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. 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

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

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

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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Drug Development Treatment FDA Approval Drugs 52

ASPET

JANUARY 31, 2024

The effects of BMS-986371, a potent in vitro inhibitor of BCRP ( IC 50 0.40 µM), on the pharmacokinetics of riboflavin, isobutyryl carnitine, and arginine were then examined in healthy male adults (N = 14 or 16) following oral administration of methotrexate (MTX) (7.5

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Pharmacogenetics Pharmacokinetics Drug Development Drugs 100

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. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

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Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

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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International Laboratories Drugs Pharmacokinetics 52

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

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.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

The ChEMBL-og

DECEMBER 13, 2023

ADME (type A) and toxicity (type T) assays Pharmacokinetic studies provide an insight into the action and processing of a drug in vivo. Furthermore, publication of late-stage animal toxicity assays can provide an insight into the mechanism of drug toxicity. A physicochemical assay.

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Pharmacokinetics Drugs Drug Development Science 125

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

BMG Labtech

MARCH 11, 2024

In drug development and discovery, ELISAs are useful to quantify drug concentrations in biological samples where they find applications in studies of drug efficacy, pharmacokinetics, and pharmacodynamics. This type of application helps guide the development and optimization of therapeutics.

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Vaccine Molecular Biology Laboratories Virus 98

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

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

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?

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 52

Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet]. Available from: [link] 9.Mohanty

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

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

Drug Target Review

SEPTEMBER 19, 2023

In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures. Miniature organs as test beds for new drugs Organoids are miniature human organs with clusters of cells derived from stem cells and mimic specific tissues.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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).

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,

Pharmacokinetics 52

Pharmacokinetics Drugs FDA Production 52

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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Treatment Pharmacokinetics Pharmaceuticals Trials 122

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Animal Testing Biosimilars Cell Based Assays FDA 64

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. To learn more about Altasciences, visit altasciences.com.

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Trials Treatment Clinical Pharmacology Pharmacokinetics 40

DrugBank

MARCH 7, 2024

Moreover, smaller companies like Altimmune are seeking partnerships to propel the development of their experimental drugs. As larger players scout for innovative solutions, partnerships with smaller firms offer a pathway to accelerate drug development and diversify product portfolios.

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Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 80

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. 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

The Premier Consulting Blog

APRIL 15, 2024

For example, a new fixed dose combination product using two FDA-approved active pharmaceutical ingredients (APIs) may benefit from a preliminary drug-drug interaction (DDI) screen to rule out possible pharmacokinetic (PK) interactions and facilitate a more informed discussion with the FDA regarding the necessity of GLP combination toxicity studies.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Drug Target Review

OCTOBER 3, 2024

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 drug development. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Metabolite Tales Blog

APRIL 10, 2024

Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. [link] [9] Multi-disciplinary Review and Evaluation for NDA 215830 Litfulo (ritlecitinib) capsule. link] [10] Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. 2023; 62(12):1765-1779.

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Small Molecule FDA Approval FDA Pharmacokinetics 59

Conversations in Drug Development Trends

DECEMBER 20, 2023

Biomarker Endpoints Biomarker endpoints are another helpful way to assess the potential efficacy of both initial dose-finding studies and dose-optimization studies.

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Clinical Trials Trials Pharmacokinetics FDA 83

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

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.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

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.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

PPD

JUNE 20, 2023

As some drug development 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 drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

The Pharma Data

DECEMBER 14, 2020

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. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.

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Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

SEPTEMBER 7, 2021

Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey.

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Clinical Trials Vaccine Trials Medical Schools 52

The Pharma Data

DECEMBER 9, 2020

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.

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Hospitals Pharmacokinetics Treatment Trials 52