Bioequivalency, In-Vitro and Packaging - Clinical Research Informer

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Bioequivalency

In-Vitro

Packaging

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. In vitro release testing to demonstrate bioequivalence.

Production

Production Manufacturing Development Bioequivalency

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

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Development

Development Drugs Bioavailability In-Vivo

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

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

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