Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy.

Potential of Chickpea Flours with Different Microstructures as Multifunctional Ingredient in an Instant Soup Application.

Chickpea flours are an interesting multifunctional ingredient for different food products. This study investigated the potential of differently processed chickpea flours as alternative thickening agents in an instant soup recipe, replacing potato starch. Dry instant soup powders were compared on bulk density and powder flowability, whereas prepared liquid instant soups were studied in terms of rheological behaviour (as influenced by microstructure) and volatile composition.

Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

Background: A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics.

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches.

The European Union's Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these.

Orphan Medicines for Pediatric Use: A Focus on the European Union.

Purpose: European policy makers have provided a number of incentives for the development of medicines for orphan diseases as early as 1999 through the Orphan Regulation and created obligations for medicines developers to investigate their products in children through the Paediatric Regulation adopted in 2006. This article describes the challenges that developers of orphan medicines are facing with pediatric indications, discusses the interplay between the Orphan Regulation and the Paediatric Regulation, and provides some recommendations on how to optimize drug development under the current European Union regulatory framework.

Methods: This article discusses the European Union's Orphan Regulation, Paediatric Regulation, and the implications of the intersection of the regulations on the development of orphan medicines for pediatric use.

Parametric amplification of 100 fs mid-infrared pulses in ZnGeP driven by a Ho:YAG chirped-pulse amplifier.

We report on the parametric generation of 100 fs sub-6-cycle 40 μJ pulses with the center wavelength at 5.2 μm using a 1 ps 2.1 μm pump laser and a dispersion management scheme based on bulk material.

Transverse and longitudinal characterization of electron beams using interaction with optical near-fields.

We demonstrate an experimental technique for both transverse and longitudinal characterization of bunched femtosecond free electron beams. The operation principle is based on monitoring of the current of electrons that obtained an energy gain during the interaction with the synchronized optical near-field wave excited by femtosecond laser pulses. The synchronous accelerating/decelerating fields confined to the surface of a silicon nanostructure are characterized using a highly focused sub-relativistic electron beam.

Ablation-cooled material removal with ultrafast bursts of pulses.

The use of femtosecond laser pulses allows precise and thermal-damage-free removal of material (ablation) with wide-ranging scientific, medical and industrial applications. However, its potential is limited by the low speeds at which material can be removed and the complexity of the associated laser technology. The complexity of the laser design arises from the need to overcome the high pulse energy threshold for efficient ablation.

Broadband mid-infrared pulses from potassium titanyl arsenate/zinc germanium phosphate optical parametric amplifier pumped by Tm, Ho-fiber-seeded Ho:YAG chirped-pulse amplifier.

We present a concept of a white-light-seeded-cascaded mid-infrared (mid-IR) optical parametric amplifier (OPA) based on potassium titanyl arsenate and zinc germanium phosphate nonlinear optical crystals and producing 100-μJ level pulses centered at 5300 nm, with the spectrum supporting four-optical-cycle pulse duration. The OPA is pumped by 2090-nm master oscillator/power amplifier based on a Tm,Ho-fiber laser seeder and a Ho:YAG regenerative amplifier delivering 3.8-mJ sub-ps pulses at a repetition rate of 1 kHz.

Using a Smartphone App and Coaching Group Sessions to Promote Residents' Reflection in the Workplace.

Problem: Reflecting on workplace-based experiences is necessary for professional development. However, residents need support to raise their awareness of valuable moments for learning and to thoughtfully analyze those learning moments afterwards.

Approach: From October to December 2012, the authors held a multidisciplinary six-week postgraduate training module focused on general competencies.

Compact polarization-maintaining 2.05-μm fiber laser at 1-MHz and 1-MW peak power.

We report on a compact all-polarization-maintaining 2.05-μm chirped pulse fiber amplifier system emitting pulses at up to 1-MW peak power level at 371-fs pulse duration. The seed pulse repetition rate provided by an inhouse-built oscillator is reduced to around 1 MHz using a pulse picker.

Broadband mid-IR frequency comb with CdSiP2 and AgGaS2 from an Er,Tm:Ho fiber laser.

We report on the generation of a 2500 nm bandwidth frequency comb at 6.5 μm central wavelength based on critically phase-matched parametric down-conversion in the nonlinear crystal CdSiP(2) (CSP), driven by a compact Er,Tm:Ho fiber laser. The generated ultra-broadband pulses show a transform-limited duration of 2.

