Association of Standardized Radiology Reporting and Management of Abdominal CT and MRI With Diagnosis of Pancreatic Cancer.

Background & Aims: Follow-up of abdominal computed tomography (CT) and magnetic resonance imaging (MRI) findings suspicious for pancreatic cancer may be delayed if documentation is unclear. We evaluated whether standardized reporting and follow-up of imaging results reduced time to diagnosis of pancreatic cancer.

Methods: We used a quasi-experimental stepped-wedge cluster design to evaluate the effectiveness of newly implemented radiology reporting system.

Implementation of LI-RADS into a radiological practice.

Since its introduction in 2011, Liver Imaging Reporting and Data System (LI-RADS) has become an increasingly utilized method for radiologists to categorize lesions for hepatocellular carcinoma (HCC) in patients at risk (American College of Radiology, www.acr.org/quality-safety/resources/lirads 2016).

Ultrasound Monitoring of Extant Adnexal Masses in the Era of Type 1 and Type 2 Ovarian Cancers: Lessons Learned From Ovarian Cancer Screening Trials.

Women that are positive for an ovarian abnormality in a clinical setting can have either a malignancy or a benign tumor with probability favoring the benign alternative. Accelerating the abnormality to surgery will result in a high number of unnecessary procedures that will place cost burdens on the individual and the health delivery system. Surveillance using serial ultrasonography is a reasonable alternative that can be used to discover if changes in the ovarian abnormality will occur that favor either a malignant or benign interpretation.

Trauma in pregnant women: assessing detection of post-traumatic placental abruption on contrast-enhanced CT versus ultrasound.

Objectives: To evaluate detection of post-traumatic placental abruption with contrast-enhanced CT (CECT) and comparison with Ultrasound (US).

Methods: Picture Archive and Date System database at a level-1 trauma center was retrospectively reviewed using keywords pregnancy, trauma, and/or placental abruption over 10 years. CT was compared to US, if performed within 24 h.

Ultrasound follow up of an adnexal mass has the potential to save lives.

Ovarian cancer is among the most dreaded cancers since it is often found at a late stage where the opportunity for extended survival is poor. Ultrasound has been utilized in several ovarian cancer screening trials in asymptomatic women in order to detect ovarian cancer at early stages where survival rates are high. Efforts to improve screening for ovarian cancer are ongoing.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science.

A comparison of image contrast with (64)Cu-labeled long circulating liposomes and (18)F-FDG in a murine model of mammary carcinoma.

Conjugation of the (64)Cu PET radioisotope (t(1/2) = 12.7 hours) to long circulating liposomes enables long term liposome tracking. To evaluate the potential clinical utility of this radiotracer in diagnosis and therapeutic guidance, we compare image contrast, tumor volume, and biodistribution of (64)Cu-liposomes to metrics obtained with the dominant clinical tracer, (18)F-FDG.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities.

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.

2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.

Imaging findings of rhinocerebral mucormycosis.

Background And Objectives: The purpose of this study was to describe common radiographic patterns that may be useful in predicting the diagnosis of rhinocerebral mucormycosis.

Methods: We retrospectively evaluated the imaging and clinical data of four males and one female, 3 to 72 years old, with rhinocerebral mucormycosis.

Results: All the patients presented with sinusitis and ophthalmological symptoms.

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.

This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies.

Value of the vertebrogram in predicting cement filling patterns with unipedicular percutaneous vertebroplasty.

Background: Unipedicular vertebroplasty can be successful in selected patients to decrease procedure time, sedation amounts, and cost.

Purpose: To evaluate the value of the antecedent unipedicular vertebrogram in predicting patterns of cement deposition to decide whether unipedicular vertebroplasty will be successful, or if a bipedicular vertebroplasty is needed.

Material And Methods: 75 fractured vertebral levels were injected by a unipedicle approach with iodinated contrast material (vertebrogram).

Colonoscopy findings in end-stage liver disease patients with incidental CT colonic wall thickening.

Objective: Colonic wall thickening may occur in patients with end-stage liver disease. This study was conducted to correlate colonoscopy with CT-detected colonic wall thickening in this group of patients to assess their radiologic and clinical relevance.

Conclusion: Our results suggest that CT findings of colonic wall thickening in end-stage liver disease should be considered benign, and colonoscopy is unnecessary for the evaluation of malignancy or colitis unless it is clinically indicated.

The utility of sonography for the triage of blunt abdominal trauma patients to exploratory laparotomy.

Objective: The purpose of this study was to assess the utility of focused abdominal sonography for trauma (FAST) in the triage of hypotensive and normotensive blunt abdominal trauma patients to exploratory laparotomy.

Materials And Methods: Data entered in a trauma registry database were retrospectively reviewed and were correlated with medical records, radiology reports, and surgical laparotomy reports. In the setting of blunt abdominal trauma, hypotensive patients were compared with normotensive patients who underwent FAST.

Pelvic free fluid: clinical importance for reproductive age women with blunt abdominal trauma.

Objective: To evaluate the importance of isolated pelvic free fluid (FF) detected by ultrasound examination in pregnant patients and in non-pregnant reproductive age women with blunt abdominal trauma (BAT).

Methods: Reproductive age women aged 10-50 years who presented with BAT and underwent focused abdominal sonography for trauma (FAST) from January 1995 to June 2002 at a Level 1 trauma center were included. Patients were assigned to four groups according to the location of FF detected by ultrasound (Group 1, no FF; Group 2, FF in pelvis; Group 3, FF in abdomen; Group 4, FF in abdomen and pelvis).

Blunt abdominal injury in the pregnant patient: detection with US.

Purpose: To determine the accuracy of ultrasonography (US) for the detection of blunt intraabdominal injury in pregnant patients and to compare differences between pregnant and nonpregnant patients of childbearing age.

Materials And Methods: A retrospective review of results of all consecutive emergency blunt trauma US examinations performed at a level I trauma center from January 1995 to June 2002 was conducted. Data on demographics, free fluid location, and patient outcome were collected.

Metered dose inhalers III: Metaproterenol sulphate; particle size distribution and dose uniformity.

Three American products and one Canadian product were examined for content uniformity and particle size distribution. The results showed that not all products performed equally well. Some of the products exhibited high sprays early in the canister lifetime and all products demonstrated loss of prime.

Metered-dose inhalers, I: Drug content and particle size distribution of beclomethasone dipropionate.

Four commercially available beclomethasone metered dose inhalers were analyzed for both spray content uniformity and particle size. The drug contents of primed and unprimed sprays collected at the beginning of the lifetime of the canister were not significantly different from those collected throughout the experiment. Particle size analysis of the four products using the Andersen Cascade Impactor Mark II showed that the distribution profiles were not identical.

Toxicodynamics and toxicokinetics of amikacin in the guinea pig cochlea.

An extensive overview of the relationship between cochlear toxicity and amikacin blood concentrations in the guinea pig is provided which should assist in the clinical application of this class of antibiotic. A data set previously used to relate the incidence of amikacin ototoxicity to dosing rates and blood concentrations was re-examined to assess the toxicodynamics of amikacin in terms of decibels of hearing loss across dosing rate, hearing frequency and time following drug exposure. Animals in this data set had received continuously i.