Drug development

METHOD VALIDATION PROCESS AND PARAMETERS

Hi friends in this blog I would like to putforth few aspects regarding the analytical method validation parameters and its procedure.

"Analytical method validation is the process of demonstrating that the analytical method is acceptable for its intended purpose."[1] Generally the user or developer of the method generates evidence on accuracy, precision, specificity, linearity range, detection limit, quantitation limit, ruggedness and robustness of the method for regulatory submission.[2]

GLUTAMATERGIC NEUROTRANSMISSION

Hi everybody, first of all I would like to sincerely apologize for the delay in putting up my blog for this month as I was a bit busy with my academic schedule. Here this time I would like to discuss briefly about Glutamatergic neurotransmission which is one of the key neurotransmission pathways involved in functioning of brain. It plays an important role in learning and memory.

General Rules in Pharmacology Practicals

Most of the pharmacology practicals are regarding the study of drug action on biological systems. These are mostly done using organ preparations isolated from some of the commonly used laboratory animals such as Frog's, Guinea pigs, Albino Rats, Mice etc.

Following are some rules or general procedure that a student should follow in order to carry out the experiment successfully.

Biomarkers

BIOMARKERS Our body is built up with various protecting and preserving elements yet in bringing out surprising discoveries.... One such is the biomarkers!! Biomarkers are the chemical substances released in the body which indicates the present condition/ state and also the extent of risk to a particular tissue or organ.

China CPU Challengers May Topics

The Month of April has been one of the tough month for most of us, due to a personal School Schedule. Therefore, we couldn't cover all the topic announced. However, this Month of May, we will discuss on: -Naltrexone -Tramadol -Asthma -Crohn's Disease -Gene Therapy and cancer -Modern Pharmacy Vs Traditional Pharmacy -Mechanized nanoparticles for Drug Delivery Part Two

Dose Dumping - USFDA Regulatory perspective

There were many reasons for dose dumping of an extended release dosage form like improper design of dosage form, drug excipient interactions, crushing or chewing by patient1, intake of food or alcohol2 of which dose dumping due to alcohol is of more concern. Dose dumping due to alcohol was initially identified in palladone capsules that contain hydromorphone used to treat pain2. It is a potent narcotic with the dose of 12mg.

Preclinical Studies in Drug Development

Hi Friends, my first blog for this month is regarding Preclinical studies in Drug development. After its discovery in the laboratory every New Chemical Entity NCE)should face a series of challenges/trials to make its way into the market successfully. The entire drug development process can be divided into the following steps: [1] 1. Preclinical Studies/Trials