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Latest White Papers
Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
| By Molnár-Institute
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
Production & Manufacturing > Manufacturing > White Papers
Reagents for Fine Organic Synthesis – Building Blocks
| By Enamine
Renowned for supply of quality screening compound libraries, Enamine, a globally operating medicinal chemistry driven CRO, has developed the world’s largest catalogue of in-house designed and synthesized Building Blocks to complement its large offering of products for early stage drug discovery projects. The company pioneered the Building Block market in the early 2000’s capitalizing on its increasing chemistry experience and the growing number of Building Blocks it had synthesized for library design and numerous synthesis programs.
White Papers
Real-Time Investigation Services Using Instantaneous Microbial Detection
| By Azbil BioVigilant
In the pharmaceutical industry, product contamination poses a serious risk to manufacturing operations. If an out-of-specification event occurs, finding the root cause, taking remediation steps, and getting the manufacturing line back to full operational levels is critically important. Downtime on any manufacturing line can lead to a significant impact on the financial performance of the company.
Production & Manufacturing > Manufacturing > White Papers
Real-Time Particle Sizing for Granulation Control
| By Malvern Instruments
This paper considers various granulation processes and the use of real-time particle size measurement in their optimisation, focusing on two different sizing methods: laser diffraction and the spatial filter technique (SFT).
White Papers
Realize cost savings with new DisiTest 50 disintegration tester
| By Dr Schleuniger Pharmatron
Performing disintegration tests has mostly remained a time-consuming task where results are recorded manually and unproductive waiting & cleaning times represent a significant portion of daily machine utilization. The new DisiTest 50 disintegration tester from Dr. Schleuniger® Pharmatron incorporates innovative induction heating technology and combines it with the benefits of automation to realize cost savings by significantly streamlining the disintegration testing process.
White Papers
Reduced Solvent Consumption and Operational Costs with Existing LC Systems
| By Shimadzu PBR
Switching to the Prominence UFLC ultra-high-speed LC as a means of reducing solvent consumption and operational costs was introduced in Technical Report No. 24 "Reduced Solvent Consumption and Operational Costs with Ultra High Speed Analysis." Although introduction of ultra-highspeed LC is an effective way to conserve solvent, there is a very significant issue as to how this can be achieved with the existing LC systems in use. This report introduces detailed suggestions on how to most effectively reduce solvent consumption with existing LC systems.
White Papers
Reduced Solvent Consumption and Operational Costs with Ultra High Speed Analysis
| By Shimadzu PBR
HPLC-grade acetonitrile and methanol are used in many applications due to their chemical stability and low impurity content. Acetonitrile is generally used as a mobile phase more than methanol because (1) it subjects the column to less pressure to permit a longer column life, and (2) there are fewer obstructions in the short wavelength region in UV detection.
White Papers
Reducing Analysis Limitations by Using Multiple Detectors with Ultra-Fast LC
| By Shimadzu PBR
In HPLC method development, it is important not only to focus on the substance of interest, but also to pay attention to impurities. In both process and quality control, care must be taken with respect to unanticipated impurities in the sample to maintain a high level of product quality. When using ultra fast LC in particular, appropriate measures must be taken to ensure that impurities are not overlooked during the shortened analysis time achieved with higher speeds.
White Papers
Reducing Risk with the Right CRO Partner
| By INC Research
For drug developers, finding the right patients, investigators and outsourcing partners is essential. With shareholders demanding improved efficiencies, the resources, reach and expertise of a contract research organization (CRO) can expedite the research and development process.
White Papers
Reliability From Development to Service.
| By VITLAB®
VITLAB can look back on a history of almost 100 years. VITRI GmbH & Co. KG was founded in Mühltal (Germany) back in 1908. In 1989, the laboratory division was established as the independent company, VITLAB. Today, VITLAB is a leading manufacturer of liquid handling instruments and performance plastic products for one-time or long-term use. We develop and manufacture these products at our own production facility.
Drug Research > Drug Delivery > White Papers
Reliable, Long-range Wireless Sensors for Environmental Monitoring
| By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.
Contract Research & Services > Clinical Trials > White Papers
reMYND’s APP-London model and its bigenic combination with PS1[A246E]
| By reMYND
reMYND's APP[V717I] and APP[V717I] x PS1[A246E] transgenic amyloidopathy mouse models – biochemical and immunohistochemical characterization.
