A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany).

Background: CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW).

Methods: Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.

Modulation of central corneal thickness by various riboflavin eyedrop compositions in porcine corneas.

Purpose: To evaluate the modulatory effect of various riboflavin 0.1% and 0.2% compositions on the central corneal thickness (CCT) in fresh porcine corneas.

Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation.

The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate compound. Gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus was used. Actual in vitro and in vivo data generated in CBZ bioequivalence studies were used for correlation purposes.

Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.

The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds.

Pharmacokinetics of the CYP 3A substrate simvastatin following administration of delayed versus immediate release oral dosage forms.

Purpose: The study was designed to evaluate the effect of delayed release (DR) on absorption and bioavailability of intestinally metabolized drugs after oral dosing, using the HMG-CoA reductase inhibitor simvastatin, a CYP3A substrate, as a model drug.

Materials And Methods: To target drug release and to assess regional gastrointestinal absorption of the CYP 3A substrate simvastatin from the distal parts of the intestine, delayed release film coated tableted oral dosage forms were developed. Simvastatin delayed release tablet, simvastatin immediate release capsule and simvastatin immediate release tablet Zocor were administered as single doses (20 mg) to fasting healthy volunteers in a crossover design.