Bioequivalency In-Vivo Manufacturing 
Camargo
DECEMBER 22, 2021
For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Fine-Tuning Strategic Assessment. Clinical Pharmacology.
Drug Patent Watch
JANUARY 14, 2025
Case Study 1: Overcoming Formulation Challenges Let’s kick things off with a look at how generic drug manufacturers are tackling formulation challenges head-on. Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1].
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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.
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.
Pharmaceutical Technology
FEBRUARY 23, 2023
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
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