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Medicinal-Pharmaceutical Chemistry Commons™
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Articles 1 - 30 of 47
Full-Text Articles in Medicinal-Pharmaceutical Chemistry
Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff
Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff
Level 3
The U.S. has faced long-standing shortages of generic drugs, causing negative health effects and spikes in drug costs. To address these shortages, investments in critical technologies and policies to support their adoption will be needed. The success of these technologies and policies depends on public acceptance. We studied public acceptance using the mental model approach, which identifies gaps in understanding that can be addressed with communications. We began with semi-structured interviews with experts in pharmaceutical manufacturing. Based on these interviews, we developed and conducted surveys of the general public, physicians, and pharmacists. Similar strategies could be applied to improve communications …
Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland
Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland
Level 3
No abstract provided.
Agenda From June 1st Conference
Hpra’S Kevin O’Donnell On The Ich Q9 Revision And Considerations For Its Implementation, Kevin O'Donnell
Hpra’S Kevin O’Donnell On The Ich Q9 Revision And Considerations For Its Implementation, Kevin O'Donnell
Level 3
At the June 2023 PRST meeting on the ICH Q9 revision, HPRA Market Compliance Manager and Senior GMP Inspector Kevin O’Donnell, who has been serving as rapporteur for ICH Q9 (R1), addressed the changes introduced in the revision, the practicalities of implementation, and his “personal thoughts” on the implementation process. Click here for ICH Q9(R1) with the changes highlighted by O’Donnell, and here for the slides accompanying O’Donnell’s remarks. Formatting
changes and other minor edits have been made for clarity by IPQ. Expressions of thanks to the meeting organizers/attendees and disclaimers that the presentation represents the speaker’s views and not …
Balancing Quality Assurance & Innovation In Pharma, Emma Ramnarine
Balancing Quality Assurance & Innovation In Pharma, Emma Ramnarine
Level 3
At the Pharmaceutical Regulatory Science Team (PRST) workshop on ICH Q9(R1), held at the Technological University Dublin in early June 2023, Boehringer Ingelheim US Biopharma Operations Product Management & Development Operations Head Emma Ramnarine shared her insights on balancing quality assurance and innovation in pharmaceutical manufacturing. She addressed: ● patient-centered transformation ● a watershed moment in her career ● understanding the drug shortage problem ● disruptive collaboration, and ● systems thinking
approaches. Click here for the slides accompanying Ramnarine’s remarks. She connected some of her remarks for the pharmaceutical industry to those made in the previous talk by Ed Hoffman, …
Quality Reborn, Anders Vinther
Quality Reborn, Anders Vinther
Level 3
It is time for Quality leaders to not only fulfill the traditional role of ensuring cGMP compliance within the company but also take the Quality profession to the level of business leadership like Deming did in Japan after World War II. FDA has recently stated that they have low confidence in quality management maturity of the pharmaceutical industry.
For quality leaders to also become good business leaders we must educate them in ways that are different from what we currently do. The education should be in the 6 areas
- Visibly Demonstrating Responsibility of Quality
- Risk-Informed Decision Making and Communication
- Engaging …
Preface, Anne Greene, Martin Lipa, Bill Paulson
Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe
Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe
Level 3
This article is based on a presentation given at the event ICH Q9(R1): The Next Frontier hosted by TU Dublin, Grangegorman 01-June-2023
An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient
Introducing Research Collaboration And Gmp Human Resource Development At Three Universities With Gmp Laboratories In Japan, Shingou Sakurai, Osamu Hiruta, Ryoko Naruse
Introducing Research Collaboration And Gmp Human Resource Development At Three Universities With Gmp Laboratories In Japan, Shingou Sakurai, Osamu Hiruta, Ryoko Naruse
Level 3
This paper summarises initiatives presented on June 1st 2023 at a seminar during a visit to Technological University Dublin. The authors travelled from 3 universities in Japan to share some of the collaborative research, education and training initiatives developed by them,
In their presentation the authors gave an overview of the current situation of Knowledge Management and Quality Culture in Japan, highlighting some recent issues and challenges, and presented some initiatives under development to specifically address these challenges.
