Remove Bioavailability Remove Drugs Remove In-Vivo Remove Trials
article thumbnail

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Approaches to Pharmacokinetic Analysis.

article thumbnail

The Composition and Value of a Portfolio Analysis

Camargo

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Incentive Programs. Clinical Pharmacology.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo.

Trials 69
article thumbnail

Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

article thumbnail

Advancing from Research to Development: What Can Go Wrong?

Camargo

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. This blog post offers advice for avoiding major pitfalls during the drug development process. Overview of a Drug Development Program.

article thumbnail

Fibrosis research: Advances and challenges 

Drug Discovery World

Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. Only a few drugs have received approval for fibrotic diseases like IPF (idiopathic pulmonary fibrosis).

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).