (pharmiweb.com)
No participants in the highest dose cohort have resumed prophylaxis. (pharmiweb.com)
Among the five patients in the highest dose cohort, four received corticosteroids for liver enzyme (ALT/AST) elevations. (pharmiweb.com)
PGEN ), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announces positive Phase 1 dose escalation and expansion cohort data as of the January 12, 2023 cutoff for the investigational, potential first-in-class PRGN-2012 off-the-shelf (OTS) AdenoVerse™ immunotherapy in patients with recurrent respiratory papillomatosis (RRP). (pipelinereview.com)

According to trial results, patients on a five-day regimen of the drug saw clinical improvements similar to those on the 10-day treatment schedule, the company said. (centerwatch.com)

Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics. (itbusinessnet.com)
IDS staff provide expertise in study preparation, pharmacokinetics, drug interactions, dosing and drug compounding. (roswellpark.org)

Oral KORSUVA was generally well-tolerated across all doses. (biospace.com)

Note: may need higher dose in patients with central nervous system disease. (cdc.gov)
Plasma from vaccinated persons is used to produce horse (challenged with sublethal dose of Corynebacterium Anthrasil (Cangene Corporation, Winnipeg, Manitoba, diphtheriae ) to develop equine diphtheria antitoxin (DAT), Canada), a fully human polyclonal antianthrax intrave- which seemed to confer passive immunity to patients with nous immunoglobulin (IVIG) licensed in the United States. (cdc.gov)
In this placebo-controlled, double-blind, multicentre, multinational dose-guiding study we assessed 1883 patients who had had recent ST-elevation or non-ST-elevation myocardial infarction. (nih.gov)
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. (wkrn.com)
Patients must have received their last dose of known myelosuppressive chemotherapy at least 21 days prior to enrollment (42 days if prior nitrosourea). (childrenshospital.org)
Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to drug initiation. (mayo.edu)
Patients must have discontinued enzalutamide or abiraterone/prednisolone ≥4 weeks prior to study drug initiation. (mayo.edu)
FDA clearance to begin our planned single ascending dose trial is an important milestone towards providing a potential treatment option for patients with RDEB and JEB," said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. (yahoo.com)
Similarly, the National Institutes of Health reported that data from its trial of remdesivir shows the drug "has a clear-cut significant positive effect in diminishing the time to recovery" for COVID-19 patients. (centerwatch.com)
These latest results further suggest the potential of this investigational therapy to bring transformational benefit to eligible patients living with severe hemophilia A, if confirmed in ongoing clinical trials," said Seng H. Cheng, Senior Vice President and Chief Scientific Officer, Pfizer Rare Disease. (pharmiweb.com)
Following the observation of FVIII levels greater than 150% in some treated patients, Pfizer voluntarily paused screening and dosing of additional patients in the trial to implement a protocol amendment to provide clinical management guidance for elevated FVIII levels. (pharmiweb.com)
In September of last year, researchers in Germany reported that five patients with refractory systemic lupus erythematosus (SLE) treated with CAR T-cell therapy all achieved drug-free remission. (medscape.com)
The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with. (lymphomainfo.net)
They enrolled 107 patients with hypertension into the study, with patients in part A receiving a single ascending dose of zilebesiran or placebo, and patients in parts B and E receiving zilebesiran alongside a certain diet or another hypertension treatment, respectively. (genomeweb.com)
Patients should receive a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks. (nih.gov)
The FDA is hopeful these draft guidances, once finalized, will help promising drugs reach patients in a timely manner. (fda.gov)
We are optimistic that the development of these individualized drug products may continue to change the landscape for treating rare diseases, and the FDA is committed to providing resources and guidance to those advancing these technologies to treat patients in need. (fda.gov)
Some patients will receive this vaccine in increasingly larger doses to determine the highest dose, while others will also receive Tecentriq in addition to this vaccine. (curetoday.com)
While photodynamic therapy can be used to treat cancer by applying laser light to a tumor after a drug is injected into the body, its side effects can often be painful and troublesome to patients. (curetoday.com)
This trial will specifically look at the different doses of laser light to be used in therapy for patients with persistent kidney and ureter cancers. (curetoday.com)
The purpose of this study is to find the highest dose of the investigational drug AL102 that can be given safely in patients with desmoid tumors that continue to grow. (mskcc.org)
In the short-term, the use of low-molecular weight heparin (LMWH) for cardioversion of patients hospitalized with AF significantly reduces hospital length of stay (LOS), according to a team at Northwestern University (Evanston, Illinois), despite the fact that the drug is not approved for this indication by the United States Food and Drug Administration (FDA). (medscape.com)

