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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
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Achieving successful bowel preparation with evening/morning split-dosing regimens of NER1006 versus trisulfate: post hoc analysis of a Phase 3 trial
July 25, 2017
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Authors: Michael Epstein, Pradeep Bekal Effective colonoscopy requires effective bowel preparation. For detection of polyps larger than 5mm, an ‘adequate’ segmental cleansing level has recently been defined as score 2 or higher on the Boston Bowel Preparation Scale (BBPS) [1]. The NOC
Continue Reading →Novel 1L Polyethylene Glycol (PEG)-Based Bowel Preparation NER1006 Achieves High Quality Bowel Cleansing with a Lower Volume than Standard 2L PEG + Ascorbate and Under 3L Total Fluid Volume Intake
July 25, 2017
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Authors: Michael Epstein, Lucy Clayton, Richard Ng Kwet Shing Introduction. Successful bowel cleansing is required for effective colonoscopy. Polyethylene glycol (PEG) –based bowel preparations are widely used for this, despite many still requiring high fluid volume intake. To avoid t
Continue Reading →Bowel preparation quality of NER1006 versus oral trisulfate solution as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial
July 25, 2017
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Authors: Michael Epstein, Pradeep Bekal; Richard Ng Kwet Shing Background: Effective colonoscopy requires successful bowel cleansing. Inadequate bowel cleansing may decrease diagnostic sensitivity, necessitate repeat procedures and potentially delay appropriate treatment. The increasi
Continue Reading →RANDOMIZED CONTROLLED TRIAL TO ASSESS THE EFFICACY & SAFETY OF CARAWAY OIL/L-MENTHOL PLUS USUAL CARE POLYPHARMACY VS. PLACEBO PLUS USUAL CARE POLYPHARMACY FOR FUNCTIONAL DYSPEPSIA
July 12, 2017
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William D. Chey, Brian E. Lacy, Brooks D. Cash, Michael Epstein, Syed M. Shah Background: There are no FDA-approved pharmaceutical agents for functional dyspepsia (FD). Previous trials suggested that a combination of caraway oil and peppermint oil (Lmenthol) may be effective for FD. T
Continue Reading →IN PATIENTS WITH IRRITABLE BOWEL SYNDROME-MIXED (IBS-M), A NOVEL PEPPERMINT OIL FORMULATION DESIGNED FOR SITE SPECIFIC TARGETING (PO-SST), IN THE SMALL INTESTINE, IMPROVES THE 8 SYMPTOMS THAT COMPRISE THE TOTAL IBS SYMPTOMS SCORE (TISS)
July 12, 2017
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Brooks D. Cash, Michael Epstein, Syed M. Shah Background: Among adult patients diagnosed with IBS, a significant proportion endorse a mixed bowel habit pattern. There is no approved therapy for IBS-M, and it remains an unmet medical need. In IBS, gut mucosal barrier dysfunction is lin
Continue Reading →PATIENT RESPONDER ANALYSIS FOR A TOTAL IBS SYMPTOM SCORE (TISS) AND ABDOMINAL PAIN WITH A NOVEL PEPPERMINT OIL SITE SPECIFIC TARGETING (PO-SST) FORMULATION FROM THE US-BASED IBSREST RANDOMIZED CONTROLLED TRIAL
July 11, 2017
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Brooks D. Cash, Michael Epstein, Syed M. Shah Background: There are high placebo response rates in IBS clinical trials. Recently, more restrictive outcome measures have been developed for IBS trials to distinguish between active treatment response and placebo response. However, a stri
Continue Reading →Pooled Safety and Tolerability Data From 4 Phase 3, Randomized, Active-Controlled Studies of a Low-Volume Sodium Picosulfate/Magnesium Citrate Bowel Preparation for Colonoscopy
July 11, 2017
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Bertiger, Gerald2 ; Epstein, Michael3 ; Lu, Liang4 ; Kitamura, Mikiya5 ; Bradesi, Sylvie1 ; Seifu, Yodit1 ; Brogadir, Stuart1 INSTITUTIONS (ALL): Ferring Pharmaceuticals Inc., Parsippany, NJ, United States. Hillmont G.I., Flourtown, PA, United States. Digestive Disorders Associates, A
Continue Reading →A CARAWAY OIL/MENTHOL COMBINATION IMPROVES FUNCTIONAL DYSPEPSIA (FD) SYMPTOMS WITHIN THE FIRST 24 HOURS: RESULTS OF A RANDOMIZED CONTROLLED TRIAL, WHICH ALLOWED USUAL FD TREATMENTS
July 10, 2017
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A CARAWAY OIL/MENTHOL COMBINATION IMPROVES FUNCTIONAL DYSPEPSIA (FD) SYMPTOMS WITHIN THE FIRST 24 HOURS: RESULTS OF A RANDOMIZED CONTROLLED TRIAL, WHICH ALLOWED USUAL FD TREATMENTS Brian E. Lacy, William D. Chey, Brooks D. Cash, Michael Epstein, Syed M. Shah Background: Functional dys
Continue Reading →EFFICACY OF CARAWAY OIL/L-MENTHOL PLUS USUAL CARE VS PLACEBO PLUS USUAL CARE, IN FUNCTIONAL DYSPEPSIA PATIENTS WITH POST-PRANDIAL DISTRESS (PDS) OR EPIGASTRIC PAIN (EPS) SYNDROMES: RESULTS FROM A US RCT
July 10, 2017
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EFFICACY OF CARAWAY OIL/L-MENTHOL PLUS USUAL CARE VS PLACEBO PLUS USUAL CARE, IN FUNCTIONAL DYSPEPSIA PATIENTS WITH POST-PRANDIAL DISTRESS (PDS) OR EPIGASTRIC PAIN (EPS) SYNDROMES: RESULTS FROM A US RCT William D. Chey, Brian E. Lacy, Brooks D. Cash, Michael Epstein, Syed M. Shah Back
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