Leveraging Advanced Analytics In The Pharmaceutical Industry, Patrick O'Sullivan
Leveraging Advanced Analytics In The Pharmaceutical Industry, Patrick O'Sullivan
Level 3
This article is a transcribed and lightly edited version of Patrick O’Sullivan’s oral presentation to a seminar hosted on 1 June 2023 by the Pharmaceutical Regulatory Science Team (PRST), TU Dublin, titled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Patrick presented an overview of how one could leverage advanced analytics in the pharmaceutical Industry.
Regulators Are Exploring With Industry How To Strengthen Quality Risk Management Practices, With Revision Of Ich Q9 A Key Focal Point, ( Ipq )
Level 3
No abstract provided.
Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative, ( Ipq )
Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative, ( Ipq )
Level 3
No abstract provided.
Exploring The Role Of Knowledge In The Pharma Workplace Of The Future: An Interactive Workshop Exploring Culture, Km And Opex, Stephanie Friedrichsen, Nuala Calnan (Editor), Martin J. Lipa
Exploring The Role Of Knowledge In The Pharma Workplace Of The Future: An Interactive Workshop Exploring Culture, Km And Opex, Stephanie Friedrichsen, Nuala Calnan (Editor), Martin J. Lipa
Level 3
This article presents a summary of an interactive workshop facilitated by Nuala Calnan and Stephanie Friedrichsen during the conference: ‘ICH Q9(R1): The Next Frontier’ held in Technological University Dublin, Ireland, on 1 June 2023. The summary was prepared by the workshop facilitators in conjunction with Martin Lipa who was a participant at the workshop. The article is written to give a high-level overview of the discussions which took place during the workshop and is not intended to be a complete representation of all the activities, insights and findings.
Links To Prst Past Monographs And Level 3 Special Editions
Links To Prst Past Monographs And Level 3 Special Editions
Level 3
No abstract provided.
Ipq Bibliography Pac Km Qrm 2010 - 2023
Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) Part 3: Uncovering Knowledge For Qrm Through Knowledge Mapping At Node 1, Martin Lipa, Valerie Mulholland, Anne Greene
Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) Part 3: Uncovering Knowledge For Qrm Through Knowledge Mapping At Node 1, Martin Lipa, Valerie Mulholland, Anne Greene
Articles
To date, literature on the Risk-Knowledge Infinity Cycle (RKI Cycle) has mainly been theoretical. This paper series intent is to focus on the operationalisation of the RKI Cycle by describing a series of steps – the “How to” – for RKI Cycle deployment, to help move the RKI Cycle from theory to practice. The third paper in this series focuses on ensuring the best available knowledge flows into QRM through a case study demonstrating knowledge mapping to support effective quality risk assessment during commissioning and qualification activities.
Assessing The Correlation Of Microscopy-Based And Volumetry-Based Measurements For Resin Swelling In A Range Of Potential Greener Solvents For Spps, Jordan K. Magtaan, Marc Devocelle, Fintan Kelleher
Assessing The Correlation Of Microscopy-Based And Volumetry-Based Measurements For Resin Swelling In A Range Of Potential Greener Solvents For Spps, Jordan K. Magtaan, Marc Devocelle, Fintan Kelleher
Articles
The degree of resin swelling in a particular solvent system is one of the critical parameters for SPPS, and for solid phase synthesis, in general. Methods used for measuring the degree of resin swelling include microscopy-based and volumetry-based methods. This study describes, and compares, the use of both methods for a number of commercially available resins commonly used in SPPS, with a range of solvents which have been identified in the literature as “greener” than DCM, DMF and NMP. The results were analysed by statistical methods and a significant correlation between the two distinct methods has been demonstrated for the …
Singlet Oxygen Generation By Porphyrins And Metalloporphyrins Revisited: A Quantitative Structure-Property Relationship (Qspr) Study, Andrey A. Buglak, Mikhail Filatov, Althaf M. Hussain, Manabu Sugimoto