The 2017 American Academy of Sleep Medicine recommendations focused on treatment with drugs were similar. (wikipedia.org)
A 2010 review of treatments for chronic hives found that doxepin had been superseded by better drugs but was still sometimes useful as a second-line treatment. (wikipedia.org)
Misadministration of IV insulin associated with dose measurement and hyperkalemia treatment. (ahrq.gov)
Marizomib has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. (childrenshospital.org)
Panobinostat has not approved by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma but it has been approved for other uses. (childrenshospital.org)
Northwell Health's Feinstein Institutes for Medical Research is researching famotidine, the active ingredient in the heartburn drug Pepcid, as a potential COVID-19 treatment. (centerwatch.com)
Although no dose group met this endpoint, a statistically significant improvement from baseline was evident as early as week 1 for the 1 mg dose group which was sustained through 75% of the treatment period. (biospace.com)
Treatment with a new class of drugs, called senolytics, in donors improved the physical fitness of the recipients, a new study has shown. (medicaldaily.com)
This treatment is investigational, meaning it has not been approved by the FDA for the treatment of your cancer. (froedtert.com)
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for NVK002 (low dose atropine 0.01%) for the treatment of children with myopia. (empr.com)
In xenograft mouse models, the treatment was well tolerated in myeloma tumor-bearing mice and significantly reduced tumor growth and IRF4 mRNA expression in tumor tissues in a dose-dependent manner after two to six weeks of treatments. (scienceboard.net)
The drug has received FDA Fast Track and Orphan Drug designations for SCD treatment. (pharmamanufacturing.com)
Treatment is generally supportive and potentially with antiviral drugs. (msdmanuals.com)
There is a difference between an unproven treatment and investigational drugs. (medlineplus.gov)

Novartis has also provided almost 30,000 vaccine doses to Princeton University and the University of California Santa Barbara (UCSB) after a meningitis B outbreak. (pharmaceuticalonline.com)
Administration of additional vaccine doses is currently not recommended for any population and may not be legally covered if administered. (cdc.gov)

In the paper, Juliette Hordeaux, D.V.M., Ph.D., D.E.C.V.P., and colleagues from University of Pennsylvania's Gene Therapy Program (GTP), report marked improvements in both disease progression and key biomarkers in large and small animal models of Krabbe disease following a single administration of PBKR03, with no observed dose-limiting toxicities. (biospace.com)

Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of chemotherapy. (uclahealth.org)
Halving the usual dose of radiation and combining it with chemotherapy can produce high survival rates in people with early-stage Hodgkin's lymphoma. (lymphomainfo.net)
Because immunotherapies like Opdivo and Yervoy have been shown to help the body fight cancer using its own immune system, the trial, which is being conducted in more than 600 locations, aims to determine whether the addition of a chemotherapy drug, such as Cabometyx, can improve outcomes. (curetoday.com)

Given the recent history of approvals based on the results of early-phase trials driven by extraordinary efficacy data, the incentive for conducting rigorous dose-finding trials may not occur prior to marketing approval. (aacrjournals.org)
Furthermore, the unknown efficacy in light of frequent dose reductions in the postmarket setting raises the question of whether efficacy reported in early-phase trials is accurate when applied to a real-world population. (aacrjournals.org)
The primary efficacy outcome was the dose response of ximelagatran by comparison with placebo for the occurrence of all-cause death, non-fatal myocardial infarction, and severe recurrent ischaemia. (nih.gov)
Mythic Therapeutics is a product-platform company developing a pipeline of antibody-drug conjugates (ADCs) designed to exhibit unparalleled therapeutic index and efficacy. (businesswire.com)

With the hold now lifted, Fulcrum expressed optimism about the potential of FTX-6058 based on phase 1b trial data, which showed increased levels of HbF with each dose escalation. (pharmamanufacturing.com)

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral. (lymphomainfo.net)
The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent. (lymphomainfo.net)
Bexsero was supplied to the universities under an FDA Investigational New Drug designation. (pharmaceuticalonline.com)

The company announced that it will supply second doses of the vaccines in the fall of this year as part of the campaign. (pharmaceuticalonline.com)
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. (fda.gov)

