The aim of this study was to develop dry powder formulations for inhalation containing API alone and API in combination with coarse carrier particles (lactose monohydrate) for a Phase I first in man clinical study within six months from API delivery.
Our webinar presents an overview of the potential advantages of a biomarkers strategy in the context of drug discovery and development to deliver new medicines into the market.
The development of highly potent active pharmaceutical ingredients is a difficult task for many. However, companies can adopt a number of practices to ensure a smoother, safer process. This article is taken from Pharmaceutical Manufacturing and Packing Sourcer November 2017, pages 14-16. © Samedan Ltd.
Recently presented at AAPS 2017 by our expert, Paola Bisol, in collaboration with Neurocrine Biosciences, download your copy of this poster now and discover more assay and impurity content analysis.
Recently presented at AAPS 2017 by our expert Cesare Di Palma, in collaboration with Sunesis, download your copy of this scientific poster and learn more about hot melt extrusion for toxicology studies and Phase I clinical trials.
Recently presented by our expert, Paola Bisol, in collaboration with Neurocrine Biosciences, at AAPS 2017, download your copy of this scientific poster today and discover more about the use of pepsin to address in vitro extraction issues.
Recently presented by our expert, Emanuela Del Vesco, in collaboration with Sunesis, at AAPS 2017, download your copy of our scientific poster today and discover more about VIT E TPGS in preclinical formulation.
Respiratory diseases severely affect the quality of life of millions and is one of the major causes of death worldwide. In 2013, lung disease accounted for 400,000 deaths in the EU, equivalent to 8% of the total mortality figure. Get your copy of our insightful infographic today to check you're considering these factors during pulmonary drug development.
This scientific poster discusses key topics including how, in order to claim GLP compliance -
• SEND should be included in GLP protocol
• SEND process/output should be audited by QA
• Study Director will be accountable for the dataset
New guidelines by the USP and the ICH will come into force on January 1st, 2018, specifying more stringent permitted daily exposure (PDE) limits for elements of toxicological concern in drug products and drug substances. The same guidelines mandate the use of inductively coupled plasma (ICP) technology for testing pharmaceuticals and their ingredients for elemental impurities. Read the article and discover how this could impact you.
In this article we consider the advantages of adopting an integrated approach to drug development while navigating the regulatory requirements around abuse liability assessment.
High content imaging (HCI) offers a robust, high throughput analysis of large numbers of cells with the benefit of the spatial and temporal information obtained with fluorescence microscopy. This webinar provides an overview of the advantages of HCI-based over the more traditional, homogenous assays, and how this technology is being applied at Aptuit for drug discovery purposes.
In an effort to characterize novel inhibitors of multivirulence factor regulator (MvfR) the need to develop a chronic lung infection model became apparent. Clinical isolates from sputum of chronic cystic fibrosis patients have been characterized by measuring QS molecules levels and biofilm biomass in vitro. Among these strains, ACC00901 was identified as QS molecule and biofilm hyperproducer strain comparable with PA01 and selected to set-up a chronic lung infection model rat by loading bacteria into agar beads.
Unwanted effects of drugs on neurobehavioural and cardiovascular functions are normally assessed in separate studies and using different animals.
This webinar focuses on a new model using dogs which allows for the integration of these assessments into a single study to be established and validated.
Candidate selection is the result of the combined and dedicated effort of a multidisciplinary team of scientists who progress hits and leads utilizing a number of strategies and approaches which are summarized below and will be described in this webinar:
Darzens reactions are commonly run in the presence of strong anionic bases such as alkali metal hydroxides or alkoxides, sodium amide, LDA, LiHMDS or n-butyllithium, very often with pre-formation of the reactive ester enolate anion. To the best of our knowledge, there are not examples of Darzens reaction involving uncharged organobase. Prompted by this information, we surveyed the activity of readily available organobases with different pKBH+3 in the Darzens condensation between α-halo esters and aromatic aldehydes.
Harnessing the full power of iPSCs in all aspects of drug discovery is hampered by various challenges. This webinar discusses:
Welcome to INSIDE Drug Discovery and Development, our very own publication which brings together our latest thinking and insights in all things drug discovery. This issue discusses the current status/understanding of drug discovery in the respiratory disease area. Particular focus is given to idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF) and asthma.
This scientific poster aims to provide a new chemical starting point to seed future drug discovery efforts. Despite the 5500 compounds already synthesized by both companies and academia, is it still possible to design a novel PDE4 inhibitor series?
This webinar briefly describes the cellular populations of the central nervous system, their functions and interrelationships and is aimed at an audience of training pathologists both in the veterinary or toxicology fields.
This webinar offers a short overview on the CNS cytopathology; and additionally, the most common handling/fixation artifacts and neuroanatomic structures that can be confused with lesions. This webinar is aimed to an audience of training pathologists both in the veterinary or toxicology fields.
