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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.

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The Composition and Value of a Portfolio Analysis

Camargo

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

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Advancing from Research to Development: What Can Go Wrong?

Camargo

Nonclinical programs include (but are not limited to) method development and validation, pharmacokinetic studies, in vivo efficacy studies, safety pharmacology, IND-enabling toxicology studies, and long-term studies when appropriate. Overview of Drug Development Programs (Through IND Submission). CMC Considerations. Non-scalable process.

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

Pharmaceutical Technology

Best practice is to also consider the ‘developability’ of the lead compounds in conjunction with any evidence of potential in-vivo activity, by taking a holistic approach. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

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

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.