Camargo

FEBRUARY 10, 2021

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. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Approaches to Pharmacokinetic Analysis.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

Drug Patent Watch

DECEMBER 11, 2024

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). They provide recommendations on the design of in vitro and in vivo studies. They offer guidance on formulation development and manufacturing considerations.

Generic Drugs 95

Generic Drugs Production Development Bioequivalency 95

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. Simplicity matters. Optimising development and scale-up.

Production 130

Production Manufacturing Development Bioequivalency 130

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 246

Development Drugs Bioavailability In-Vivo 246