Singlet Oxygen Generation By Porphyrins And Metalloporphyrins Revisited: A Quantitative Structure-Property Relationship (Qspr) Study, Andrey A. Buglak, Mikhail Filatov, Althaf M. Hussain, Manabu Sugimoto
Books/Book chapters
state followed by formation of singlet oxygen (1O2), which is a highly reactive species and mediates various oxidative processes. The design of advanced sensitizers based on porphyrin compounds have attracted significant attention in recent years. However, it is still difficult to predict the efficiency of singlet oxygen generation for a given structure. Our goal was to develop a quantitative structure-property relationship (QSPR) model for the fast virtual screening and prediction of singlet oxygen quantum yields for pophyrins and metalloporphyrins. We performed QSPR analysis of a dataset containing 32 compounds, including various porphyrins and their analogues (chlorins and bacteriochlorins). Quantum-chemical descriptors …
Spheroid-3d And Monolayer-2d Intestinal Electrochemical Biosensor For Toxicity/Viability Testing: Applications In Drug Screening, Food Safety, And Environmental Pollutant Analysis, Evangelia Flampouri, Shahzad Imar, Kieran O'Connell, Baljit Singh
Spheroid-3d And Monolayer-2d Intestinal Electrochemical Biosensor For Toxicity/Viability Testing: Applications In Drug Screening, Food Safety, And Environmental Pollutant Analysis, Evangelia Flampouri, Shahzad Imar, Kieran O'Connell, Baljit Singh
Articles
The rise of three-dimensional cell culture systems that provide in vivo-like environments for pharmaco-toxicological models has prompted the need for simple and robust viability assays suitable for complex cell architectural structures. This study addresses that challenge with the development of an in vitro enzyme based electrochemical sensor for viability/cytotoxicity assessment of two-dimensional (2D) monolayer and three-dimensional (3D) spheroid culture formats. The biosensor measures the cell viability/toxicity via electrochemical monitoring of the enzymatic activity of nonspecific esterases of viable cells, through the hydrolysis of 1-naphthyl acetate to 1-naphthol. The proposed sensor demonstrated strong correlation (r = 0.979) with viable …
Conformational Studies Of Gram-Negative Bacterial Quorum Sensing Acyl Homoserine Lactone (Ahl) Molecules: The Importance Of The N→* Interaction, Fintan Kelleher, Goar Sánchez-Sanz, Darren Crowe, Alan Nicholson, Adrienne Fleming
Conformational Studies Of Gram-Negative Bacterial Quorum Sensing Acyl Homoserine Lactone (Ahl) Molecules: The Importance Of The N→* Interaction, Fintan Kelleher, Goar Sánchez-Sanz, Darren Crowe, Alan Nicholson, Adrienne Fleming
Articles
A 1H NMR study shows the presence of intermolecular hydrogen bonds for AHLs in CDCl3 solution. A detailed computational study of the structure of AHLs and the relative stability between the extended conformations (X) and those showing n→p* interactions (np) have been carried out by means of DFT calculations. Solvent effects have been shown to be very important when stabilising np conformations, particularly with polar solvents. This was shown by the shortening of C···O intramolecular distances and the increase in the relative energies favouring the np conformation with the dielectric constant of the solvent. …
In Vitro Label Free Screening Of Chemotherapeutic Drugs Using Raman Micro-Spectroscopy: Towards A New Paradigm Of Spectralomics., Zeineb Farhane, Haq Nawaz, Franck Bonnier, Hugh Byrne
In Vitro Label Free Screening Of Chemotherapeutic Drugs Using Raman Micro-Spectroscopy: Towards A New Paradigm Of Spectralomics., Zeineb Farhane, Haq Nawaz, Franck Bonnier, Hugh Byrne
Articles
This overview groups some of the recent studies highlighting the potential application of Raman micro-spectroscopy as an analytical technique in preclinical development to predict drug mechanism of action and in clinical application as a companion diagnostic and in personalised therapy due to its capacity to predict cellular resistance and therefore to optimise chemotherapeutic treatment efficacy.
