Postgraduate pharmacology curriculum in current scenario and future prospects: an educational forum

In India Doctorate of Medicine (MD) pharmacology is primarily knowledge oriented based on teaching, seminars, lectures and research related activities including animals and paper-based experiments and day to day management of undergraduate classes. MD pharmacology student should be competent of both clinical and experimental pharmacology. So, the postgraduate pharmacology curriculum should be competent to meet all the job requirements. Therefore, medical council of India (MCI) has introduced new post graduate curriculum which is based on knowledge, practical, clinical skills, thesis skills, and attitudes including communication and training in research. In India demand for skilled clinical research professionals is increasing day by day for growing pharma industries and good academician. So, there is an urgent need for the experienced and skilled pharmacologist to fulfil the requirements. MD pharmacology students should get posting in different clinical departments and observatory posting in industry, clinical research organization (CRO), regulatory body and research organisations. The course of MD Pharmacology should be like that fulfil all the skills that a pharmacologist must have.

Global Trials, Local Bodies: Negotiating Difference and Sameness in Indian For-profit Clinical Trials

Global clinical trials depend on a range of standards in order for research results to be comparable. As standardization is more than a mere technical exercise, tensions can arise when things are not uniform. This paper uses empirical data from interviews with principal investigators as well as Clinical Research Organization and pharmaceutical industry representatives working in India’s clinical trial industry to critically examine the ways Indian researchers navigate quests for standardization. It turns the analytical lens to the often obfuscated work of standardization aiming to transcend the biological and cultural specificity of research participants and research sites. Drawing on the concept of local biologies, it illustrates that the universal body presumed by clinical trial methodology is, in fact, a specifically Euro-American one: Indian participants not only need to be made globally comparable but also aligned with the drugs’ future consumers. Focusing on the tensions between biomedicine’s postulation of bodily universality and trial participants’ local biologies, this paper advances recent interventions problematizing the structural violence undergirding global clinical trials. It also contributes to the literature on local biologies in its discussion of how these are negotiated in Indian for-profit clinical trials.

Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption

Context The effect of sotagliflozin (a dual sodium–glucose cotransporter [SGLT] 2 and SGLT1 inhibitor) on intestinal glucose absorption has not been investigated in humans. Objective To measure rate of appearance of oral glucose (RaO) using a dual glucose tracer method following standardized mixed meals taken after single sotagliflozin or canagliflozin doses. Setting Clinical research organization Design and participants In a double-blind, 3-period crossover study (NCT01916863), 24 healthy participants were randomized to 2 cohorts of 12 participants. Within each cohort, participants were randomly assigned single oral doses of either sotagliflozin 400 mg, canagliflozin 300 mg, or placebo on each of test days 1, 8, and 15. On test days, Cohort 1 had breakfast containing [6,6-2H2] glucose 0.25 hours postdose and lunch containing [1-2H1] glucose 5.25 hours postdose; Cohort 2 had breakfast containing no labeled glucose 0.25 hours postdose and lunch containing [6,6-2H2] glucose 4.25 hours postdose. All participants received a 10- to 15-hour continuous [U-13C6] glucose infusion starting 5 hours before their first [6,6-2H2] glucose-containing meal. Main Outcome RaO, postprandial glucose (PPG), and postprandial insulin. Results Sotagliflozin and canagliflozin decreased area under the curve (AUC)0–1 hour and/or AUC0–2 hours for RaO, PPG, and insulin after breakfast and/or the 4.25-hour postdose lunch (P < .05 versus placebo). After the 5.25-hour postdose lunch, sotagliflozin lowered RaO AUC0–1 hour and PPG AUC0–5 hours versus both placebo and canagliflozin (P < .05). Conclusions Sotagliflozin delayed and blunted intestinal glucose absorption after meals, resulting in lower PPG and insulin levels, likely due to prolonged local inhibition of intestinal SGLT1 that persisted for ≥5 hours after dosing.

