Significant efforts are made to characterize molecular liabilities and degradation of the drug
substance (DS) and drug product (DP) during various product life-cycle stages. The in vivo …

The skin has been employed as a delivery route for localized as well as systemic delivery of
drugs. However, the Stratum corneum (SC) of the skin act as a main barrier for the …

Background IL-17A is a key driver of human autoimmune diseases, particularly psoriasis.
Objective We sought to determine the role of IL-17A in psoriasis pathogenesis and to identify …

Background The availability of generic topical dermatological drug products is constrained
by the limited methods established to assess topical bioequivalence (BE). A novel …

For many years subcutaneous (SC) administration has represented the main route for
delivering biopharmaceuticals. However, little information exists about the milieu in the …

Psoriasis, psoriatic arthritis, and axial spondyloarthritis are systemic inflammatory diseases,
each commonly manifesting as a spectrum of symptoms, complications, and comorbidities …

Secukinumab is a human monoclonal antibody with demonstrated efficacy for moderate to
severe psoriasis; it binds to and neutralizes interleukin (IL)‐17A. The pharmacokinetic (PK) …

The series of conferences of the Global Bioequivalence Harmonisation Initiative (GBHI) was
started in 2015 by the European Federation for Pharmaceutical Sciences (EUFEPS). All …

Here we have reported whole-body disposition of wild-type IgG and FcRn non-binding IgG
in mice, determined using Enzyme-Linked Immunosorbent Assay (ELISA). The disposition …

Therapeutic monoclonal antibodies (mAbs) exhibit limited distribution to the target tissues.
Determination of target tissue interstitial concentration of mAbs is an important aspect in the …