Impact assessment of integrated-pathy on cancer-related fatigue in cancer patients: an observational study.

BACKGROUND: Integrated-pathy aims to integrate modern medicine with traditional systems via applying the holistic approach of Ayurveda, Yoga, and natural medicine. This is important for addressing the challenges surrounding the delivery of long-term palliative care for chronic ailments including cancer. The prime intent of this study was to substantiate the underlying hypothesis behind the differential and integrative approach having a positive impact on Quality of Life of cancer patients. STUDY DESIGN: Cross-sectional Observational study. METHODS: A standardized questionnaire was developed and used, after obtaining written informed consent from patients to assess the impact of Integrated-pathy on patients (n = 103) diagnosed with cancer receiving care at Patanjali Yoggram. The research was carried out over 8 months. All participants received a uniform treatment protocol as prescribed by Patanjali. For the sample size determination and validation, α and 1-ß was calculated and for the significance of the pre- and post-treatment QoL ratings, Shapiro wilk test and other descriptive statistics techniques were explored. RESULTS: A total of 103 patients seeking cancer special-healthcare were interviewed, out of which 39 (37.86%) remained finally based on the inclusion/exclusion criteria with age (25-65 years), types of cancers (Carcinoma and Sarcoma), chemotherapy/radiotherapy received or not, before opting Integrated-pathy. Follow-ups revealed a significant increase in the QoL (17.91%) after receiving the integrated therapy over a course of at least 1 month. Further, a significant reduction in cancer-related pain followed by an increase in QoL index was reported in the patients. Shapiro-wilk test revealed significant pairing (p < 0.001) with validation of the model using test. CONCLUSIONS: To bolster evidence-based backing for Integrated-pathy, there is a need for clearly delineated clinical indicators that are measurable and trackable over time. Clinical investigators are encouraged to incorporate Integrated-pathy into their proposed interventions and conduct analogous studies to yield sustained advantages in the long run.

Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review.

The development of monoclonal antibody (mAb) biosimilars is a complex process. The key to their successful development and commercialization is an in-depth understanding of the key product attributes that impact safety and efficacy and the strategies to control them. Functional assessment of mAb is a crucial part of the comparability of biopharmaceutical drugs. The development of a relevant and robust functional assay requires an interdisciplinary approach and sufficient flexibility to balance regulatory concerns as well as dynamics and variability during the manufacturing process. Although many advanced tools are available to study and compare the potency and bioactivity of the protein, most of these techniques suffer from major shortcomings that limit their routine use. These include the complexity of the task, establishment of the relevance of the chosen method with the mechanism of action (MOA) of the biosimilar, cost and extended time of analysis, and often the ambiguity in interpretation of the resulting data. To overcome or to address these challenges, the use of multiple orthogonal state-of-the-art techniques is a necessary prerequisite.

Understanding Oxidation Propensity in GCSF and Assessment of its Safety and Efficacy.

PURPOSE: To understand the impact of methionine oxidation in GCSF on efficacy (neutrophil production/activation) and safety (biochemical and histopathological changes). METHODS: Nine GCSF biosimilars were analyzed for the levels of residual iron and copper content. Oxidation in GCSF was induced by H2O2 treatment and four samples were prepared: wtGCSF (no oxidation), MetO (1138), MetO (1,138,127) and MetO (1138,127,122). These samples were used to evaluate binding affinity with the GCSF receptor (GCSFR) using biolayer interferometry, thermal stability using circular dichroism and in vitro potency using a relevant cell-based assay. In vivo pharmacodynamics examined changes in neutrophil production upon GCSF methionine oxidation, with the outcome correlated with the differential expression of genes implicated in the GCSF mediated neutrophil activation/ maturation. Pre-clinical safety studies including biochemical and histopathological changes were also performed. RESULTS: Met 122 and Met 127 have the most deleterious effect on the potency. Lower binding affinity with GCSFR was identified as the underlying cause for lower efficacy and potency. Role of Asp 110 in GCSF as the critical residue having adverse impact on efficacy in context of methionine oxidation has been elucidated. Impairment of in vitro binding affinity with GCSF manifests as in vivo pharmacodynamic differences via differential expression of downstream genes required for neutrophil maturation. CONCLUSION: The data from the present study suggests that methionine oxidation in GCSF is a critical quality attribute that needs careful monitoring and control during commercial manufacturing and subsequent supply chain stages.