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.

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PPD

OCTOBER 12, 2023

Parallels between pharmacokinetic (PK) analyses for CGTs and immunotherapies, conducted through PCR-based assays and plate-bound antibody assays, respectively, can inform a successful approach. However, key differences between PCR assays and immunotherapeutic assays must be considered.

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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Advarra

JUNE 20, 2023

Enrollment barriers may affect: Protocol/design factors Oncology clinical trials often have complex trial design due to their advanced precision medicine treatments. Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements.

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Trials Clinical Trials FDA Approval Therapies 52

Drug Target Review

OCTOBER 16, 2024

In reality, our deep understanding of disease pathology and patient needs is instrumental in shaping both basic and clinical research into viable treatments. Interestingly, to these days, there is still the misconception that physicians’ roles are limited to direct patient care.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 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. Does your CRO look after your most valuable resources?

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Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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Clinical Trials Compliance Trials Laboratories 52

The Anticancer Fund

APRIL 1, 2022

This randomised controlled phase I/II trial assessed the safety, pharmacokinetic impact, and efficacy of the GR antagonist mifepristone (Mif) in combination with enzalutamide vs enzalutamide alone for CRPC. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund.

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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Drugs Clinical Trials Trials Treatment 40

Agency IQ

AUGUST 11, 2023

These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

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FDA Compliance Clinical Trials Pharmacokinetics 40

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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The Pharma Data

SEPTEMBER 1, 2021

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva*, M.D., DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science 40

Science FDA Production Trials 40

Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies 52

Therapies Pharmacokinetics Pharmacogenetics Clinical Trials 52

The Pharma Data

AUGUST 9, 2021

The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level. About Polivy ® ( polatuzumab vedotin ) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC).

International 52

International Treatment Pharmacokinetics Therapies 52

The Pharma Data

OCTOBER 14, 2020

The new services have been developed to support pre-clinical research by optimizing hiPSC-derived cell culture, while providing high-quality electrophysiological data acquisition and analysis from physiologically relevant human cell models. Axol Bioscience – Based in the U.K.,

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. The Phase 2b trial is expected to begin during the second half of 2021.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

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FDA Clinical Trials Disease Trials 59

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

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Clinical Trials Treatment Trials Disease 52

Agency IQ

FEBRUARY 2, 2024

The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. Analysis, and what’s next In general, this guideline is attempting to cover a large amount of regulatory territory in a single document.

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Drug Target Review

JANUARY 20, 2025

This approach underlies the identification of the OBD, backed by both clinical efficacy and drug tolerability data. Pharmacologically-guided dosing : Integrating pharmacokinetics (PK), pharmacodynamics (PD), and translational biomarkers into dose selection tailors drug administration regimens that maximize the therapeutic index of a drug.

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Clinical Trials Trials Drugs Drug Development 52

The Pharma Data

DECEMBER 23, 2020

The study’s primary endpoints include safety, tolerability and pharmacokinetics of anle138b in Parkinson’s patients in order to establish the optimal dosing scheme for future long-term efficacy trials. Funding efforts were led by Robin Tombs, co-Founder of Yoti and previously of Gamesys, and other angel investors.

Licensing 52

Licensing Licensing Vaccine Trials 52

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.

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Clinical Trials Trials Clinical Pharmacology Drug Development 52