Life is a Journey..how to make the best of it!

BayBiotech.NET This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment. We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows: Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology. Pharmacokinetics: is the study of the time course of d

BayBiotech.NET We often think of clinical trials as a principle method of studying new drugs, but there are many different types of trials that are designed to answer different questions related to health care and well beings of the human subject. Understanding the objective of your clinical trial and the entire process is the first step taken towards determining the regulatory pathways that will apply to a particular study. Depending on the end-goal different types of clinical trials are as under: • Prevention trials – Prevention trials look at substances and lifestyle factors that may raise or lower the risk of developing a clinical condition. e.g. effect of a particular type of food or exercise on preventing Diabetes. • Screening trials – Screening trials are designed to diagnose a condition in its early stages when it is often more curable. e.g. a newly developed imaging technique if used to screen breast cancer occurrence. • Diagnostic trials – Diagnostic trials are aimed