CDSCO Introduction The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and […]
Diploma in Pharmacy Exit Examination Regulations Objective The objective of the Diploma in Pharmacy Exit Examination (DPEE) is to ensure that a candidate applying for registration as pharmacist with the State Pharmacy Council has undergone pharmacy education and a comprehensive […]
Pharmacovigilance in India Indian pharmaceutical industries are estimated to account for about 3.5% in value of the international pharmaceutical industry. By 2020, it is expected to grow to US$55 billion and US$100 billion by 2025, thus evolving as the sixth […]
CIOMS: The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, which include […]
ICH ICSR E2B R3 Guideline The ICH E2B EWG released an E2B guideline for Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSR) in 1997 and issued a revised […]
STANDARDS FOR EXPEDITED REPORTING A. What Should be Reported? 1. Single Cases of Serious, Unexpected ADRs All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and […]
Introduction: • ICH is the “International Conference on Harmonization” of technical requirements for the registration of pharmaceuticals for human use. • To assure safety, quality and efficacy of medicines, the members of ICH who include members from drug regulatory authorities […]
Preclinical studies are performed in in vitro, in vivo, ex vivo, and in silico models to obtain basic information about the safety and biological efficacy of a drug candidate before testing it in a final target population, i.e., humans. Preclinical […]
Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, clinical studies . During Phase 0, pharmacodynamics and pharmacokinetics are determined. Safety […]