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Biogenic Nanoparticles Based Drugs Derived from Medicinal Plants
Published in Richard L. K. Glover, Daniel Nyanganyura, Rofhiwa Bridget Mulaudzi, Maluta Steven Mufamadi, Green Synthesis in Nanomedicine and Human Health, 2021
Charles Oluwaseun Adetunji, Olugbenga Samuel Michael, Wilson Nwankwo, Osikemekha Anthony Anani, Juliana Bunmi Adetunji, Akinola Samson Olayinka, Muhammad Akram
Bioinformatics plays a major role in rational drug design, thus reducing the time and cost of drug development. The foregoing is true in the synthesis of drugs as bioinformatics provides comprehensive analytical tools and huge databases for modelling of proteins, genes and related biological compounds as well as the evaluation of the interaction and behaviour, including compatibility and functionalities. In other words, it provides a very cost-effective in silico environment for simulating, verifying and validating the behaviour of drug and drug-related compounds in biological systems.
Investment Dynamics in the World of Pharma
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
The US public could be characterized as wanting a free magic pill that cures its problems, but with no risks or associated side effects, a hurdle that is virtually impossible to meet. The symptoms of these unrealistic societal expectations are unwarranted tort litigations, special interest agendas, the devastating opioid epidemic, and displeasure as drug prices continue to increase, just to name a few. These societal expectations have resulted in the FDA taking the stance that their primary objective is to protect patients. This mindset has two major impacts on the drug development process: first, the human side of the FDA is likely to take the most conservative position on areas of “grey” by requiring more data, which is time-consuming and increases the expenses associated with the program and therefore negatively impacts an NPV calculation. The current increase in cost of drug development noted above is a direct response of the FDA trying to respond to societal insistence on relatively few side effects. Second, if a drug developer is not sure exactly how a specific aspect of the program will be viewed in the context of the current regulatory guidelines, they must file a formal request for information. This is time-consuming and can result in either unclear or non-committal advice.
Fundamental Principles of Clinical Trials
Published in Demissie Alemayehu, Birol Emir, Michael Gaffney, Interface between Regulation and Statistics in Drug Development, 2020
Demissie Alemayehu, Birol Emir, Michael Gaffney
With the ever-rising cost of drug development, prolonged development time, and dwindling number of new medicines achieving marketing authorization, there has been increased focus on novel approaches to clinical development and trial design. This has particularly been the centerpiece of the Food and Drug Administration’s (FDA) Critical Path Initiative, launched with the aim of improving efficiency and reducing attrition rates. Proposed approaches under that framework include use of historical data, modeling and simulation, and trial designs, such as the seamless Phase II/III trials, having greater degrees of flexibility than those employed traditionally. Although these novel approaches have tremendous potential to generate reliable information in a speedy manner, their implementation may require substantial quantitative work and operational efforts. Consequently, while there are cases of successful applications, routine use of the approaches has not yet been fully realized. In the traditional paradigm, the efficacy of the drug in the targeted population along with the manner in which it can be safely administered should be established at the end of Phase III. The drug developer then submits the entire body of research in a New Drug Application (NDA) to the regulatory agencies.
The mechanisms of Huangqi Guizhi Wuwu decoction in treating ischaemic stroke based on network pharmacology and experiment verification
Published in Pharmaceutical Biology, 2023
Weiguo Liao, Minchun Wang, Ying Wu, Jinyan Du, Yaxin Li, Anyu Su, Lanying Zhong, Zi Xie, Mingyu Gong, Junhui Liang, Pengcheng Wang, Zai Liu, Lisheng Wang
Because of major advances in bioinformatics and poly-pharmacology, network-based drug discovery is now considered as a feasible strategy for cost-effective drug development (Shen et al. 2020). Network pharmacology is an approach to examine formulation processes in vivo, comprehend formulation-disease relationships, and assist experimental studies (Boezio et al. 2017). According to TCM’s holistic viewpoint, it explores the molecular mechanism of formulation by utilizing a “disease-target-herb” network model (Kibble et al. 2015; Xu et al. 2021). It involves creating a “compound-target-pathway” network to assess the influence of bioactive substances and targets. Applying network pharmacology to find the key targets for ischaemic stroke is a good strategy. (Wang et al. 2022). The present research employs a network informatics technique to analyse the mechanisms of HGWD against IS and prove its effectiveness as a treatment for IS.
Drug development post COVID-19 pandemic: toward a better system to meet current and future global health challenges
Published in Expert Opinion on Drug Discovery, 2021
Koippallil Gopalakrishnan Aghila Rani, Mohamad A. Hamad, Dana M. Zaher, Scott McN Sieburth, Navid Madani, Taleb H. Al-Tel
The amount spent to develop an individual drug largely depends on the costs to conduct safety and efficacy studies and also to secure regulatory approvals. Estimates for the cost for Drug development range from ~ 1 billion to whopping 11.8 billion for a single drug [27,28]. However, around 90% of drugs in development for human use do not reach the market due to safety or efficacy concerns. Such failures can be due to lack of efficacy, safety issues, or a lack of funding to complete a trial [29]. In other cases, failing to maintain good manufacturing protocols and follow FDA guidance, as well as problems with patient recruitment, enrollment, retention and follow up can all compound to both complicate and increase the cost needed for drug development [29]. Given this mounting cost with little success due to high attrition rates, it is obvious that the drug development as a business model is very risky purely from an economical and financial sense. Aside from the high cost/high attrition rates nature of the drug discovery process, other drugs, like antibiotics or orphan drugs, are often abandoned and don’t reach the market due to little or no commercial interest [30].
Disease-modifying drugs in osteoarthritis: current understanding and future therapeutics
Published in Expert Opinion on Emerging Drugs, 2018
Win Min Oo, Shirley Pei-Chun Yu, Matthew Sean Daniel, David John Hunter
Pharmaceutical research and drug development in OA can be entangled with challenges, such as lack of meeting regulatory criteria and absence of sensitive biomarkers. The cost of drug development (to take a drug from discovery through to completing phase 3 trials) is concerning [34], with an estimated 9-fold increase from US$92 million in 1979 to US$883.6 million in 2010 in the 2009 US dollars [35]. In a cost-effectiveness analysis model of DMOADs interrogating what the likely threshold for cost-effectiveness would be, base-case DMOADs added 4.0 quality-adjusted life years (QALYs) and $230,000 per 100 persons, with incremental cost-effectiveness ratios (ICER) of $57,500/QALY. DMOADs reduced the need for total knee replacements by 15%. Drug cost, quantity of reduced progression of disease, and pain relief are key drivers of cost-effectiveness. DMOADs costing $3,000/year achieved ICERs below the $100,000/QALY if the likelihoods of reduced progression and pain relief were 20% and 70%. At a cost of $5,000, these ICERs were attained if the likelihoods of suspended progression and pain relief were both 60% [36]. It is important for DMOAD developers to factor these thresholds in when considering the development of products.