Remove Development Remove Genotoxicity Remove In-Vivo Remove Trials
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. Clinical Pharmacology. Clinical Safety and Efficacy.

article thumbnail

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

The Pharma Data

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. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We

Trials 69
Insiders

Sign Up for our Newsletter

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

article thumbnail

The Future for Biotesting

Pharmaceutical Technology

The first activities of the company concerned the pre-clinical toxicological testing of several new candidate molecules showing cytostatic activity, initially developed by a former research institute, as well as the breeding and supplying of laboratory animals. . Dr Ivana Surovà: Biotest s.r.o. Can you reveal the results of these?

In-Vitro 130
article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Drug discovery and development is an arduous process that can cost upwards of $2.6 This stage is more highly regulated and consists of both preclinical testing and clinical trials. Until recently, drug carcinogenicity assessment required two different in vivo studies, one of which was typically a two-year lifetime study in rats.