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The Composition and Value of a Portfolio Analysis

Camargo

Pediatric Research Equity Act (PREA) Requirements. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence. Biowaiver Eligibility. Nonclinical Requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies.

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

Pharmaceutical Technology

Understanding the polymorphism of a drug compound plays a key role in both drug substance and drug product development, because it can negatively impact the downstream stability, solubility, and bioavailability of a drug.

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

The Pharma Data

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. About Molnupiravir.

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