Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

Basic considerations in the dermatokinetics of topical formulations

Assessing the bioavailability of drug molecules at the site of action provides better insight into the efficiency of a dosage form. However, determining drug concentration in the skin layers following topical application of dermatological formulations is a great challenge. The protocols followed in oral formulations could not be applied for topical dosage forms. The regulatory agencies are cons...

Bioequivalence of Topical Dermatological Drug Products

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

In recent years, the clinical research business developed extremely fast in emerging countries such as China, India and Philippines, mainly because of increased high investigation fees in western countries. Specifically in China, an additional portion of drug applications falls under the area that requires bioequivalence study or clinical trials due to the amendment of the Drug Registration Reg...

Challenges obtaining a biowaiver for topical veterinary dosage forms.

Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However, the skin of domestic animals varies anatomically and biochemically and experimental approaches to assess bioequivalence (BE) in veterinary species have challenges that are not often encountered with human skin. This is especially the situation with locall...

A critical comparison between dosage forms in traditional Persian pharmacy and those reported in current pharmaceutical sciences

There were many natural pharmaceutical dosage forms cited by Persian pharmacists and physicians in the historical pharmacopeias (Qarabadins). This work aimed to perform a comprehensive study on “Qarābādin-e-Sālehi” (1765 A.D.), one of the main Persian pharmaceutical manuscripts defining traditional dosage forms. All traditional dosage forms as well as their definitions, descri...