This webinar will -
Automated coulometric KF with oven, when feasible, allows the analysis of a large sample number and requires a small amount of sample. This webinar discusess how to approach a method development using this technique.
Recently presented at IDDST 2017 by our expert, Luca Raveglia, this presentation focuses on attrition rate in Drug Discovery and Development and Lead Optimization strategies.
In this webinar, Wayne examines capsule based Dry Powder Inhaler (DPI) for Phase I, and in particular, addresses the following areas -
Part two of this two part webinar mini-series presents some real examples about the use of SFC technology in chiral separations and the role of Circular Dichroism (CD) detection, in particular:
Part one of this two part webinar mini-series presents aspects about SFC technology, in particular:
This webinar discusses approaches for the bio-availability enhancement of oral dosage from drug products. Including: solid dispersions, nano-suspensions and lipidic formulations and targeted delivery.
Recently presented by our expert, Vanesa Garrido Estevez, a structure-based in silico screening approach was performed following docking studies on
M64, a compound showed to inhibit the MvfR regulon, in order to search for novel inhibitors of MvfR protein.
Quality by Design (QbD) aims to deliver the safe, effective drug supply to the patients/ consumers, and also offers significant improvement to manufacturing quality performance. This webinar examines and analyses why QbD in the early clinical phase development is useful.
Recently presented at RICT 2017 by our expert, Marta Giuliani, download your copy of this scientific poster now and discover more about Glycocalixarenes' combination with traditional liposomes to produce new potential systems for efficient and specific targeted drug delivery, based on carbohydrate-protein recognition.
It is widely accepted that CNS drugs need to have some distinctive physchem properties to penetrate the blood-brain barrier and exhibit CNS activity. This webinar addresses the concept of CNS Drug Efficiency, methods used to model DrugEff and the summarises the analysis found and what is the best option.
This article reviews the issues specific to developing drugs designed for pulmonary delivery and considers how - with the right knowledge and expertise - these challenges can be overcome.
This webinar introduces you to systems biology approaches in drug discovery; providing an overview on biological networks and network analysis and examples on application of systems biology approaches in Drug Discovery in two areas of research: target identification (Alzheimer's) and Biomarkers discovery.
Recently presented by our expert Francesco Rossignolo at the 14th European meeting of the International Society for the Study of Xenobiotics (ISSX) in Germany, download your copy of this scientific poster today and discover more about CYP induction.
Recently presented by our expert, Rosaria Remelli, at the Drug Discovery Summit in Berlin, discover more about HCA application with this educational presentation.
The aim of this webinar is to highlight the critical aspects related to the test system in the genetic toxicology testing, and to provide insights on its characterization, to ensure the required quality standards.
This webinar looks at some of the different types of genetic toxicity testing, including the Ames test: modified pre-incubation test, Chromosome Abberation test: longer harvesting test time and the Micronucleus test: CREST/FISH kinetochore test.
There is an increasing interest in developing novel molecules especially if endowed with UV filtering and antioxidant activity. This scientific poster focuses on the synthesis of polyphenols and the evaluation of antioxidants as the first line of defense against skin cancer and early photo-ageing.
Presented by our expert, Mark Saunders, this presentation discusses the challenges in designing dose vehicles for preclinical studies, gastro-intestinal physiology considerations of common animal models and examines case stdies including pH variability, GI volume, metabolism and digestion.
Here, we draw on the experience of Mark Saunders, to find out more about how taking an integrated approach to drug formulation as early as possible in drug development can produce the best possible products with the greatest chance of success.
A discovery program was initiated to discover novel, potent inhibitors of MvfR regulon, starting from a chemical series firstly reported by L Rahme. Here we describe the design and the in vitro characterization of a novel chemical series of MvfR inhibitors designed from M64 taken as the prototype molecule.
This webinar, from our expert Raffaella Ricci, discusses the features and the potential applications of RapidFire system in DMPK assays along with HighThroughPut screenings.
In this webinar, Stephan Fasler addresses Hit identification through High-throughput screening. The main areas of discussion are around Hit discovery, lead-like compound collection and screening cascade. Listen now!
Using computational filters to exclude so-called Pan-Assay Interference Compounds, or PAINS, from high throughput screening campaigns has become increasingly common in drug discovery circles. But while the industry is right to be vigilant about ‘frequent hitters’(compounds that show misleading readouts in multiple biological assays) new findings add to growing concern that we blindly follow PAINS filters at our peril.
Part one of this three-part mini-series introduces Quality by Design (QbD) concepts applied to Active Pharmaceutical Ingredient and Drug Product. This webinar is aimed at an audience that does not have much experience with QbD.
Part two of this three-part mini-series presents case studies on the application of QbD concepts. This webinar is aimed at both new, and more experienced, people who are interested in the practical application.