Notably, the anthracyclines, Doxorubicin and Actinomycin D, elicit similar spectroscopic signatures of subcellular interaction characteristic of the mode of action of intercalation. Although Cisplatin and Vincristine show markedly different signatures, at low exposure doses, their signatures at higher doses show marked similarities to those elicited …
Targeting The Folate Receptor: Improving Efficacy In Inorganic Medicinal Chemistry, Pauraic Mccarron, Aisling Crowley, Denis O'Shea, Malachy Mccann, Orla L. Howe, Mary Hunt, Michael Devereux
Targeting The Folate Receptor: Improving Efficacy In Inorganic Medicinal Chemistry, Pauraic Mccarron, Aisling Crowley, Denis O'Shea, Malachy Mccann, Orla L. Howe, Mary Hunt, Michael Devereux
Articles
The discovery of the high-affinity, high-specificity folate receptor in mamalian kidney cells, coupled with the ability of folate to enter cells by folate receptor-mediated endocytosis and the subsequent elucidation of the folate receptor’s overexpression in specific cancer cell types; heralded the arrival of the area of chemotherapeutic folate targeting. The application of purely organic folate-based small-molecule drug conjugates that selectively target the folate receptor, which is over expressed in several diseases such as cancer, is well established. The application of inorganic folate-targeted drugs offers significant potential to expand and enhance this therapeutic approach. From the data made available to date, …
Antifungal Potential Of Copper(Ii), Manganese(Ii) And Silver(I) 1,10-Phenanthroline Chelates Against Multidrug-Resistant Fungal Species Forming The Candida Haemulonii Complex: Impact On The Planktonic And Biofilm Lifestyles, Rafael M. Gandra, Pauraic Mc Carron, Mariana F. Fernandes, Lívia S. Ramos, Thaís P. Mello, Ana Carolina Aor, Marta H. Branquinha, Malachy Mccann, Michael Devereux, André L. S. Santos
Antifungal Potential Of Copper(Ii), Manganese(Ii) And Silver(I) 1,10-Phenanthroline Chelates Against Multidrug-Resistant Fungal Species Forming The Candida Haemulonii Complex: Impact On The Planktonic And Biofilm Lifestyles, Rafael M. Gandra, Pauraic Mc Carron, Mariana F. Fernandes, Lívia S. Ramos, Thaís P. Mello, Ana Carolina Aor, Marta H. Branquinha, Malachy Mccann, Michael Devereux, André L. S. Santos
Articles
Candida haemulonii, Candida haemulonii var. vulnera and Candida duobushaemulonii, which form the C. haemulonii complex, are emerging etiologic agents of fungal infections known to be resistant to the most commonly used antifungals. The well-established anti-Candida potential ofmetal complexes containing 1,10-phenanthroline (phen) ligands encouraged us to evaluate different copper(II), manganese(II), and silver(I) phen chelates for their ability to inhibit planktonic growth and biofilm of C. haemulonii species complex. Two novel coordination complexes, {[Cu(3,6,9-tdda)(phen)2].3H2O.EtOH}n and [Ag2(3,6,9-tdda)(phen)4].EtOH (3,6,9-tddaH2 = 3,6,9-trioxaundecanedioic acid), were synthesized in a similar fashion to the other, previously documented, sixteen copper(II), manganese(II), and silver(I) chelates employed herein. Three isolates of …
Formulation, Characterisation And Stability Assessment Of A Food Derived 1 Tripeptide, Leucine-Lysine-Proline Loaded Chitosan Nanoparticles, M.K. Danish, Giuliana Vozza, Hugh Byrne, Jesus Maria Frias, Sinead Ryan
Formulation, Characterisation And Stability Assessment Of A Food Derived 1 Tripeptide, Leucine-Lysine-Proline Loaded Chitosan Nanoparticles, M.K. Danish, Giuliana Vozza, Hugh Byrne, Jesus Maria Frias, Sinead Ryan
Articles
The chicken or fish derived tripeptide, Leucine-Lysine-Proline (LKP), inhibits the Angiotensin Converting Enzyme and may be used as an alternative treatment for pre-hypertension. However, it has low permeation across the small intestine. The formulation of LKP into a nanoparticle (NP) has the potential to address this issue. LKP-loaded NPs were produced using an ionotropic gelation technique, using chitosan (CL113). Following optimisation of unloaded NPs, a mixture amount design was constructed using variable concentration of CL113 and tripolyphosphate at a fixed LKP concentration. Resultant particle sizes ranged from 120-271 nm, zeta potential values from 29-37 mV and polydispersity values from 0.3-0.6. …
Solid-Phase Peptide Synthesis Of Analogues Of The N-Terminus A-Ring Fragment Of The Lantibiotic Nisin: Replacements For The Dehydroalanine (Dha) Residue At Position 5 And The First Incorporation Of A Thioamide Residue, Kim Manzor, Keith Ó Proinsias, Fintan Kelleher
Solid-Phase Peptide Synthesis Of Analogues Of The N-Terminus A-Ring Fragment Of The Lantibiotic Nisin: Replacements For The Dehydroalanine (Dha) Residue At Position 5 And The First Incorporation Of A Thioamide Residue, Kim Manzor, Keith Ó Proinsias, Fintan Kelleher
Articles
A number of A-ring analogues of the lantibiotic nisin, containing replacements for the Dha at position 5, have been successfully prepared by solid-phase peptide synthesis. The Dha replacements include glycine, alanine, phenylalanine, serine and 1-aminocyclopropyl carboxylic acid (ACCa). The incorporation of a thioamide-isoleucine residue at position 4 is also described and is the first report of the preparation of a lantibiotic ring fragment containing a thioamide link.
