TECHNICAL STEPS AND CHALLENGING DECISIONS DURING REGISTRATION OF DRUG PRODUCTS
Journal Title: World Journal of Pharmaceutical and life sciences - Year 2018, Vol 4, Issue 10
Abstract
Regulatory Affairs in the Parma Industry may be defined as "The interface between the pharmaceutical company and the regulatory agencies across the world." Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products[1-6] in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory agency in the present context may be defined as "The competent government agency which is responsible for ensuring that medicines work and are acceptably safe."
Authors and Affiliations
D. Nagarjuna Reddy
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Objectives: To determine the occurrence of carbapenam resistance among MDR-GNB isolates by phenotypic methods. Introduction: Cabapenams posses the broadest spectrum of activity against gram positive and gram negative bac...
IDENTIFICATION ACTIVE COMPOUNDS OF BACTERIA STREPTOMYCES USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY
Aim of the study assess optimum Growth of Streptomyces and identification active compounds of bacteria Streptomyces using HPLC. The biochemical and physiological testes of Streptomyces sp. Show that the Streptomyces prod...
AN AYURVEDIC APPROACH TO UNDERSTAND SAMPRAPTI OF POLYCYSTIC OVARY SYNDROME
PCOS, one of the anuktavyadhi as per Ayurvedic medical science, needs a special contemplation because of its increasing prevalence among young girls in their reproductive age in India. Basically, this article is review o...
BIOPSY- AN OVERVIEW
Proper management of an oral mucosal lesion begins with diagnosis, and the gold standard for diagnosing disease, oral or otherwise, is tissue biopsy. Oral tissue biopsy may be necessary for lesions that cannot be diagnos...
FORMULATION AND EVALUATION OF EUDRAGIT RL 100 AND EUDRAGIT RS100 LOADED SESQUITERPENOIDS NANOPARTICLES
Objective: β-Caryophyllene (BCP) is a natural sesquiterpene existing in the essential oil of many plants, has exhibited a wide range of biological activities. However, its volatility and poor water-solubility limit its a...