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The review provides a comprehensive analysis of non-hydroxamate inhibitors for IspC, an enzyme crucial in the MEP pathway, highlighting its structural diversity and improved drugdevelopment potential. This has led to increased interest in non-hydroxamate inhibitors.
Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs).
The regulatory environment in Japan for generic drugdevelopment is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. This can result in failed runs and wasted reagents.
Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?
Generic drugdevelopment is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.
Sujeegar Jeevanandam, an expert with 13 years of experience in life sciences R&D, offers valuable insights into the current state and future trajectory of artificial intelligence in drug discovery. This breakthrough could fundamentally change how drugs are developed and tested.
The objective of this study was to examine the in vitro metabolic stability of panobinostat in different matrices and assess the influence of that metabolic stability on the in vivo pharmacokinetics and CNS delivery of panobinostat.
Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drugdevelopment lifecycle.
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Trial design and statistical methods are also key to determining the utility and validity of biomarkers.
Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity. This study aimed to develop a translational PK-TD model using rat data to inform dosing strategies and TD implications in humans.
Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Many drugs fail because they simply aren’t safe. Seal began this work after wondering if more toxicology insights could be gleaned from a drug candidate’s chemical structure.
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. Conventional models often fail to predict cardiac side effects, especially with biologics.
Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.
Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.
Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Toxicological investigations play a key role in assessing drug safety and, importantly, inform development decisions.
During the drugdevelopment process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.
In this blog, we explain the role of clinical pharmacology in drugdevelopment and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.
Here at DrugBank, we understand the critical importance of addressing drug safety and toxicity early in development. Developing a new therapeutic is a complex and high-stakes process, often spanning over a decade and requiring investments that exceed billions of dollars. However, these traditional approaches have limitations.
Furthermore, we evaluated the in vivo pharmacokinetics of the analogs following single dose IV and oral administration. Surprisingly, and at odds with their pharmacokinetic and in vitro human activity data, most analogs potently induced uterotrophic effects in estrogen-naïve female mice.
MENU logo-altasciences EN - Main navigation Proactive DrugDevelopment Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Salt Lake City Salt Lake City Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:11 Image Downtown (..)
This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.
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Metabolic DrugDevelopment: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drugdevelopment, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.
Accelerating Global DrugDevelopment Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. In this complimentary webinar , Mel B. Watch the webinar.
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
First, we assessed the substrate potential of riboflavin towards other major drug transporters using established transfected cell systems. Overall, these data indicate that plasma riboflavin is a promising biomarker of BCRP that may offer a possibility to assess drug candidate as a BCRP modulator in early drugdevelopment.
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drugdevelopment.
Assays des cribe the experimental set-up when testing the activity of drug-like compounds against biological targets; they provide useful context for researchers interested in drug-target relationships. On the other hand, the drug concentration and route of administration are more relevant for the interpretation of ADMET assays.
Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. “The classic paradigm with todays psychiatry drugs involves patients chronically taking a daily medication,” says Donello.
MENU logo-altasciences EN - Main navigation Proactive DrugDevelopment Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution Business Leaders (..)
The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.
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The pharmaceutical industry is under huge pressure to address the high attrition rates in drugdevelopment. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. When imaged, the hiPSC showed a stable beating rate.
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On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.
While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway.
puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.
We have since leveraged our Platform to develop two candidate drugs; MB310 for treatment of ulcerative colitis and MB097 which is intended for use alongside immune-checkpoint inhibitors (ICIs) in melanoma patients to boost their responsiveness to the ICIs. How does it work and what are the potential benefits?
The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drugdevelopment. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.
Epigenetic drugs, which target the enzymes and processes involved in these modifications, represent a novel approach to precision medicine. Understanding these processes is critical for developing effective epigenetic therapies. Delivering epigenetic drugs to specific tissues remains a significant obstacle.
Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drugdevelopment. With “specialized for peptide” drug metabolism and pharmacokinetics (DMPK) and biological evaluation, we’re able to solve certain synthesis issues found across different cyclic peptides, complexes peptides and mimetic peptides.
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