Pharmaceutical Business Review

AUGUST 28, 2023

Allucent is engaged in providing comprehensive drug development solutions including consulting, biometrics, clinical operations, and clinical pharmacology across various therapeutic areas. The post Allucent to expedite Covid-19 booster vaccines development appeared first on Pharmaceutical Business review.

Vaccines 52

Vaccines Clinical Pharmacology Immunization Immunity 52

Express Pharma

MARCH 21, 2023

In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development 52

FDA Law Blog: Biosimilars

JULY 17, 2024

clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., In fact, at this Scientific Workshop, Frank called for the creation of an alternative effectiveness standard for ultra rare diseases that relies on all available scientifically valid evidence (e.g.,

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

European Pharmaceutical Review

MARCH 11, 2024

As a physician scientist with knowledge and experience in translational medicine and late-stage drug development, Sherene has a proven record in drug development including successful regulatory interactions with US and international agencies.

Immunization 98

Immunization Immunity Clinical Pharmacology Drug Development 98

pharmaphorum

NOVEMBER 4, 2020

The M&S approach should be integrative, from the molecular level to the clinical and population outcomes. It should be conceived both as a proof of concept tool and a MIDD (Model Informed Drug Development, to use the FDA jargon) tool for potential treatments, including vaccines, and combinations of drugs.

Vaccines 105

Vaccines Clinical Pharmacology Immunization Immunity 105

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

European Pharmaceutical Review

JULY 13, 2023

1 Europe, however, is well placed to become a leader in driving the clinical translation of medications that display significant promise in laboratory-based studies. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. Expert Review of Clinical Pharmacology.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

Putting Patients First Blog

SEPTEMBER 26, 2024

Further discussion on the unique aspects of rare disease drug development, the associated challenges, and when waivers may be warranted would greatly benefit all stakeholders, including sponsors, patient organizations, clinical researchers, and regulators. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

The Guidance notes that extrapolation of data across species is challenging; however, in accord with Agency pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible.

Clinical Pharmacology 64

Clinical Pharmacology Communication Drug Development 64