Fiber chirped pulse amplifier at 2.08 μm emitting 383-fs pulses at 10 nJ and 7 MHz.

An all-polarization maintaining (PM) fiber chirped pulse amplifier system at 2.08 μm based on thulium:holmium codoped gain fibers is reported. An inhouse built oscillator emits pulses at a repetition rate of 7 MHz with a spectral full width at half-maximum (FWHM) bandwidth of 23.

All-PM coherent 2.05 µm Thulium/Holmium fiber frequency comb source at 100 MHz with up to 0.5 W average power and pulse duration down to 135 fs.

We report on a dual output all-PM fiber laser system running at 100 MHz repetition rate offering coherent broadband and narrowband pulses centered at 2.05 µm with a spectral FWHM bandwidth of 60 nm and 1.5 nm at up to 360 mW and 500 mW, respectively.

An evidence-based mobile decision support system for subaxial cervical spine injury treatment.

Bringing evidence to practice is a key issue in modern medicine. The key barrier to information searching is time. Clinical decision support systems (CDSS) can improve guideline adherence.

The effect of sacral nerve stimulation on uterine activity: a pilot study.

Introduction: Sacral nerve stimulation (SNS) is a treatment for consecutive therapy resistant faecal incontinence or constipation. Little is known about the effects of SNS on uterocervical function. Therefore, it is advised to turn off the stimulator during pregnancy or to wait with permanent implantation of the stimulator until family completion.

Intrauterine manipulation does not adversely influence the direction and frequency of endometrial waves.

Objective: To investigate whether intrauterine manipulation affects the direction or alters the frequency of endometrial wavelike activity.

Design: Prospective observational study.

Setting: University hospital-based fertility clinic.

Complex endometrial wave-patterns in IVF.

Objective: To reanalyze ultrasound images from IVF cycles with the aim of developing a refined endometrial wave classification system, which will allow description as well of the more complex endometrial wave patterns.

Design: Descriptive study.

Setting: University hospital-based fertility clinic.

Endometrial waves in in vitro fertilization cycles: a validation study.

In a prospective validation study we could not confirm that the persistence of endometrial waves from fundus to cervix on the day of hCG administration is associated with a favorable pregnancy prognosis in patients undergoing IVF.

Endometrial wave-like activity in the non-pregnant uterus.

The non-pregnant uterus shows wave-like activity throughout the menstrual cycle. This uterine activity was first detected using intra-uterine pressure recordings. The use of ultrasound has made it possible to study the movements of the uterus in a non-invasive manner.

Sampling plans for the determination of aflatoxin B1 in large shipments of animal feedstuffs.

Incremental samples (50, 100, and 500 g) were systematically collected from large shipments of copra meal pellets, copra cake, and palm kernel cake to study the distribution of aflatoxin B1 and evaluate adherence of distribution to the model, CV(2)is (EQ) = A + B/Mis (where CVis = coefficient of variation of the true concentration of aflatoxin B1 within the incremental samples; Mis = mass of the incremental samples; and A and B are constants). Also evaluated was the distribution of aflatoxin B1 among 1 kg composite samples, produced both by random combination of existing incremental samples and by collection of 1 kg composite samples (composed of 10 x 100 g increments) from additional batches of copra meal pellets and cottonseed cake. The efficiency of selected sample preparation (grinding and subdivision) procedures was compared, culminating in the development and description of a variety of sampling plans.

Three months use of third-generation oral contraceptives does not affect artery wall properties.

In several studies, artery wall properties have been shown to differ between men and women. It has been hypothesized that these differences may result from hormonal influences but, in a previous study, we were unable to detect any influence of the menstrual cycle on artery wall properties. Therefore, we investigated the differences in artery wall properties, if any, between the menstrual cycle and the use of a third-generation oral contraceptive for 3 months.

Endometrial wave direction switch and the outcome of in vitro fertilization.

Objective: To describe endometrial wavelike activity, endometrial thickness and texture in IVF cycles, and to relate them to IVF outcome. To evaluate wave patterns on the day of hCG administration as a predictor of IVF outcome.

Design: Ultrasound study.

Bladder filling reduces femoral artery wall distension and strain: beware of a full bladder!

During a previous study, we noted that the distension and strain of the femoral artery were relatively low when the bladder was full, a situation normally necessary for transabdominal echography. Therefore, in the present study we investigated the influence of bladder filling, if any, on wall properties of the common femoral artery. The results obtained were compared with those obtained in the common carotid artery.