Current Issue : January-March Volume : 2024 Issue Number : 1 Articles : 3 Articles
The development of new drugs requires extensive research in the areas of manufacturing controls, chemistry, preclinical trials and clinical trials. To obtain Marketing Authorization Application (MAA) approval for a new drug, different countries must adhere to various regulatory standards. Before a drug can be granted market approval, it must pass through clinical trials to ensure its safety, efficacy and quality control of new drug products to serve public health. Each country has its own regulatory authorities that are responsible for enforcing rules and regulations and issuing guidelines to regulate the marketing of drugs. Given the existing conditions, this study endeavors to express the drug approval process and regulatory requirements according to the United States Food and Drug Administration (USFDA) in the USA, Central Drugs Standard Control Organization (CDSCO) in India and European Medicines Agency (EMA) in Europe....
This case report illustrates a comprehensive approach to managing a late-term pregnancy complicated by Gestational Diabetes Mellitus (GDM) in a patient (YOGESHWARI - 26Y) at 38+5 weeks of gestation. The patient's journey, including diagnosis, monitoring and delivery, highlights the significance of integrating obstetric care with a multidisciplinary management strategy. Presented at St. Isabel’s Hospital in Mylapore with irregular lower abdominal pain and white vaginal discharge. Yogeshwari had a history of regular menstrual cycles and a previous normal vaginal delivery (NVD). GDM was diagnosed at 20 weeks and managed exclusively through diet. Regular ultrasound examinations throughout the pregnancy indicated normal fetal development, demonstrating the effectiveness of continuous fetal monitoring in GDM pregnancies. The management of Yogeshwari included not only strict dietary control and routine obstetric care but also involved a coordinated approach with specialists in endocrinology, nutrition and obstetrics. This collaborative strategy ensured both maternal and fetal health were optimally monitored and managed. As full term approached, labor was induced with oxytocin, considering the patient's gestational age and her GDM status. This induction resulted in the successful delivery of a healthy baby, showcasing the effectiveness of a multidisciplinary approach in managing complex pregnancies like GDM....
This review article explores the dynamic landscape of personalized medicine and its profound implications for pharmacy practice and patient care. Beginning with an overview of personalized medicine's evolution, the narrative delves into key areas, including pharmacogenomics, individualized drug therapy and the integration of technology. Challenges related to ethics, access and education are addressed, highlighting the need for comprehensive solutions. The impact on patient outcomes, spanning enhanced efficacy, safety and satisfaction, underscores the tangible benefits of tailoring medications to individual characteristics. The evolving role of PharmD professionals is examined, emphasizing training, collaboration and future opportunities. Looking forward, the article explores emerging technologies, potential breakthroughs and their implications for the future of pharmacy practice. In conclusion, the call to embrace the evolution of personalized medicine is echoed, with a focus on continuous learning, innovation and patient-centered care....
Loading....