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

Pharmaceutical Technology

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. Polymorphic form issues.

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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. Incentive Programs. Biowaiver Eligibility.

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

Camargo

Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies. Become Fluent in the Drug Development “Languages.”.

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The Future for Biotesting

Pharmaceutical Technology

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

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IN FOCUS: Solvias

Pharmaceutical Technology

Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Solvias is well equipped to provide stability testing for all stages of drug development. Integrated analytical services for pharmaceuticals. Quality control release testing.

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ICH announces sign-off of residual solvent guideline

The Pharma Data

According to a Step 4 training presentation on the guideline, the Q3C (R8) Expert Working Group (EWG) review of available toxicity data with 2-MTHF, also known as tert -butylmethyl ether, found no evidence for genotoxicity or reproductive toxicity and no observed effect level in repeat dose toxicity studies involving rats.

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

The Pharma Data

The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).

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