Product Information: Rifaximin
... C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients wh ...
... C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients wh ...
Fuzeon (enfuvirtide)
... of 24 weeks duration. Subjects enrolled were treatmentexperienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naive patients. There are no results from controlled trials evaluating the effect of FUZEON on clinical progression of HIV-1. Description of Clinical ...
... of 24 weeks duration. Subjects enrolled were treatmentexperienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naive patients. There are no results from controlled trials evaluating the effect of FUZEON on clinical progression of HIV-1. Description of Clinical ...
Inflammatory Bowel Disease
... Clinical Scenario 29 year old female, one month history of loose watery stools, increasing in frequency to 12 time per day now. Occasionally stools have blood and slime mixed in with them. Cramping left iliac fossa pain. Feels unwell and lethargic. On examination, febrile at 38.2. Has a soft abdome ...
... Clinical Scenario 29 year old female, one month history of loose watery stools, increasing in frequency to 12 time per day now. Occasionally stools have blood and slime mixed in with them. Cramping left iliac fossa pain. Feels unwell and lethargic. On examination, febrile at 38.2. Has a soft abdome ...
Targeting the androgen receptor in the
... Group performance status, and time to psa progression14. No important new safety signals were seen. The independent data monitoring committee unanimously recommended unblinding the study and allowing crossover of patients to the treatment group, which approximately 25% of the patients did. Given tha ...
... Group performance status, and time to psa progression14. No important new safety signals were seen. The independent data monitoring committee unanimously recommended unblinding the study and allowing crossover of patients to the treatment group, which approximately 25% of the patients did. Given tha ...
How is “safety” - Global Campaign for Microbicides
... increasing the spectrum of STI activity reducing the required concentration of expensive or potentially toxic agents ...
... increasing the spectrum of STI activity reducing the required concentration of expensive or potentially toxic agents ...
Medicines Management Programme
... ranked and weighted by experts, with urgency episodes per 24 hours considered the most important outcome, and nocturia the least important. Individual outcomes are not discussed in detail in this evaluation, though in general, higher doses of antimuscarinics resulted in greater mean reductions in ur ...
... ranked and weighted by experts, with urgency episodes per 24 hours considered the most important outcome, and nocturia the least important. Individual outcomes are not discussed in detail in this evaluation, though in general, higher doses of antimuscarinics resulted in greater mean reductions in ur ...
ICH M3 (R2): Non-Clinical Safety Studies for the Conduct of Human
... The development of a pharmaceutical is a stepwise process involving an evaluation of both the animal and human safety information. The goals of the nonclinical safety evaluation generally include a characterisation of toxic effects with respect to target organs, dose dependence, relationship to expo ...
... The development of a pharmaceutical is a stepwise process involving an evaluation of both the animal and human safety information. The goals of the nonclinical safety evaluation generally include a characterisation of toxic effects with respect to target organs, dose dependence, relationship to expo ...
Phase 2 Trial of an Alpha-7 Nicotinic Receptor
... Two phase 1 studies of TC-5619 in healthy male volunteers showed that single doses of TC-5619 were well tolerated up to 406mg (limited by orthostatic hypotension) and that multiple doses of 204mg were well tolerated (Targacept, data on file). An exploratory phase 2 study of TC-5619 evaluated doses o ...
... Two phase 1 studies of TC-5619 in healthy male volunteers showed that single doses of TC-5619 were well tolerated up to 406mg (limited by orthostatic hypotension) and that multiple doses of 204mg were well tolerated (Targacept, data on file). An exploratory phase 2 study of TC-5619 evaluated doses o ...
A Focus on Clinical Trials
... The instrument should be widely accepted as a measurement of drug outcomes in that specific patient group and condition. As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guid ...
... The instrument should be widely accepted as a measurement of drug outcomes in that specific patient group and condition. As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guid ...
Guidance for Industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment
... pharmacodynamic (PD) or clinical efficacy endpoint that is consistent with the expected benefit to be derived from the drug. The dose or doses selected for phase 3 studies should be based on benefit to risk assessment. If more than one dose is ultimately intended to be marketed, the clinical program ...
... pharmacodynamic (PD) or clinical efficacy endpoint that is consistent with the expected benefit to be derived from the drug. The dose or doses selected for phase 3 studies should be based on benefit to risk assessment. If more than one dose is ultimately intended to be marketed, the clinical program ...
Guidance for Industry Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment
... The guidance for industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PRO guidance), published in December 2009, defines treatment benefit as an improvement in how a patient survives, feels, or functions demonstrated by either an effectiveness or ...
... The guidance for industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PRO guidance), published in December 2009, defines treatment benefit as an improvement in how a patient survives, feels, or functions demonstrated by either an effectiveness or ...
1 Class Update: Calcium Channel Blockers (dihydropyridine and
... There is insufficient evidence comparing relative efficacy and safety of CCBs with each other. Current guidelines continue to recommend CCBs as a first‐line treatment option for hypertension.2‐4 There is insufficient evidence comparing a fixed‐dose combination product containing a CCB with the res ...
