Drug Patent Watch

JANUARY 14, 2025

.”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

Drug Development 67

Drug Development Drugs FDA Production 67

DrugBank

OCTOBER 17, 2024

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 drug development lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.

Drug Development 98

Drug Development Metabolic Stability Clinical Trials Drugs 98

ASPET

JULY 15, 2024

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.

Pharmacokinetics 100

Pharmacokinetics Drugs Therapies Treatment 100

Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Drug Target Review

MARCH 24, 2025

Promising areas for AI implementation When discussing the most transformative AI applications in drug discovery, Sujeegar identifies a particularly ambitious goal: developing AI models that can simulate human pharmacokinetics and pharmacodynamics (PK/PD) using only preliminary laboratory data.

Clinical Trials 59

Clinical Trials Animal Testing Drugs Pharmacokinetics 59

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.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Trials 52

Broad Institute

JULY 17, 2024

Srijit Seal, a visiting scholar at the Carpenter-Singh Lab in the Broad's Imaging Platform , trained multiple predictive machine learning models to identify chemical and structural drug features likely to cause toxic effects in humans. Pharmacokinetic modeling is difficult, time-consuming, and requires expensive instruments and software.

Pharmacokinetics 124

Pharmacokinetics Molecular Biology Drugs FDA 124

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

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.

Pharmacokinetics 100

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.

Clinical Trials 98

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.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

DrugBank

APRIL 3, 2025

Advances in predictive modeling, high-throughput screening, and omics technologies have provided powerful tools to uncover safety risks early in the drug development pipeline. Addressing safety issues early in the pipeline is essential to improving efficiency and reducing the risks associated with development.

Drug Development 52

Drug Development Drugs Clinical Trials Pharmacokinetics 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.

Drug Development 40

Drug Development Clinical Trials Drugs Pharmacokinetics 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. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

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

Pharmacogenetics 100

Pharmacogenetics Pharmacokinetics Drug Development Drugs 100

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 Drugs FDA Approval 52

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.

International 52

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.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Drug Target Review

JUNE 16, 2025

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. This article explores the principles, applications and future potential of MSI in drug development.

Drugs 52

Drugs Organic Chemistry Laboratories Pharmaceuticals 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.

Pharmacokinetics 125

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.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 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.

Pharmacokinetics 105

Pharmacokinetics International Laboratories Drugs 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

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 Drug Development Science Clinical Trials 52

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

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!

Production 40

Production Pharmacokinetics Drug Development Drugs 40

Drug Target Review

MARCH 17, 2025

This is based on the traditional model of occupancy-driven pharmacology, where a drug’s therapeutic effects are directly related to the time it occupies its target. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

Treatment 52

Treatment Licensing Licensing Science 52

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.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 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. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

Drugs 52

Drugs FDA Approval Pharmacokinetics 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.,

Drugs 52

Drugs Pharmacokinetics 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.

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Production 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).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

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

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.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

DrugBank

APRIL 24, 2025

Challenges in Epigenetic Drug Development Achieving specificity is a primary challenge in epigenetic drug development. How DrugBank Supports Epigenetic Drug Discovery Here at DrugBank, we are proud to support researchers in advancing the discovery and development of epigenetic therapies.

DNA 52

DNA Drugs Therapies Regulations 52