Drug Target Review

JUNE 19, 2025

South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. From bench to bedside: what is next? SRP-001 has already moved beyond the laboratory.

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Drug Target Review

DECEMBER 4, 2024

What are the primary considerations in optimising the pharmacokinetics (PK) and biodistribution of MC4R-specific nanobodies in preclinical obesity models, and how does Confo Therapeutics plan to address challenges related to blood-brain barrier penetration?

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Elrig

MARCH 25, 2025

At AstraZeneca, Dr Shalini Andersson is Vice President Nucleic Acid Therapeutics in Discovery Sciences and Chief Scientist New Therapeutic Modalities in BioPharmaceuticals R&D.

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The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes. With successful launches already underway in the U.S.

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New Drug Approvals

JULY 25, 2025

16] Population pharmacokinetics (PK) of vamorolone was shown to fit to a 1-compartment model with zero-order absorption, with both adult men and young boys showing dose-linearity of PK parameters for the doses examined, and no accumulation of the drug during daily dosing. . mg/kg/day suggesting benefit. [15] 117 (39): 24285–24293.

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Drug Target Review

MARCH 17, 2025

Previously, he served as VP of Science & External Innovation at Allergan, where he played a pivotal role in the global development of zelquistinel, a third-generation oral N-methyl-D-aspartate (NMDA) receptor modulator. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

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The Pharma Data

JULY 3, 2025

Biosynth Unveils Expanded GMP Bioconjugation Facility in Berlin to Advance Next-Generation Therapeutics Biosynth, a global leader in providing essential raw materials and services for the life sciences and diagnostics industries, has officially inaugurated a major expansion of its GMP bioconjugation facility in Berlin. source link

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PPD

APRIL 14, 2025

To that end, the PI can ensure patients understand the science of appetite and metabolic regulation, for example, to relieve some of the self-imposed expectations for instant weight loss or other quick signs of success. Whatever the reason behind a patients fatigue, education and encouragement are key to continued engagement.

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Drug Patent Watch

JANUARY 14, 2025

In the world of generic drugs, we have something even better: Physiologically Based Pharmacokinetic Modeling (PBPK). Regulatory Evolution As the science evolves, so too must the regulatory landscape. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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New Drug Approvals

JULY 18, 2025

. “Quantification of 2′-deoxy-2′-β-fluoro-4′-azidocytidine in rat and dog plasma using liquid chromatography-quadrupole time-of-flight and liquid chromatography-triple quadrupole mass spectrometry: Application to bioavailability and pharmacokinetic studies” Journal of Pharmaceutical and Biomedical Analysis.

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RNA Clinical Trials Trials Virus 62

Broad Institute

JULY 17, 2024

Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function. Drug developers also assess pharmacokinetic effects, or how an organism absorbs, distributes, metabolizes, and clears a drug. Papers cited Seal S, et al.

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Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. The Science Behind Generic Drug Development. For instance, the U.S. ” References : BioPharma Services.

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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. These complex molecules require precise engineering to ensure optimal efficacy and safety.

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch it now. The Altascientist : Issue No.

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Drug Target Review

DECEMBER 12, 2023

We use hydrophilic linkers, which prevent ADC aggregation and generate highly stable ADCs, in combination with a unique attachment site on the antibody to create ADCs that retain pharmacokinetic properties similar to the original unconjugated antibody. This helps to maximize the targeted payload delivery to tumor cells.

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The ChEMBL-og

DECEMBER 13, 2023

Credit: Science biotech, CC BY-SA 4.0 ADME (type A) and toxicity (type T) assays Pharmacokinetic studies provide an insight into the action and processing of a drug in vivo. Ver sion 33 of ChEMBL contains 1.6 million diverse assays spanning ADMET, physicochemical, binding, functional and toxicity experiments. A physicochemical assay.

