This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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 clinicaldevelopment 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.
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. Speak with an expert today to discuss your next clinical program. 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. Asia, and Europe.
Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drugdevelopment requires meticulous attention to detail across many clinic and laboratory disciplines.
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
The pharmaceutical industry is under huge pressure to address the high attrition rates in drugdevelopment. With around 90% of candidates failing during clinicaldevelopment, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).
In some cases, the FDA has had to remove approvals of oncology drugs based on single-arm trials after they came to market because confirmatory studies had found that the safety/tolerability profile was less acceptable in the wider population.
In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drugdevelopment. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.
The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.”
The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drugdevelopers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.
As some drugdevelopment organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drugdevelopment industry is undoubtedly in a season of change.
The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.
With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global DrugDevelopment and Chief Medical Officer at Novartis.
In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. is a clinical stage biopharmaceutical company focused on drugdevelopment that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology.
“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global DrugDevelopment and Chief Medical Officer, Novartis. “We
Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.
The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinicaldevelopment process. When should this occur? at the end-of-phase 2 meeting).
EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinicaldevelopment of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinicaldevelopment of anticancer therapeutics in 1996.
Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinicaldevelopment, and their safety and efficacy have not been evaluated by any regulatory authority.
BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drugdevelopment? For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinicaldevelopment.
Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drugdevelopment process as well. As for older adults, differences in product performance for pediatric patients cannot be characterized sufficiently just be adjusting for age or weight.
The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drugdevelopment. To be [administered with] food or not to be?
Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drugdevelopment comes with its own set of clinicaldevelopment requirements. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.
DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety.
estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content