La implementación de un depósito para almacenaje de medicamentos de estudios clínicos

Empresa que pertenece a la industria Farmacéutica, ubicada dentro de la categoría de Estudios clínicos. Denominada CRO (Clinical Research Organization – Organización de investigación por contrato). El rol que cumple la CRO dentro de la cadena de valor de esta categoría, es realizar los estudios clínicos por encargo de las Empresas Farmacéuticas que realizan desarrollo e investigación de medicamentos. Una vez realizadas las investigaciones pre-clínicas y clínicas por las empresas farmacéuticas, estas contratan a Depósitos para almacenaje de la droga y a las CRO, quienes ejecutarán el proyecto en cada país encargándose de reclutar los grupos de personas en las que se realizarán las pruebas, distribuir las drogas en los grupos seleccionados, para proceder a analizar y entregar los resultados a la empresa farmacéutica. Si los resultados reportados por la CRO son óptimos, la empresa farmacéutica procederá a registrar la patente y a la comercialización de los medicamentos. El éxito de los resultados de los Estudios clínicos depende de 3 factores principales: 1. Un almacenaje correcto de la droga en estudio, bajo condiciones óptimas de conservación. 2. Compromiso de los pacientes participantes, siguiendo estrictamente las indicaciones y las dosis planificadas para cada uno de ellos. 3. Monitoreo y análisis por parte de la CRO Actualmente los servicios que provee BIOCLINICAL RESEARCH a las Industrias Farmacéuticas son: Asesoría en el diseño de protocolos. Reclutamiento de investigadores. Monitoreo de estudios clínicos. Análisis de datos. de Fármaco-Vigilancia. Gerenciamiento de desarrollo del estudio clínico para el cual ha sido contratada la Compañía. Manejo de resultados de Estudios clínicos Considerando el impacto que representa el correcto almacenaje de la droga en análisis, para los resultados obtenidos; BIOCLINICAL RESEARH creará una nueva Unidad de Negocio, referida al almacenaje de los medicamentos para Estudio Clínicos; pretendiendo de esta forma, cerrar el círculo de suministro de la droga en estudio, desde que se importa hasta que se distribuye a los Centros de investigación para uso del paciente.

HistoScanning, a new device to enhance ultrasound’s contribution to clinical assessment of pelvic masses

5056 Background: HistoScanning (HS) is a medical device developed to improve interpretation of echography. Ovarian (OV) HistoScanning (OVHS) performs computerized analysis of voxel files generated during transvaginal ultrasonography (TVS). OVHS was integrated into a protocol for investigation of ovarian pathologies, primarily cancer (OVCa). Methods: A study was initiated; a/ to standardize the echography procedure, b/ to evaluate OVHS ability to differentiate cancerous to non-cancerous pelvic masses under appropriate conditions. Women (W) ≥18 years old planned to have complete removal of ≥1 OV were eligible. Exclusion criteria include previous diagnosis of OV cancer, pelvic surgery, radiotherapy or chemotherapy for breast or OVCa. Real 3D-TVS were performed before surgery and the voxel data sent to AMD. After OVHS results were locked in the study’s data base, pathological reports were sent to the clinical research organization and the OVHS results were compared to histology. Results: From 09.2004 to 07.2005, 486 data files were obtained from 9 institutions. 120 were used for calibration, 97 had no surgery, and 269 met the protocol requirements. Pelvic histology includes normal OV (87), benign tumors (T) (78), past endometriosis (9), borderline cancers (21), adenocarcinomas (53), carcinomatosis (12), metastases (4) and other cancers (3), others (2). 91 cancers were correctly diagnosed (sensitivity 98%). Reason for false negatives was: lack of voxel data for the lesion (1) and pathology volume bellow US resolution (‘Cystadenofibroma with foci of low malignant potential; Borderline‘) (1). When gain used during TVS was appropriate, the false positive (FP) rate was 3% for normal tissues and 17% for benign tumors. When gain used was inappropriate, FP rate was 10% and 41%, respectively. Conclusion: OVHS seems highly sensitive for the diagnosis of pelvic masses while having an acceptable specificity. A study using 3D-TVS performed with controlled gain level is ongoing. [Table: see text]