Many trials that support a regulatory application have high rates of dose reductions and discontinuations, which may result in postmarketing requirements (PMR) to study alternate doses or dosing schedules. (aacrjournals.org)
However, the increasing need for the development of combination therapy due to resistance to monotherapy and poor long-term tolerance of approved dosing regimens, as evidenced by the frequency of dose reductions and/or interruptions ( Table 1 ) in trials supporting marketing applications ( 1-4 ), underscores the need for a more efficient process of dose selection in the early stages of clinical development. (aacrjournals.org)
Once finalized, this guidance will detail important clinical and production considerations to support applications for these types of clinical trials and drug development programs. (fda.gov)
Women are more likely than men to suffer adverse side effects of medications because drug dosages have historically been based on clinical trials conducted on men, suggests new research. (sciencedaily.com)
When it comes to prescribing drugs, a one-size-fits-all approach, based on male-dominated clinical trials, is not working, and women are getting the short end of the stick," said study lead author Irving Zucker, a professor emeritus of psychology and of integrative biology at UC Berkeley. (sciencedaily.com)
For decades, women were excluded from clinical drug trials based, in part, on unfounded concerns that female hormone fluctuations render women difficult to study, Zucker said. (sciencedaily.com)
While the inclusion of females in drug trials has increased in recent years, many of these newer studies still fail to analyze the data for sex differences, Zucker said. (sciencedaily.com)
Investigational trials of anticancer drugs: establishing safeguards for experimentation. (cdc.gov)
Clinical trials are the last step before a drug can get approval from the FDA. (medlineplus.gov)

Pfizer and BioNTech advanced Comirnaty from research to product, gaining authorization in December 2020 and manufacturing 3 billion doses by the end of 2021. (nature.com)
Within the Pfizer Biotherapeutics Pharmaceutical Sciences and Global Supply organizations, we initiated parallel development of four COVID-19 vaccine candidates involving four separate work streams for plasmids, mRNA and drug product, as well as analytics and production facility planning (for example, process scale-up and eventual validation) while simultaneously processing initial clinical supplies. (nature.com)
Subsequently, on November 3, 2021, the U.S. Food and Drug Administration (FDA) informed Pfizer that this trial has been placed on clinical hold while the protocol amendment and associated documents are reviewed. (pharmiweb.com)
The single-dose shot from Pfizer, known as Abrysvo, has already been approved by the Food and Drug Administration. (medicaldaily.com)

Kinase inhibitors particularly have been susceptible to this problem, and among the 31 approved drugs of this class, the approvals of eight have included such PMRs and/or commitments. (aacrjournals.org)
It is NOT recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine. (drugs.com)

For persons with sexual risk factors for mpox who have not been diagnosed with mpox during the ongoing outbreak or have not already received 2 doses of the vaccine, CDC asks that clinicians encourage vaccination. (cdc.gov)

Amy E. McKee, Office of Hematology and Oncology Products, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, White Oak, MD 20993. (aacrjournals.org)

Within 14 days after the index event we randomised the participants in the proportions 1/1/1/1/2 to oral ximelagatran at doses of 24 mg, 36 mg, 48 mg, or 60 mg twice daily, or placebo, respectively for 6 months. (nih.gov)
Based on the Independent Data Monitoring Committee's (IDMC) recommendation, the sample size for the 0.5mg dose and placebo groups was increased by approx. (biospace.com)
A statistically significant improvement was also achieved for the 0.5 mg dose (p=0.046, 0.5mg vs placebo). (biospace.com)
Three-year data showed that NVK002 at a dose of 0.01% achieved statistically significant and clinically meaningful differences compared with placebo for key outcome measures, including responder analysis, mean change from baseline in Spherical Equivalent Refraction, and mean change from baseline in axial length. (empr.com)

Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138. (wkrn.com)

A WHO smallpox vaccine emergency stockpile of 32.6 million doses is stored safely and securely in Switzerland. (who.int)

The draft guidance describes important clinical considerations for investigational new drug application (IND) submissions to support initial and continued administration, dosing and clinical monitoring of an individual who is eligible to receive an individualized investigational ASO drug. (fda.gov)

Although only a handful of cell and gene therapies are on the market, FDA officials predicted in 2019 that the agency will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year. (ajmc.com)

The loading dose of TROGARZO is administered as a diluted intravenous infusion (IV infusion). (nih.gov)

Researchers analyzed data from several thousand medical journal articles and found clear evidence of a drug dose gender gap for 86 different medications approved by the Federal Drug Administration (FDA), including antidepressants, cardiovascular and anti-seizure drugs and analgesics, among others. (sciencedaily.com)

GAITHERSBURG, Md. and BASEL, Switzerland, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it entered into an agreement with Lonza for the manufacturing of AdCOVID ™ , Altimmune's next-generation, single-dose intranasal vaccine candidate for COVID-19. (yahoo.com)

2 U.S. Food and Drug Administration, Silver Spring, Maryland. (aacrjournals.org)
Since then, two biotechnology companies - Cabaletta Bio in Philadelphia and Kyverna Therapeutics in Emeryville, California - have already been granted fast-track designations from the US Food and Drug Administration for CAR T-cell therapy for SLE and lupus nephritis . (medscape.com)
Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for. (lymphomainfo.net)
The U.S. Food and Drug Administration (FDA) awarded Breakthrough Status to the vaccine in April of this year. (pharmaceuticalonline.com)
That is why it is important to use cancer treatments that have been approved by the US Food and Drug Administration (FDA). (medlineplus.gov)

