Remove Clinical Development Remove Definition Remove Pharmacokinetics
article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

4 The definition has since evolved and expanded to include molecular signatures of pharmacodynamics and therapeutic response. As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms.

article thumbnail

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

Agency IQ

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. What does that mean: “Phase 3”?

Science 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

article thumbnail

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

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.

Science 40
article thumbnail

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

The Heckler case helped to refine the definition of “substantial evidence” in two important ways. In 1997, Congress passed the FDA Modernization Act (FDAMA) , which—among other reforms— updated the definition of “substantial evidence” to allow for additional types of evidence, or “confirmatory evidence.” When should this occur?

FDA 40
article thumbnail

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. It also contains a definition of the term immunotoxicity— the unintended immunosuppression or stimulation (including hypersensitivity) —which was notably absent from the draft.

FDA 40
article thumbnail

Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

The primary objective is invasive disease-free survival (IDFS) defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death.

Trials 52