This final webinar of the series discusses QbD at the pre-formulation stage and the approach to process development. With a focus on Drug Product case studies, QbD at Pre-formulation stage and approaches to Process Development.
One of the main goals in stem cells biology is the identification of factors regulating self-renewal and differentiation. In this poster, the role of BMPR1A receptor in mouse Embryonic Stem Cells (mESCs) was investigated in in vitro differentiation.
Presented by Alfonso Pozzan at the CHI 2017 Drug Discovery Chemistry conference, this scientific poster discusses the concept of Drug Efficiency (Deff) in Lead Optimization, the use of Deff in CNS marketed drugs and addresses the future of Deff. Get your copy now!
Presented by Alfonso Pozzan at CHI Drug Discovery Chemistry 2017, this presentation discusses the concept of CNS Drug Efficiency, the methods used to model DrugEff and analysis to summarise what the best option is.
Recently presented by our Director, Medicinal Chemistry, Daniele Andreotti, at ECCMID 2017, get your copy of this educational scientific poster today to review the research program that was initiated to discover novel, potent inhibitors and examine the results and data of prototype compound M64.
Paul Overton, Aptuit’s Executive Vice President of business development and marketing, a scientist by background, talks to Jo Shorthouse about the evolving R&D
model and how the CRO industry can work creatively on early stage research.
Antimicrobial resistance poses one of the biggest threats to public health faced in modern times. Left unchecked, it’s thought that by 2050 the global number of deaths from antimicrobial resistance may be as high as 10 million per year. In addition to the human cost, the financial burden will be substantial. Download this scientific article today and discover more.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive pathology which leads to a gradual loss of pulmonary function. The pathology is characterised by accumulation of fibrotic tissue due to abnormal ECM remodelling. Currently, the market only offers therapies targeting the symptoms, rather than the causes, which are largely unknown. This article covers current treatment options, targets and current pipeline and looks ahead to the development of novel compounds.
Our report, "A rising future: The dynamics of the growing respiratory drug market" discusses the currently available treatments for respiratory diseases, our main challenges, and finally what lies ahead.
Central to drug development is the Active Pharmaceutical Ingredient (API), the synthesis of which is no easy feat. Download this API eBook and ensure you know how to successfully pass each milestones.
Our latest ebook has been created to help unravel the drug discovery process and provide guidance on how to save time, money and resources while increasing your chances of success. Read it for an overview of the dynamic stages of the drug discovery process and key factors to consider to increase your chances of success.
Presented at EBF 2016, this scientific poster showcases the development and validation of a bioanalyticaly method for quantification of LNA-i-miR-221, a 13-mer oligonucleotide, in rat plasma using LC-MS/MS.
Recently presented at EBF 2016, download your copy of the educational 'Compliance and work efficiency improvements through implementation of a UNIFI Network' presentation and discover more about the key aspects of regulated Bioanalysis.
Recently presented at EBF 2016, download your copy of the educational presentation, 'Benefits of high sensitivity clinical case studies and overall lab productivity' and explore two case studies in detail.
Recently presented at SLAS 2017, download your copy of this scientific poster and understand more about MITRA sampling technology for drug discovery PK studies.
Listen to this informative webinar and find out how to overcome the challenges of preclinical formulation development.
Recently presented by our experts at EBF 2016, discover more about Protein X antibodies in mouse serum samples with this scientific poster.
Presented at AAPS 2016, discover more with this case study about in vitro dissolution screening for PK formulation selection for poorly water-soluble drugs.
In this webinar we discuss how Quality by Design principles, introduced in the ICH Q8, Q9, Q10 and Q11, were used to support development studies for Drug Substance and Drug Product.
Discover the advantages of applying a workflow driven approach to assay request and data collection in drug discovery and development organisations.
Presented at AAPS 2016, download this scientific poster to find out more about enabling technology screening and formulation selection in poorly water-soluble drugs.
This webinar provides insights about approaches to characterize and modify the API particle attributes to fit formulation need.
Recent successes of immunomodulatory approaches for the treatment of serious diseases such as cancer have generated a significant growth in efforts aimed at the discovery...
In this webinar Antonio Felici discusses antibacterial resistance and the need for new and right antibiotics, providing examples of innovative discovery approaches.
Stephen Gorsuch presents our webinar discussing how to ensure your active pharmaceutical ingredient outsourcing activities are as successful as possible
Watch our webinar discussing accelerated stability assessment programs (ASAP) to improve product development.
In this webinar we address the influence of drug solid state properties on solubility and applications to pharmaceutical products development.
Watch our webinar on Pharmaceutical abuse liability assessments. In this we address the definitions of Abuse Liability, scheduling process, implications and guidelines, general principles and considerations, methods (tiered approach) and preclinical studies (methods and examples).