Clinical Research, International and Pharmacokinetics

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International

Pharmacokinetics

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

Trials

Trials Clinical Trials Regulations FDA

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

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. WHY IS PAIN RESEARCH SO IMPORTANT? WHAT IS PAIN AWARENESS MONTH? in 2001.

Clinical Trials

Clinical Trials Treatment Trials Drug Development

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Drug Discovery World

What Does a CRO Actually Do?

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.

Clinical Trials

Clinical Trials Compliance Trials Laboratories

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

Dr Sodergren told DDW in an exclusive comment: “I am hopeful that over the next few years we will see further investments by governments and funding bodies to accelerate pre-clinical and clinical research programmes. Examples of people on the Power List include Susan Audino in the Analytical Heroes category. deletion syndrome.

Clinical Trials

Clinical Trials Regulations Production FDA

4 Unique Challenges of Oncology Trials

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. This means study startup times can vary greatly.

Trials

Trials Clinical Trials FDA Approval Animal Testing

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

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. Lykos personnel responded by stating that internal investigations led to policy changes and additional training regarding boundary setting for patients and providers.

FDA

FDA Trials Regulations Therapies

Novo Nordisk: positivity for haemophilia treatment

Drug Discovery World

AUGUST 8, 2022

The company has been investigating Mim8 in its Phase I & II FRONTIER1 study and recently reported positive interim results from the study at the International Society of Thrombosis and Haemostasis Annual Congress (ISTH 2022) in London, UK. . Abstract presented at International Society of Thrombosis and Haemostasis (ISTH) 2022.

Treatment

Treatment Clinical Trials International Disease

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

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

Trials Disease Treatment Pharmacokinetics

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

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.

Clinical Trials

Clinical Trials Treatment Trials Disease

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

For many drug developers, this guidance has been long-awaited, as it emphasizes inclusivity of underrepresented and minority populations not only in late-stage clinical trials but throughout the entire clinical process, including early stages.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics

Phase III study shows Roche’s Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care

The Pharma Data

AUGUST 9, 2021

POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level.

International

International Treatment Pharmacokinetics Disease

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

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.

FDA

FDA Research Clinical Trials Regulations

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

The TMVR technology developed by HighLife uses a transeptal approach to treat patients with MR, and is currently evaluated in international clinical studies in more than 20 sites on three continents. . Funding efforts were led by Robin Tombs, co-Founder of Yoti and previously of Gamesys, and other angel investors.

Licensing

Licensing Licensing Vaccine Compliance

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

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

Science FDA Production Trials

Drug Discovery Digest

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Trending Sources

What Does a CRO Actually Do?

Where is the promise for plant-based medicines? Part 1: Cannabis

4 Unique Challenges of Oncology Trials

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Novo Nordisk: positivity for haemophilia treatment

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

How Improving Diversity Can Benefit Clinical Trials

Phase III study shows Roche’s Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

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