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Drug Target Review

APRIL 22, 2024

Despite excellent pharmacokinetic and stable antibody-linker connections, such ADCs have yet to receive market approval. How do the selection of linkers and conjugation sites impact the pharmacokinetics and therapeutic window of an ADC?

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PPD

JULY 29, 2024

Artificial Intelligence (AI) imitates human cognitive functions using computer science, algorithms, machine learning and data sciences. AI has the capability to analyze and forecast the pharmacokinetic (PK) profiles of drugs following their administration.

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Drug Target Review

SEPTEMBER 19, 2023

The organoid technology recreates different disease scenarios in addition to the healthy models with age specific phenotypes and enables recreating drug specific Pharmacokinetics that is more relevant to human in vivo system. Closing remarks Solution based science, but not problem-based science becomes the basis of success of science.

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Sygnature Discovery

JANUARY 26, 2024

Working closely with our colleagues in Process Chemistry and Scale-Up, Drug Metabolism and Pharmacokinetics (DMPK), Pharmacology, and Separation Science, we can apply the right tools to solve the most complex challenges in your project. This approach helps to overcome even the most complex bioavailability or stability challenges.

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Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. Following that realization, I switched my goals to science, biology, and health, and started down my current career path. What advice would you give to someone just starting out in life sciences?

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thought leadership

DECEMBER 10, 2024

The pharmacokinetic (PK) principles of this guideline are generally applicable to other orally and non-orally administered drug products in which reliance on systemic exposure measures is suitable for establishing BE, e.g., certain rectal, inhalation, and nasal drug products.

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Drug Target Review

OCTOBER 24, 2023

What is the specific focus of the drug that Microbiotica is advancing for the treatment of ulcerative colitis, and how does it leverage microbiome science to address this medical condition? MB310 is a consortium of nine bacterial species for treatment of mild to moderate ulcerative colitis.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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The Pharma Data

MARCH 25, 2022

Maximizing potential of traditional medicines through modern science and technology. Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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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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DrugBank

APRIL 3, 2025

These studies typically include in vitro assays to evaluate cytotoxicity and in vivo models to study pharmacokinetics, pharmacodynamics, and toxicological profiles. These models are further enhanced by integrating data from DrugBank, which provides annotations of drug metabolism and pharmacokinetics.

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Drug Target Review

SEPTEMBER 25, 2024

A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. Science Advances [Internet]. Available from: [link] 8.Boni Boni V, Garralda E, Colombo I, Krisztian Homicsko, Brana I, Gruber D, et al. Available from: [link] 9.Mohanty

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LifeSciVC

OCTOBER 10, 2024

To that end, our Phase 1 monotherapy data hit the mark and showed early evidence of precisely what we were looking for: A dose-dependent pharmacokinetic profile that achieved target exposures at dose levels that were well-tolerated by patients.

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Agency IQ

FEBRUARY 23, 2024

. … And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

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Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients. Journal of Nuclear Medicine. 2016 May 26;57(10):1505–11.

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Agency IQ

AUGUST 9, 2024

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.

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Agency IQ

MAY 17, 2024

For the in vivo portion, the guidance states that applicants should conduct: 1) An in vivo pharmacokinetics (PK) study in fasting condition for both product strengths with healthy volunteers, and 2) an in vivo comparative clinical endpoint or pharmacodynamic (PD) study with patients.”

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The Pharma Data

MARCH 22, 2021

GEN-PEAK: a Phase I study aiming to better understand the pharmacokinetics of tominersen and how tominersen affects mHTT levels and other markers in the spinal fluid and blood, which studies a range of doses from 30 mg to 120 mg of tominersen over two administrations. About Roche in Neuroscience.

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Disease Clinical Trials Pharmacokinetics Treatment 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. Tags Science and Health About Altasciences Weight 1

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The Pharma Data

MARCH 13, 2021

Advancing the science is crucial to the way we operate and we are unafraid to push at the boundaries of success in our mission to accelerate diagnosis and develop transformative and sustainable treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.

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