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Computational Drug Discovery and Development Along With Their Applications in the Treatment of Women-Associated Cancers
Published in Shazia Rashid, Ankur Saxena, Sabia Rashid, Latest Advances in Diagnosis and Treatment of Women-Associated Cancers, 2022
Rahul Kumar, Rakesh Kumar, Harsh Goel, Somorjit Singh Ningombam, Pranay Tanwar
Drug development is an extensive process of bringing pharmaceutical active compounds from lab to market and costs more than a billion dollars [3]. In the past few decades, CADD has gained popularity after the successful deliver of the antiviral drug nelfinavir mesylate against HIV protease and anticancer drugs such as axitinib against VEGF kinase domain and crizotinib against c-MET amplification [4–6]. To counter the duration and cost in the journey of drug development, CADD emerges as an effective approach with an overall aim to escalate the development process of drug for clinical testing. CADD is divided into two based on the different methodologies adopted as SBDD and LBDD (Figure 5.1). In this chapter, we have discussed about the strategies involve in the process of target discovery and different approaches in drug development along with their challenges.
Introduction
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow
PDUFA was first enacted in 1992 and authorizes FDA to collect fees from companies that manufacture certain human drugs and biological products in exchange for FDA improving the review process for New Drug Applications (NDAs) and Biologics License Applications (BLAs). The PDUFA authorizes FDA (specifically the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)) to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including post-market drug safety activities.
Clinical Trial Designs
Published in Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson, Bayesian Thinking in Biostatistics, 2021
Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson
One distinguishes clinical studies by their purpose in drug development. The development of pharmaceuticals is traditionally divided into different phases that proceed sequentially. Phase 1 studies seek to learn about toxicity as it relates to dose or schedule. Phase 2 studies generally look for activity, sometimes as a function of dose. Randomized studies that are designed to establish the clinical effectiveness of one therapy over one or several others are phase 3 clinical trials. Phase 3 trials are often the final step in the process of getting regulatory approval for a drug. There are also phase 4 studies that collect data as part of post-marketing surveillance after a drug has received regulatory approval. The goal of such pharmacovigilance is often to collect more information on side effects now that a larger number of people are taking the medication in general clinical settings.
Critical design parameters to develop biomimetic organ-on-a-chip models for the evaluation of the safety and efficacy of nanoparticles
Published in Expert Opinion on Drug Delivery, 2023
Mahmoud Abdelkarim, Luis Perez-Davalos, Yasmin Abdelkader, Amr Abostait, Hagar I. Labouta
New therapies go through a multistep development and approval process to ensure their safety and efficacy. According to the Food and Drug Administration (FDA), the drug development process consists of five stages: discovery and development, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring [1]. In recent decades, this development process has suffered from declining efficiency, as the number of new therapies approved per billion US dollars spent on R&D has halved every 9 years [2]. This declining efficiency in R&D was attributed to several reasons, including the lowering of risk tolerance by regulatory agencies and the tendency toward a higher bar of improvements over existing therapies. The cost of failure also increased, reaching 82% of the cost of developing one new drug in 2004 [3]. Cost of failure is the investment made on candidates that enter clinical trials but do not get approved due to safety or efficacy issues [4].
Repurposing of atorvastatin emulsomes as a topical antifungal agent
Published in Drug Delivery, 2022
Alaa S. Eita, Amna M. A. Makky, Asem Anter, Islam A. Khalil
In the pharmaceutical industry, establishing a new drug is a complicated, costly, and time-consuming process. According to the food and drug administration (FDA), the drug development process generally undergoes four stages before marketing including discovery and development, preclinical, and clinical research. FDA reviews all those stages over 12–15 years (Hughes et al., 2011). A new strategy termed drug repurposing ‘repositioning’ was useful to overcome the lengthy drug discovery process. Repurposing implies the ability to investigate new therapeutic uses for previously approved drugs with different utilization scopes (Pushpakom et al., 2019). Recently, this strategy is widely used effectively in oncology, cardiology, mycology, and other diseases (Peyclit et al., 2021). Many drug classes were investigated for antifungal efficacy, and chosen as useful alternative common drugs (Miró-Canturri et al., 2019; Kim et al., 2020).
One small step in time, one giant leap for DMPK kind – a CRO perspective of the evolving core discipline of drug development
Published in Xenobiotica, 2022
John S. Kendrick, Colin Webber
The emergence of biologics has coincided with a re-focus on anti-cancer drugs (Batta et al. 2020) with a corresponding decline for cardiovascular and neurological drugs, whilst antibiotics and antivirals remained relatively constant until the recent emergence of COVID 19 of course accelerated anti-viral research once more. The latest observation in our own laboratories is of a notable increase in the development of psycho-actives for multiple psychiatric therapeutic applications, which is exemplified by the recent FDA attitude towards the active ingredients from ‘magic mushrooms’ namely psilocybin, DMT and psilocin in the treatment of major depressive disorders (Food and Drug Administration Center for Drug Evaluation and Research 2018; PsychedelicHealth 2022). Drug development is a dynamic and rapidly evolving business and trends associated with the therapeutic area have always been a feature of the industry, sometimes magnified by other factors. Even though it was introduced nearly 40 years ago, the Orphan Drug Act (Code of Federal Regulations 1992) continues to encourage exponential growth in this field, with well over 500 such drugs already approved by the FDA and many more in development. The application of genome editing and stem-cell technologies is enabling researchers to readily create cellular models to enhance their perception of disease processes and drugs that can potentially combat them, expanding the scope of pharmaceutical treatments and accelerating their development.