Contract Research & Services > Contract Research > White Papers
reMYND’s TAU[P301L] model and its bigenic combination with APP-London
| By reMYND
reMYND’s TAU[P301L] transgenic tauopathy mouse model – biochemical and immunohistochemical characterization.
Contract Research & Services > Contract Research > White Papers
Renal Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support
| By PRA Health Sciences
It is recommended to have renal impairment trials conducted relatively early in the clinical development process, because the outcome may influence the patient population as well as the inclusion and exclusion criteria of Phase II and III trials. The timing of these trials is generally before or in parallel with Phase II.
Contract Research & Services > Contract Research > White Papers
Revealing Kinase Inhibitor Mechanisms: ITC Leads the Way
| By Malvern Instruments
The kinome of an organism is the set of protein kinases in its genome and these protein-modifying enzymes are potential targets in a number of therapeutic areas. Studies to characterise the human kinome, together with the explosion of available kinase crystal structures over recent years, have led to an increased focus on kinases as potential targets for pharmaceutical intervention.
White Papers
Reverse Engineering of a Pharmaceutical Formulation Using the Morphologi G3-ID
| By Malvern Instruments
According to the definition established by the FDA, a generic drug is "a drug product which is comparable to a reference listed drug (RLD) product in dosage form, strength, route of administration, quality, performance characteristics, and intended use". Rigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these regulations to obtain FDA's approval.
White Papers
Reversed-Phase Analysis of Alkylbenzene Sulfonates
| By Tosoh Bioscience
Linear alkylbenzene sulfonates (LASs) are synthetic surfactants, which are produced by alkylation and sulfonation of benzene. LASs are a mixture of homologues and phenyl positional isomers, each containing an aromatic ring sulfonated at the para position and attached to a linear alkyl chain. The product is used in detergents and cleaning products for domestic and industrial use.
Drug Research > Drug Discovery & Development > White Papers
Review paper discussing the pathological hallmarks, clinical parallels, and value for drug testing in Alzheimer’s disease of the APP[V717I] London transgenic mouse model; also touching on reMYND’s other proprietary transgenic mouse models (Tanghe et al., 2010).
| By reMYND
Notwithstanding the vast amount of resources invested into discovery and development of new targets and treatments, Alzheimer’s disease (AD) remains an indication with enormous unmet needs. One complicating factor for successful drug development is the unknown etiology of idiopathic AD. AD entails noxious aggregation of β-amyloid (Abeta) and Tau, representing fundamental processes in disease onset and progression
Contract Research & Services > Contract Research > White Papers
Right Place, Right Time
| By Centrical Global Limited
Guy Patrick of Centrical Global Limited discusses operational risk management, its application in the delivery of clinical trials, and how it can help to facilitate faster and better quality results.
Contract Research & Services > Clinical Trials > White Papers
Risk - Based Monitoring for Late - Phase Research: Strategies for Real - World, Post - Approval Studies
| By PRA Health Sciences
The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV).
Contract Research & Services > Contract Research > White Papers
Risk Based Inspection Solutions - Improve Integrity, Reduce Costs Through More Effective inspection
| By ABB
Risk Based Solution (RBI) is a well proven approach for determining the optimum inspection plan for plant equipment. It uses a risk-based methodology to reduce risk, improve efficiency and lower the total costs of inspection. RBI has proven to be an effective tool for the optimisation of inspection strategies for vessels (columns, heat exchangers, filters, boilers, furnaces etc.), storage tanks, pipework, relief streams, civil structures, sumps and bunds.
Production & Manufacturing > Process & Production > White Papers
Risk Management Planning and Mandated Post - Authorisation Studies: Risk Management and Late Phase Studies for Real-World Research
| By PRA Health Sciences
Complex pharmacovigilance legislation in an evolving regulatory landscape has left drug makers searching for current, efficient and more meaningful solutions for their drug safety challenges, especially in the post-marketing arena. Companies are seeking expert advice and customised approaches to effectively collect, manage and analyse real-world evidence for a competitive advantage.
Contract Research & Services > Contract Research > White Papers
Russell Finex Helps ESTEVE Improve Sieving Accuracy & Product Quality at their Pilot R&D Plant in Barcelona
| By Russell Finex
With the installation of Finex 22™ machines with Vibrasonic® Deblinding Systems, ESTEVE improves the quality of their pharmaceutical formulations.
Production & Manufacturing > Process & Production > White Papers
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