... There is insufficient evidence comparing relative efficacy and safety of CCBs with each other. Current guidelines continue to recommend CCBs as a first‐line treatment option for hypertension.2‐4 There is insufficient evidence comparing a fixed‐dose combination product containing a CCB with the res ...
SENIOR: Solifenacin (VESICARE) vs Oxybutynin
... At first glance this trial appears to support the use of solifenacin over oxybutynin because of their differing effects on cognition in elderly people with MCI. However, this is somewhat misleading as there was no difference in the primary end‐point studied. There is some potential for differences ...
... At first glance this trial appears to support the use of solifenacin over oxybutynin because of their differing effects on cognition in elderly people with MCI. However, this is somewhat misleading as there was no difference in the primary end‐point studied. There is some potential for differences ...
Bleeding and Blood Transfusion Issues Among Patients with Acute
... • Occurred early and were generally asymptomatic • All resolved even when treatment was continued • No Hy’s Law cases ...
... • Occurred early and were generally asymptomatic • All resolved even when treatment was continued • No Hy’s Law cases ...
NIAID Protocol Template Extramural Guidance, V. 2.0 (Extra), July
... PURPOSE of a Protocol: A protocol is where the investigators clarify and document their plan for all aspects of the study. It provides a guide for the research team to reference and follow over time and ensures that the IRB approved version of the study is implemented. When the study is complete, th ...
... PURPOSE of a Protocol: A protocol is where the investigators clarify and document their plan for all aspects of the study. It provides a guide for the research team to reference and follow over time and ensures that the IRB approved version of the study is implemented. When the study is complete, th ...
Paper - Primary Care Commissioning
... England spends more public money on orthodontic services than any other country in the world. There are currently around 25,000 NHS orthodontic patients per year treated in hospitals and around 130,000 in primary care. Primary care services are provided mostly by independent orthodontic practices. L ...
... England spends more public money on orthodontic services than any other country in the world. There are currently around 25,000 NHS orthodontic patients per year treated in hospitals and around 130,000 in primary care. Primary care services are provided mostly by independent orthodontic practices. L ...
Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing
... In the Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH) all regulate products to treat cutaneous wounds. This guidance contains recommendations ap ...
... In the Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH) all regulate products to treat cutaneous wounds. This guidance contains recommendations ap ...
Guideline on Clinical follow-up gene therapy
... administration of an authorised medicinal product. Routine pharmacovigilance apply for all authorised medicinal products. Besides, requirements for additional pharmacovigilance activities should be proportionate to the identified balance risk / benefit of the product. If later, new data become avail ...
... administration of an authorised medicinal product. Routine pharmacovigilance apply for all authorised medicinal products. Besides, requirements for additional pharmacovigilance activities should be proportionate to the identified balance risk / benefit of the product. If later, new data become avail ...
J.P. MORGAN 34TH ANNUAL HEALTHCARE CONFERENCE
... market potential of our product candidates, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly filings and annual reports. Forward-looking stat ...
... market potential of our product candidates, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly filings and annual reports. Forward-looking stat ...
AusPAR Attachment 2. Extract from the Clinical Evaluation Report
... VINCI) and the two pivotal Phase III studies (VISTA DME and VIVID DME). Clinical outcomes from these trials (particularly visual outcomes) are considered in the section on efficacy. Table 3 shows the studies relating to each pharmacodynamic topic and the location of each study summary. ...
... VINCI) and the two pivotal Phase III studies (VISTA DME and VIVID DME). Clinical outcomes from these trials (particularly visual outcomes) are considered in the section on efficacy. Table 3 shows the studies relating to each pharmacodynamic topic and the location of each study summary. ...
Kitov Pharmaceuticals
... securities laws. These forward looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not guar ...
... securities laws. These forward looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not guar ...
Pycnogenol Monograph - American Botanical Council
... reports of AEs despite millions of Pycnogenol doses sold. There were 3 cases of urticaria, 1 case of headache, 1 case of nausea, and 1 case of eczema and diarrhea. According to the manufacturer, urticaria is a rare allergic reaction that could be due to the color component of the tablet. There have ...
... reports of AEs despite millions of Pycnogenol doses sold. There were 3 cases of urticaria, 1 case of headache, 1 case of nausea, and 1 case of eczema and diarrhea. According to the manufacturer, urticaria is a rare allergic reaction that could be due to the color component of the tablet. There have ...
PDF - Molecular and Cellular Therapies
... Discharge (e) and Discomfort (f). Baseline is always defined as 0 for each arm. Days 1–14 are self-reported, End visit is evaluated by the physician, and Follow Up (FU) data is collected over the phone. PP110 Gel is always shown in red, PP110 Wipes in black and Preparation-H® in blue ...
... Discharge (e) and Discomfort (f). Baseline is always defined as 0 for each arm. Days 1–14 are self-reported, End visit is evaluated by the physician, and Follow Up (FU) data is collected over the phone. PP110 Gel is always shown in red, PP110 Wipes in black and Preparation-H® in blue ...
Patients - CRUK Clinical Trials Unit, Glasgow
... Radiotherapy Quality Assurance requires to be approved by the RTQA group as part of site initiation/set-up. ...
... Radiotherapy Quality Assurance requires to be approved by the RTQA group as part of site initiation/set-up. ...