article thumbnail

Genotoxicity Testing: Unlocking the Future Safety Assessment Opportunities

Roots Analysis

Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. Mechanism of Genotoxicity / Mutagenicity The interaction of genotoxins / mutagens with the structure of DNA causes damage to the genetic material.

article thumbnail

Development of Oncology Therapies – Tips from the FDA to Drive Success

Camargo

This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.

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 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. Nonclinical Requirements.

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.

In-Vitro 100
article thumbnail

IN FOCUS: Solvias

Pharmaceutical Technology

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Integrated analytical services for pharmaceuticals.

article thumbnail

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development. Polymorphic form issues.

article thumbnail

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. hypoxia, cough, dyspnea).

HR 52