Leading the Way in Pharmaceutical and Device Consulting
Clinical & Medical Consulting
Epstein Associates will guide you through the intensive processes concerning clinical research, medical device and technology, and regulatory affairs.
Business Development
Epstein Associates assists with the assessment of new therapeutic areas/opportunities, evaluation of partnership opportunities, evaluation of product opportunities, and the evaluation of other business development opportunities.
Pharmaceutical
Epstein Associates assists with Post Marketing Safety Surveillance, regulatory consulting, protocol writing, CRF creation, and research Clinical Development study design.
Regulatory Affairs
Epstein Associates will arrange a mock FDA panel meeting. Our services include the development of a comprehensive panel strategy for the sponsor including organizing a slide presentation, streamlining Q & A and creating a Post Panel Action Report.
Legal Consulting, Pharmaceutical Patent Consulting, Patent Infringement and Device Infringement
Epstein Associates, LLC
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News & Announcements
Scientific Publication: GEODE-II: Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Low-Dose Ribavirin QD in Patients with Genotype 1a Chronic Hepatitis C Virus Infection without Cirrhosis
November 07, 2016
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Objective: Evaluate the safety and efficacy of OBV/PTV/r + DSV with low-dose RBV (600 mg once daily) for 12 weeks in GT1a HCV-infected patients, naïve or experienced (with pegIFN/RBV), without cirrhosis and compare with the historical SVR12 rate for 3-DAA + full-dose, weight based RBV
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IBgard safe, well-tolerated in IBS patients
October 21, 2016
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Six-month data from a real-world surveillance study shows over-the-counter IBgard is safe and well-tolerated in patients with irritable bowel syndrome, according to a press release from the manufacturer.
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Patient Satisfaction with IBS Symptom Relief Using a Novel Peppermint Oil Delivery System in a Randomized Clinical Trial and in the General Population
October 21, 2016
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A recent randomized clinical trial (RCT) of a novel peppermint oil preparation (PO-SST) demonstrated significant relief of irritable bowel syndrome (IBS) symptoms versus placebo. In addition to efficacy, patient satisfaction and post-marketing utilization are also important to assess.
Continue Reading →INTERIM RESULTS OF REAL-WORLD DATA FROM OBSERVATIONAL STUDY DEMONSTRATE HIGH LEVELS OF PATIENT SATISFACTION AND RAPID IMPROVEMENT OF FUNCTIONAL DYSPEPSIA (PERSISTENT OR RECURRING INDIGESTION) WITH NEW NON-PRESCRIPTION FDgard®
October 17, 2016
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Functional Dyspepsia (FD), known for its symptoms of persistent or recurring indigestion, impacts an estimated 1 in 6 adults in the U.S. Rapid symptom improvement reported by patients taking FDgard® Patients reported high overall level of satisfaction and enhanced quality of life whil
Continue Reading →PROMINENT, PEER-REVIEWED MEDICAL JOURNAL PUBLISHES RESULTS OF A KEY STUDY DEMONSTRATING THE EFFECTIVENESS, SAFETY, AND TOLERABILITY OF THE NOVEL DELIVERY SYSTEM OF PEPPERMINT OIL IN IBgard®, A NEW MEDICAL FOOD FOR IRRITABLE BOWEL SYNDROME (IBS)
October 05, 2015
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IBgard® demonstrated to be an effective, safe and well tolerated option to address unmet need for patients with IBS Rapid and symptomatic improvement of the most bothersome gastrointestinal symptoms at 24 hours and at four weeks First clinical trial to use patented Site Specific Targe
Continue Reading →New formulation of IBgard improves IBS symptoms
September 21, 2015
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IBgard, a new, more purified formulation of IBgard, an over-the-counter medical food containing a blend of L-menthol and peppermint oil, improved IBS symptoms within 4 weeks, according to data presented at the AGA’s 2015 James W. Freston Conference in Chicago. “This single-arm 2015 IB
Continue Reading →Twenty-Four-Hour Results From a Placebo-Controlled Trial to Evaluate a Novel Peppermint Oil Delivery System, Targeting Release in the Small Intestine. Results From the U.S.-Based, 4-Week, Randomized, Placebo-Controlled, Multi-Centered IBSREST Trial
August 17, 2015
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For IBS patients, current formulations of mint oil may cause heartburn, nausea, and anal burning because they tend to “dose-dump” in the stomach or pass all the way through the colon. However, a novel delivery system (IBgard, IM HealthScience LLC) allows solid beads of highly purified
Continue Reading →Novel Peppermint-Oil Delivery System Reduces Symptoms of Irritable Bowel Syndrome
July 24, 2015
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By Walter Alexander WASHINGTON, D.C. — May 20, 2015 — A novel delivery system that releases peppermint oil into the small intestine demonstrated reduction in the symptoms of irritable bowel syndrome (IBS) when compared with placebo, according to 24-hour results of Irritabl
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Over-the-counter IBgard improves IBS symptoms
July 24, 2015
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WASHINGTON — Michael Epstein, MD, senior medical advisor for IMHealthScience, discusses his presentation on IBgard, a new medical food product for the treatment of diarrhea-predominant and mixed-symptom irritable bowel syndrome. According to a press release, IBgard works by delivering
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