efficacy

Unwanted materials that coexist with active pharmaceutical ingredients (APIs), surface during formulation, or become apparent after the formulation and API have run out are known as pharmaceutical impurities. The therapeutic properties of generic drugs may be affected, even in minute quantities, by the creation of these chemical pollutants. The pharmaceutical business is currently facing significant issues with impurity control. Researchers from the International Conference on Harmonization (ICH) have worked to manage pollutants. This review describes various impurity types, sources, and degrading transcription factors using specific examples.

The term biosimilar is used for a subsequently launched version of a biologic product which is similar in terms of quality, safety, and efficacy to an already licensed “Reference Biologic” product. The primary purpose of biosimilars is to reduce the healthcare costs associated with the use of biologics and thereby increase access to healthcare. Unlike small molecule generics, the bioequivalence approach is not considered appropriate for the approval of biosimilars. The approval of biosimilars is based on a stepwise comparability exercise with the “Reference Biologic”, starting with a comprehensive physicochemical and biological characterization. The extent and nature of the required nonclinical in vivo studies and clinical studies depend on the level of evidence obtained from the previous steps. Regulations require that the “Reference Biologic” should have been licensed/approved in the same country/region or in other ICH countries based on a full registration dossier. Apart from the comparability exercise, regulations also deal with indication extrapolation, pharmacovigilance, and substitution and interchangeability. This chapter also briefly describes the considerations for exclusivity, market access, and commercialization of biosimilars.

Biomarkers provide a dynamic and powerful approach to understand the spectrum of various diseases with applications in observational and analytic epidemiology, randomised clinical trials, screening and diagnosis and prognosis. In the recent years knowledge about biomarkers has increased tremendously providing great opportunities for improving the management of patients by enhancing the efficacy of detection and efficacy of treatment. This review provides a brief account on various biomarkers for diagnosis, prognosis and therapeutic purposes, which include markers already in clinical practice as well as various upcoming biomarkers.