Medicinal-Pharmaceutical Chemistry Commons^™

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 …

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 1^st 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

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.

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

Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland

Level 3

No abstract provided.

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 …

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.

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 )

Level 3

No abstract provided.

Agenda From June 1st Conference

Level 3

No abstract provided.

Speaker Bios

Level 3

No abstract provided.

Links To Prst Past Monographs And Level 3 Special Editions

Level 3

No abstract provided.

Ipq Descriptor

Level 3

No abstract provided.

Ipq Bibliography Pac Km Qrm 2010 - 2023

Level 3

No abstract provided.

Electrospun Ethyl Cellulose Nanofibers With Phase Change Materials: Designing Temperature-Responsive Drug Delivery Systems, Michael Wildy

Theses and Dissertations

In this study, ethyl cellulose (EC) nanofibers loaded with either Rhodamine B (RhB) or Doxorubicin HCl (DOX) and phase change materials (PCM) were fabricated by blend electrospinning. EC is a cellulose derivative widely used as an excipient in the pharmaceutical industry and an ideal polymer for controlled drug release. Lauric acid (LA) and stearic acid (SA) were used as a material with a melting point close to physiological body temperature. Good drug-polymer compatibility and an amorphous distribution of drugs were shown by Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction. The release rate of RhB was shown to …

Electrospun Nanofibers: Shaping The Future Of Controlled And Responsive Drug Delivery., Michael Joshua Wildy, Ping Lu

College of Science & Mathematics Departmental Research

Electrospun nanofibers for drug delivery systems (DDS) introduce a revolutionary means of administering pharmaceuticals, holding promise for both improved drug efficacy and reduced side effects. These biopolymer nanofiber membranes, distinguished by their high surface area-to-volume ratio, biocompatibility, and biodegradability, are ideally suited for pharmaceutical and biomedical applications. One of their standout attributes is the capability to offer the controlled release of the active pharmaceutical ingredient (API), allowing custom-tailored release profiles to address specific diseases and administration routes. Moreover, stimuli-responsive electrospun DDS can adapt to conditions at the drug target, enhancing the precision and selectivity of drug delivery. Such localized API …

An Insight Into The Physicochemical, Drug-Likeness, Pharmacokinetics And Toxicity Profile Of Kigelia Africana (Lam) Bioactive Compounds, Sulyman Olalekan Ibrahim, Halimat Yusuf Lukman, Marili Funmilayo Zubair, Oluwagbemiga Tayo Amusan, Fatimah Ronke Abdulkadri, Bashir Lawal, Lateefat Bello Abdulfatah, Olubunmi Atolani

Al-Bahir

Kigelia africana plant is multipurpose plant whose therapeutic potential has been thoroughly investigated. The physicochemical, solubilities, ADMET, pharmacological, and drug-like properties of this plant have not been reported in details. This study makes use of the information that is currently known on the chemical make-up of the plant to forecast its overall toxicity as well as the potential for the phytochemicals it contains to be employed in medication discovery. The study also employed free web servers for the lipophilicity, water solubility, drug-likness, bioavailability score, medicinal chemistry and toxicological profiling of the compounds of K. africana. Artemether, a known antimalaria …

Postsynthetic Modification Of The Nonanuclear Node In A Zirconium Metal−Organic Framework For Photocatalytic Oxidation Of Hydrocarbons, Rebecca Shu Hui Khoo, Christian Fiankor, Sizhuo Yang, Wenhui Hu, Chongqing Yang, Jingzhi Lu, Martha D. Morton, Xu Zhang, Yi Liu, Jier Huang, Jian Zhang

Department of Chemistry: Faculty Publications

Heterogeneous catalysis plays an indispensable role in chemical production and energy conversion. Incorporation of transition metals into metal oxides and zeolites is a common strategy to fine-tune the activity and selectivity of the resulting solid catalysts, as either the active center or promotor. Studying the underlying mechanism is however challenging. Decorating the metal-oxo clusters with transition metals in metal−organic frameworks (MOFs) via postsynthetic modification offers a rational approach to construct well-defined structural models for better understanding of the reaction mechanism. Therefore, it is important to expand the materials scope beyond the currently widely studied zirconium MOFs consisting of Zr_{6 …}

Machine Learning‑Assisted Low‑Dimensional Electrocatalysts Design For Hydrogen Evolution Reaction, Jin Li, Naiteng Wu, Jian Zhang, Hong‑Hui Wu, Kunming Pan, Yingxue Wang, Guilong Liu, Xianming Liu, Zhenpeng Yao, Qiaobao Zhang

Department of Chemistry: Faculty Publications

Efficient electrocatalysts are crucial for hydrogen generation from electrolyzing water. Nevertheless, the conventional "trial and error" method for producing advanced electrocatalysts is not only cost-ineffective but also time-consuming and labor-intensive. Fortunately, the advancement of machine learning brings new opportunities for electrocatalysts discovery and design. By analyzing experimental and theoretical data, machine learning can effectively predict their hydrogen evolution reaction (HER) performance. This review summarizes recent developments in machine learning for low-dimensional electrocatalysts, including zero-dimension nanoparticles and nanoclusters, one-dimensional nanotubes and nanowires, two-dimensional nanosheets, as well as other electrocatalysts. In particular, the effects of descriptors and algorithms on screening low-dimensional electrocatalysts …

Molecularly Imprinted Electrochemical Sensor Based On Poly (O-Phenylenediamine) For Sensitive Detection Of Oxycodone In Water, Pranaya Charkravarthula, Amos Mugweru

College of Science & Mathematics Departmental Research

This work was aimed at the development of a sensitive electrochemical detection method for oxycodone in water. Molecularly imprinted electrodes were formed by electro-polymerization process using o-phenylenediamine as a monomer. The electro-polymerization was performed on glassy carbon electrodes in the presence of oxycodone before the extraction of entrapped oxycodone molecules. Various electrochemical techniques were employed to monitor the polymerization and response of the fabricated electrodes toward oxycodone. These techniques included cyclic voltammetry (CV), square wave voltammetry (SWV), differential pulse voltammetry (DPV) and electrochemical impedance spectroscopy (EIS). The oxycodone concentration was determined using SWV by measuring the change in the oxidation …