Urine biomarkers can predict prostate cancer and PI-RADS score prior to biopsy.

Prostate-Specific Antigen (PSA) based screening of prostate cancer (PCa) needs refinement. The aim of this study was the identification of urinary biomarkers to predict the Prostate Imaging-Reporting and Data System (PI-RADS) score and the presence of PCa prior to prostate biopsy. Urine samples from patients with elevated PSA were collected prior to prostate biopsy (cohort = 99).

Transurethral injection of autologous muscle precursor cells for treatment of female stress urinary incontinence: a prospective phase I clinical trial.

Introduction And Hypothesis: The purpose was to investigate the safety and feasibility of transurethral injections of autologous muscle precursor cells (MPCs) into the external urinary sphincter (EUS) to treat stress urinary incontinence (SUI) in female patients.

Methods: Prospective and randomised phase I clinical trial. Standardised 1-h pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), urodynamic study, and MRI of the pelvis were performed at baseline and 6 months after treatment.

Quality Requirements for Medicinal Cannabis and Respective Products in the European Union - Status Quo.

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorizations for a couple of years. The Netherlands was the first member state to realize this; in the meantime other member states have followed. Today, aside from the Netherlands, Germany is the most important market for such products.

Identification of Urine Biomarkers to Improve Eligibility for Prostate Biopsy and Detect High-Grade Prostate Cancer.

PCa screening is based on the measurements of the serum prostate specific antigen (PSA) to select men with higher risks for tumors and, thus, eligible for prostate biopsy. However, PSA testing has a low specificity, leading to unnecessary biopsies in 50-75% of cases. Therefore, more specific screening opportunities are needed to reduce the number of biopsies performed on healthy men and patients with indolent tumors.

Validation of standardized high-performance thin-layer chromatographic methods for quality control and stability testing of herbals.

In herbal medicinal products the entire herbal drug or an herbal drug preparation is regarded as the active pharmaceutical ingredient, regardless of whether constituents with defined therapeutic activity are known. In quality control and stability testing of herbal medicinal products, fingerprint chromatograms are used as powerful tools to evaluate and compare the composition of compounds in such products. To fulfill the International Conference on Harmonization and Good Manufacturing Practice-based regulatory requirements in pharmaceutical quality control, chromatographic fingerprint analysis needs to be validated.

Validated method for the determination of six metabolites derived from artichoke leaf extract in human plasma by high-performance liquid chromatography-coulometric-array detection.

A validated method was developed for the simultaneous determination of the hydroxycinnamates caffeic (CA), dihydrocaffeic (DHCA), ferulic (FA), dihydroferulic (DHFA), and isoferulic acid (IFA) and the flavonoid luteolin (LUT) in human plasma as metabolites derived from artichoke leaf extract. The method involves sample preparation followed by separation using high-performance liquid chromatography on reversed-phase material with a polar endcapping (Aqua-C(18), 250 x 4.6 mm).

Pharmacokinetics and bioavailability of herbal medicinal products.

The use of herbs for treating various ailments dates back several centuries. Usually, herbal medicine has relied on tradition that may or may not be supported by empirical data. The belief that natural medicines are much safer than synthetic drugs has gained popularity in recent years and led to tremendous growth of phytopharmaceutical usage.

Urinary excretion and metabolism of arbutin after oral administration of Arctostaphylos uvae ursi extract as film-coated tablets and aqueous solution in healthy humans.

Bearberry leaves and preparations made from them are traditionally used for urinary tract infections. The urinary excretion of arbutin metabolites was examined in a randomized crossover design in 16 healthy volunteers after the application of a single oral dose of bearberry leaves dry extract (BLDE). There were two groups of application using either film-coated tablets (FCT) or aqueous solution (AS).

Systemic availability and pharmacokinetics of thymol in humans.

Essential oil compounds such as found in thyme extract are established for the therapy of chronic and acute bronchitis. Various pharmacodynamic activities for thyme extract and the essential thyme oil, respectively, have been demonstrated in vitro, but availability of these compounds in the respective target organs has not been proven. Thus, investigation of absorption, distribution, metabolism, and excretion are necessary to provide the link between in vitro effects and in vivo studies.

Evaluation of glucoiberin reference material from Iberis amara by spectroscopic fingerprinting.

Increasing worldwide regulations require increased efforts toward validation of analytical and pharmacological reference materials. A detailed survey of glucoiberin, a prototype lead constituent of therapeutic value, using 1D/2D NMR, MS, and X-ray spectroscopy provided precise phytochemical data for structure assignment. Quantitative reference validation was achieved by the recently proposed qNMR method.

Quantification of procyanidins in oral herbal medicinal products containing extracts of Crataegus species.

According to the European Pharmacopeia a photometric assay is used for the estimation of procyanidins in Crataegi fructus. This assay is also most commonly used for procyanidin analysis in herbal medicinal products (HMPs) containing extracts of hawthorn (Crataegus species). In order to find an appropriate method for the determination of oligomeric and polymeric procyanidins by analysing various preparations containing extracts of Crataegus, the Ph.

Determination of thymol in human plasma by automated headspace solid-phase microextraction-gas chromatographic analysis.

A reliable and sensitive method was developed for determination of thymol in human plasma by automated headspace solid-phase microextraction (SPME). After enzymatic cleavage of thymol sulfate thymol was extracted by a 65 microm polydimethylsiloxane-divinylbenzene crimped fiber (Supelco) after addition of sodium chloride and phosphoric acid (85%). Desorption of the fiber was performed in the injection port of a gas chromatograph at 220 degrees C (HP 5890; 50 m x 0.

Determination of ginsenosides from Panax ginseng using micellar electrokinetic chromatography.

A method for determination of ginsenosides in herbal medicinal products (HMPs) was developed using micellar electrokinetic chromatography (MEKC). Within 22 minutes 7 major ginsenosides were well separated. In order to demonstrate the accuracy, precision and robustness for the main target analyte the method was exemplarily validated for the determination of Rb1 according to ICH guidelines.