ASPET

JUNE 27, 2024

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.

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Pharmacokinetics Drug Development Disease Drugs 100

PPD

SEPTEMBER 19, 2023

During the drug development 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.

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Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development 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.

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Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Drug Target Review

DECEMBER 11, 2024

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.

International 52

International Laboratories Drugs Pharmacokinetics 52

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.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

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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Drug Development Clinical Trials Pharmacokinetics Drugs 40

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. In this complimentary webinar , Mel B. Watch the webinar.

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Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

ASPET

JANUARY 31, 2024

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 drug development.

Pharmacogenetics 100

Pharmacogenetics Pharmacokinetics Drug Development Drugs 100

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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Clinical Research Clinical Trials Research Trials 98

The ChEMBL-og

DECEMBER 13, 2023

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.

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Pharmacokinetics Drugs Drug Development Science 125

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

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Clinical Trials Trials Pharmacokinetics Small Molecule 52

BMG Labtech

MARCH 11, 2024

They are often the method of choice to detect or measure specific biological molecules (analytes) for diagnostics, drug discovery or fundamental research. This type of application helps guide the development and optimization of therapeutics. Quality control is therefore another area that benefits from ELISA measurements.

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Vaccine Molecular Biology Laboratories Virus 98

Drug Target Review

NOVEMBER 15, 2023

Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.

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Pharmacokinetics International Laboratories Drugs 105

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. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

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Packaging Pharmacokinetics Small Molecule Clinical Trials 52

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. When imaged, the hiPSC showed a stable beating rate.

Drugs 52

Drugs FDA Approval Pharmacokinetics Drug Development 52

The Premier Consulting Blog

AUGUST 8, 2024

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.

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Pharmacokinetics Drugs FDA Production 52

Drug Target Review

SEPTEMBER 25, 2024

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.

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Small Molecule Therapies Regulations Treatment 105

Fierce BioTech

MAY 1, 2024

Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drug development. 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.

Pharmacokinetics 52

Pharmacokinetics Drug Development Drugs 52

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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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

OCTOBER 24, 2023

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?

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Treatment Pharmacokinetics Pharmaceuticals Trials 122

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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Pharmacokinetics Clinical Trials Drug Development Science 52

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. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Animal Testing Biosimilars Cell Based Assays FDA 64

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. As we step into 2024, the momentum is expected to continue, with analysts projecting the weight loss drug market to reach remarkable heights, potentially hitting $100 billion by the end of the decade.

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Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 80

Alta Sciences

AUGUST 7, 2023

We perform ocular pharmacokinetic studies in multiple species (rodent and non-rodent), using different types of formulations and routes of administration, and support study durations ranging from single-dose acute to studies of six and nine months. Let’s get you started!

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Production Pharmacokinetics Drug Development Drugs 40

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

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Drugs Clinical Pharmacology Packaging Small Molecule 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

If two or more doses are discovered to have comparable efficacy, the lowest effective dose should be used in the registration trial to help minimize the toxicity effects when the drug is used in a broader heterogeneous patient population. Platform Trial: Incorporates multiple drugs and/or different tumor types in various study arms.

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Clinical Trials Trials Pharmacokinetics FDA 83

Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.

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Small Molecule FDA Approval FDA Pharmacokinetics 59

Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study.

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Trials Treatment Clinical Pharmacology Pharmacokinetics 40

The Premier Consulting Blog

APRIL 15, 2024

By William Salminen , Madelyn Huang, & Andrew Emanuel Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. neurotoxicity) that require special assessments.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Drug Target Review

OCTOBER 16, 2024

My clinical background as a physician led me to drug development, where I realised I could have an even broader impact on patient well-being. Both research efforts resulted in the creation of new drugs. 1,2 Moments like these, where we bring new mechanisms through clinical testing, reaffirm my commitment to drug development.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

Drug Target Review

JULY 12, 2023

The clinical-stage oncology company develops medicines for broad populations of cancer patients and aims to achieve universal-RAS activity through deep cyclic inhibition of the mitogen-activated protein kinase (MAPK) pathway, selectively impacting cancer cells while sparing healthy cells.

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Biochemical Assays Treatment Bioinformatics Disease 98

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

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Clinical Trials Treatment Trials Drug Development 52

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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Marketing FDA Regulations Pharmacokinetics 59

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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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

Alta Sciences

AUGUST 21, 2023

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Why Partner With Altasciences for Your Bioanalytical Projects?

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Assay Development Pharmacokinetics Drug Development Drugs 52