Alta Sciences

JANUARY 31, 2024

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.

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Pharmacokinetics Clinical Trials Drug Development Trials 52

Broad Institute

JULY 17, 2024

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. Drug developers also assess pharmacokinetic effects, or how an organism absorbs, distributes, metabolizes, and clears a drug.

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PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

PPD

JULY 29, 2024

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 drug development.

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DrugBank

APRIL 3, 2025

Developing a new therapeutic is a complex and high-stakes process, often spanning over a decade and requiring investments that exceed billions of dollars. Despite this significant commitment of time and resources, many drug candidates fail in clinical trials, with safety and toxicity concerns being one of the leading causes.

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Alta Sciences

AUGUST 12, 2024

Metabolic Drug Development: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.

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The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

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Clinical Trials Vaccine Trials Medical Schools 52

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development 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.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

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DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage.

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Drug Target Review

SEPTEMBER 19, 2023

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.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Read the fact sheet. Watch it now.

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Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacokinetics Pharmacokinetics examines the absorption, distribution, metabolism, and excretion properties of a drug.

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Packaging Pharmacokinetics Small Molecule Clinical Trials 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. “Thus far, CRV431 appears well-tolerated in patients.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” The post Trends in Oncology Study Design, from Optimus to Endpoints appeared first on Worldwide Clinical Trials.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers 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.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ).

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Animal Testing Biosimilars Cell Based Assays FDA 64

Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. What Was your dream job as a child?

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Drug Target Review

OCTOBER 24, 2023

We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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Drugs FDA Approval Pharmacokinetics Drug Development 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. 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.

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Licensing Licensing Pharmacokinetics Clinical Trials 52

The Premier Consulting Blog

APRIL 15, 2024

From a business standpoint, these studies are critical for obtaining funding and being reassured that the drug will show promise once it enters the clinic. However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety.

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The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The study will be conducted in South Africa. President and Chief Executive Officer of SCYNEXIS. For more information, visit www.scynexis.com.

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Hospitals Pharmacokinetics Treatment Trials 52

DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.

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Cell Based Assays Drugs Pharmacokinetics Disease 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Aticaprant is taken by mouth. [1] nM vs. 24.0 nM vs. 24.0

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The Pharma Data

OCTOBER 18, 2020

The 450mg starting dose in AML patients was selected because that dose, when administered to CLL patients being treated in a separate Phase 1 a/b trial, appeared safe, well tolerated and achieved plasma exposure levels that effectively inhibited phospho-FLT3 activity, which is a key driver of AML.”. Forward Looking Statements.

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The Pharma Data

AUGUST 30, 2021

These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. Dupilumab Development Program. Further, 81% of these patients had at least one concurrent type 2 inflammatory disease.

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Agency IQ

DECEMBER 11, 2023

This guidance joined others in the FDA’s catalog that focus on diversity in research, including its 2022 guidance on inclusion of older adults in cancer clinical trials and its November 2020 guidance on “ Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”

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The Pharma Data

AUGUST 29, 2020

“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 Drug Development and Chief Medical Officer, Novartis. “We

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The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. The Company also plans to initiate a Phase 2 trial in hospitalized patients suffering from agitation associated with delirium within the next several months. BioXcel Therapeutics, Inc.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 5, 2020

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 clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. Participant fatigue in GLP-1 clinical trials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.

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Clinical Trials Trials Clinical Development Disease 52

Alta Sciences

DECEMBER 31, 2024

Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drug development (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.

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