Conformational Studies Of Gram-Negative Bacterial Quorum Sensing 3-Oxo N-Acyl Homoserine Lactone Molecules, Darren Crowe, Alan Nicholson, Adrienne Fleming, Ed Carey, Goar Sanchez-Sanz, Fintan Kelleher
Conformational Studies Of Gram-Negative Bacterial Quorum Sensing 3-Oxo N-Acyl Homoserine Lactone Molecules, Darren Crowe, Alan Nicholson, Adrienne Fleming, Ed Carey, Goar Sanchez-Sanz, Fintan Kelleher
Articles
In their 1H NMR spectra in CDCl3 3-oxo-N-acyl homoserine lactones (OHLs) show significant downfield chemical shifts of the amide N-H proton when compared to the parent N-acyl homoserine lactones (AHLs). NMR spectroscopic and DFT calculation studies have shown that this is most likely due to the presence of a stabilising intramolecular H-bond from the N-H to the 3-oxo group. The 1H NMR spectra also show evidence for the enol tautomers and that the amount of enol present for a range of OHLs is 4.1-4.5% in CDCl3 and 6.5-7.2% in CD3CN. In …
Validation Of A Membrane Touch Biosensor For The Qualitative Detection Of Igg Class Antibodies To Herpes Simplex Virus Type 2, Tony Loughman, Baljit Singh, Brian Seddon, Philip Noone, Padmanabhan Santhosh
Validation Of A Membrane Touch Biosensor For The Qualitative Detection Of Igg Class Antibodies To Herpes Simplex Virus Type 2, Tony Loughman, Baljit Singh, Brian Seddon, Philip Noone, Padmanabhan Santhosh
Articles
A novel type of biosensor was assessed for application to the qualitative determination of circulating antibodies to herpes simplex virus type 2 (HSV-2). The device utilises a high activity HSV-2 type specific gG2 antigen for antibody capture and commercially available ELISA reagents. The study compares the diagnostic performance of a prototype HSV-2 biochip to well-established in vitro tests routinely applied in clinical procedures. A panel of human serum samples (n = 60) previously characterised for HSV-2 serological status using the DiaSorin LIAISON® HSV-2 chemiluminescent immunoassay were assayed on the HSV-2 biochip and the Focus Diagnostics HerpeSelect® 2 ELISA IgG kit …
Biofunctionalized Capillary Flow Channel Platform Integrated With 3d Nanostructured Matrix To Capture Circulating Tumor Cells, Shashwat Banerjee, Ganesh Khutale, Vrushali Khobragade, Narendra Kale, Milind Pore, Govind Chate, Archana Jalota-Badhwar, Manoj Dongare, Jayant Khandare
Biofunctionalized Capillary Flow Channel Platform Integrated With 3d Nanostructured Matrix To Capture Circulating Tumor Cells, Shashwat Banerjee, Ganesh Khutale, Vrushali Khobragade, Narendra Kale, Milind Pore, Govind Chate, Archana Jalota-Badhwar, Manoj Dongare, Jayant Khandare
Articles
Circulating tumor cells (CTCs) from peripheral blood account genetic information for cancer diagnosis and overall disease monitoring. Analysis of “liquid biopsy” holds immense promise as it may lead to new approaches for cancer treatment. The study reports effective and continuous flow microchannel system for isolating CTCs using transferrin conjugated 3D matrix synthesized by crosslinking polyethylene glycol-Fe3O4 nanostructures for rapid and efficient capturing of CTCs. The platform provides option of using multiple microchannel units in series that can influence higher cell-capture efficiency due to increasing cell-substrate contact frequency. CTCs are captured with high efficiency even at low concentration of target cells …