Analytical Quality by Design, Life Cycle Management, and Method Control.

Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control manufacturing inputs and outputs. These analytical methods should continuously provide quality data to support decisions while managing the remaining of risk and uncertainty. Analytical quality by design (AQbD) can provide a systematic framework to achieve a continuously validated, robust assay as well as life cycle management.

Nontransvenous Cardiovascular Implantable Electronic Device Technology-A Review for the Anesthesiologist.

There has been a recent shift in bradycardia pacing and defibrillation therapy to leadless pacemakers and extrathoracic cardioverter-defibrillator technology due to complications associated with transvenous devices. These innovations have implications for anesthesia care, as these novel devices have design and functionality features different from transvenous devices. Current perioperative guidelines do not address management of leadless pacemakers and the subcutaneous implantable cardioverter-defibrillator, although implantation rates are increasing globally.

The Year in Electrophysiology: Selected Highlights From 2020.

This article is the third in an annual series for the Journal of Cardiothoracic and Vascular Anesthesia. The authors thank the Editor-in-Chief Dr. Kaplan, the Associate Editor-in-Chief Dr.

Lactobacillus and bifidobacteria combinations: a strategy to reduce hospital-acquired Clostridium difficile diarrhea incidence and mortality.

Incidence and virulence of Clostridium difficile-associated disease (CDAD) is increasing, particularly in institutional settings. Morbidity, mortality, and costs associated with this condition are high. Broad-spectrum antibiotics have long been recognized as the primary risk factor for CDAD due to disruption of protective normal gastrointestinal flora.

N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet.

Significant degradation of the amine-based smoking cessation drug varenicline tartrate in an early development phase osmotic, controlled-release (CR) formulation yields predominantly two products: N-methylvarenicline (NMV) and N-formylvarenicline (NFV). NMV is produced by reaction of the amine moiety with both formaldehyde and formic acid in an Eschweiler-Clarke reaction, while NFV is formed by reaction of formic acid alone with varenicline. This represents the first report of these reactions occurring on storage of solid pharmaceutical formulations.

Improving the content uniformity of a low-dose tablet formulation through roller compaction optimization.

In this investigation, the potency distribution of a low-dose drug in a granulation was optimized through a two-part study using statistically designed experiments. The purpose of this investigation was to minimize the segregation potential by improving content uniformity across the granule particle size distribution, thereby improving content uniformity in the tablet. Initial operating parameters on the Gerteis 3-W-Polygran 250/100/3 Roller Compactor resulted in a U-shaped potency function (potency vs.

A case-control comparison of the clinical characteristics of glaucoma and ocular hypertensive patients with and without the myocilin Gln368Stop mutation.

Purpose: To determine whether primary open-angle glaucoma (POAG) and ocular hypertensive (OHT) patients who harbor the myocilin Gln368Stop mutation differ in phenotype or clinical course from patients without the mutation.

Design: Case-control study.

Methods: A retrospective case-control study compared all known POAG patients (n = 18) and OHT patients (n = 4) harboring the Gln368Stop mutation evaluated by the University of Iowa Glaucoma Service with control patients from the same population.

Total joint replacement: baseline benchmark data for interdisciplinary outcomes management.

Purpose: The purpose of this review was to define and describe 2 years of adverse outcome variances for elective primary or revision of major total joint replacement in terms of baseline benchmark data.

Design: Descriptive variance.

Methods: Retrospective review of patients with greater than 4 days in acute care after total joint replacement, patients with unexpected comorbidities that required medical subspecialist management, patients who were transferred to a higher level of care, and patients who did not survive postoperatively.

Progressive axial myopia in a juvenile patient with traumatic glaucoma.

Purpose: To report a case of progressive axial myopia associated with traumatic glaucoma in a juvenile patient with no systemic disease.

Design: Interventional case report.

Methods: In a 15-year-old male, serial ocular examinations, including manifest refraction, tonometry, and axial eye length measurement, were performed over a 6-year period, beginning with blunt trauma, right eye, followed by a series of surgical procedures for traumatic cataract and glaucoma.

Trabeculectomy for traumatic hyphema with increased intraocular pressure.

We reviewed the medical records of 11 consecutive patients who underwent trabeculectomy with anterior chamber washout and peripheral iridectomy as the primary surgical treatment for traumatic hyphema that was unresponsive to medical management. The mean intraocular pressure before surgery was 48 mm Hg. In ten of the patients the intraocular pressure was lowered to 21 mm Hg or lower after surgery and remained below that level up to the most recent follow-up visit, which ranged from eight to 97 months.