I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved. (ajmc.com)

Booster dose eligibility is assessed on an individual basis. (cdc.gov)

Tecovirimat (Tpoxx), however, is an antiviral drug that has causes less severe disease. (cdc.gov)
Unusual (more severe): Peripheral neuropathy (dose related), electrolyte abnormalities, and hyperuricemia. (cdc.gov)

Uncontrolled but large stud- young volunteers who received a booster dose of the teta- ies of mortality rates from that time suggested effectiveness nus-diphtheria vaccine. (cdc.gov)
Hospital General Universitario donors who recently received a booster dose of vaccine. (cdc.gov)

They recommend dosage reductions for women for a wide range of drugs. (sciencedaily.com)

In addition, WHO acknowledges the specialized input from HIV experts Kel y Dooley, Diane Havlir and Gary Maartens, on concomitant use of bedaquiline and antiretroviral drugs. (bvsalud.org)

Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. (nih.gov)

The trial will evaluate the drug in treating acute respiratory distress syndrome and will be run with help from California-based MedicNova, the drug's developer. (centerwatch.com)
Moreover, until the early 1990s, women of childbearing age were kept out of drug trial studies due to medical and liability concerns about exposing pregnant women to drugs and risking damage to their fetuses -- as was the case in the 1950s and '60s with thalidomide, which caused limb birth defects in thousands of children worldwide. (sciencedaily.com)
CDX-1140 is being examined because other drugs like it have been shown to trigger a patient's immune system to fight against tumors, according to Memorial Sloan Kettering Cancer Center, where this trial is being conducted. (curetoday.com)

Dose modifications of TROGARZO are not required when administered with any other antiretroviral or any other treatments. (nih.gov)
These treatments come in all forms, from creams and salves to mega-doses of vitamins. (medlineplus.gov)

We recorded no serious clinically adverse outcomes judged related to the investigational drug. (nih.gov)

A potential source might be affinity-purified under an Investigational New Drug protocol ( 5 ). (cdc.gov)
Product-related issues make error potential enormous with investigational drugs. (ahrq.gov)
AdCOVID is a single-dose COVID-19 vaccine candidate that has the potential to be conveniently administered via an intranasal spray. (yahoo.com)
The potential of oligonucleotide therapeutics is undeniable as more than 15 drugs have been approved to treat various diseases in the liver, central nervous system (CNS), and muscles. (bvsalud.org)

CMS 30-minute rule for drug administration needs revision. (ahrq.gov)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (nih.gov)
Studies using higher dose, pharmacologic growth hormone (GH) administration have resulted in reduced visceral adiposity in this population, but are associated with increased insulin resistance and side effects [10-13]. (natap.org)
US Food & Drug Administration website. (medlineplus.gov)

a dose-dependent inhibition of both ITK and JAK3 exploratory pharmacodynamic (PD) biomarkers, with near maximal inhibition achieved at the 30 mg total daily dose. (wkrn.com)

Participants in these studies were given ibrutinib as a pill at a fixed dose of 560 milligrams daily until the disease progresses. (nih.gov)
The Investigational Drug Service (IDS) at Roswell Park Comprehensive Cancer Center is responsible for pharmacy support of clinical research studies. (roswellpark.org)
The clinical evaluation was conducted in the three phases common to investigational drug studies. (nih.gov)
Women in the studies analyzed by Zucker and University of Chicago psychologist Brian Prendergast were given the same drug dose as the men, yet had higher concentrations of the drug in their blood, and it took longer for the drug to be eliminated from their bodies. (sciencedaily.com)
It is hard to know if a product or drug really works just from reading claims or studies. (medlineplus.gov)

The FDA is also making available an additional draft guidance that provides recommendations regarding the chemistry, manufacturing and controls information that should be provided in an IND application for certain types of ASO drugs. (fda.gov)

Lack of standard dosing methods contributes to IV errors. (ahrq.gov)

Ebola vaccine is a live virus vaccine that is administered as a single dose by injection into a muscle. (cdc.gov)
TROGARZO is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. (nih.gov)
Injection: 200 mg/1.33 mL (150 mg/mL) in a single-dose vial. (nih.gov)

TROGARZO is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. (nih.gov)
Based on clinical experience with Altimmune's vaccine platform technology, AdCOVID is expected to provide durable immunity of up to a year or more following a single dose and to have an excellent tolerability and stability profile. (yahoo.com)

Access Investigational New Drug protocol, or EA-IND. (cdc.gov)

B-cell targeted therapies have been around since the early 2000s with drugs like rituximab , a monoclonal antibody medication that targets CD20, an antigen expressed on the surface of B cells. (medscape.com)

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