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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.

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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.

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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. Fine-Tuning Strategic Assessment.

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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.

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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. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity.

HR 52
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FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

Chief Development Officer, Oncology, Pfizer Global Product Development. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

HR 52
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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

This involves careful selection and development of packaging systems with considerations of stability, storage, accelerated aging, freeze-thaw, altitude, drop, vibration distribution simulation, as well as identification and characterization of compounds released from packaging materials (i.e. shaking, changes in pressure, etc.).