Wound healing has always been an important issue that needs to be addressed, especially where second-and third-degree burns are considered. These types of burns extend to the dermis in second-degree burns and the tissues in third-degree burns and this process is extremely slow. Hypertrophic scarring and infection which are caused due to decreased immunity are some of the obstacles that need to be tackled. Recent studies show that fish collagen is useful in preventing infections due to its natural antimicrobial properties. Increased cellular respiration, exudate removal and retention of moisture are a few events that promote wound healing and these are aided by electrospun nanofibrous mats. Combining the properties of collagen into the nanofibrous mats in order to facilitate wound healing can potentially serve as an alternative to the current wound healing therapies. This article covers the various types of collagen that can be used with a focus on the synthetic polymeric blending into the collagen structures and its electrospinning process.
The rate and extent of absorption of a drug from its dosage form is referred to as bioavailability. While bioequivalence between two drug products is attained if their extent and rate of absorption do not relatively differ when administered at the same dose. A bioequivalence study comprises of two or more bioavailability studies which are performed by i) Measurement of active drug substance or its metabolites in the biological fluid; ii) Comparative pharmacodynamic studies in humans; iii) Comparative clinical trials; iv) Comparative in-vitro dissolution studies. The rationale of the study is the monitoring of the pharmacokinetic-pharmacodynamic parameters (AUC, C max ) after administration of the tested drug. This study is not an experimental study but a form of data analysis and reporting of comparative bioavailability studies. The study data obtained is required to be equipped with applications of new drug products as notified in Schedule Y. Cumulatively, it aids in the development of pharmaceutical preparations in the pharmaceutical industry. This review article aims to illustrate the systematic overview of BA/BE study with an emphasis on its experimental aspects like study design, volunteer selection, dosing regimen, sample collection procedures along with a detailed insight on Informed Consent Document, Case Report Form, Trial Master file and the Protocol which collectively form the backbone of the clinical study.
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