Food and Drug Administration

NEW DRUG APPLICATION!!!

Submitted by dr girija sankar on Sun, 10/16/2011 - 14:34
Hello my dear student friends, I hope everyone is busy and doing well in the exams!! With the new igniting minds i hope every one of you want to do something new. Coming to our profession, Novelty, Utility and Non Obviousness-(the major essentials of a patent) are necessary whenever you discover a new product. Before you begin the clinical trials first thing you need to do is, apply for Investigational New Drug Application or IND. A brief discussion of IND will be given by Gangadhar Hari!!

Sterility testing-Parenteral Dosage Forms

Submitted by vijay m.pharm bcop on Fri, 05/13/2011 - 07:05

Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample number of containers taken from batch of product. Based on results obtained from testing the sample a decision is made as to the sterility of the batch1.

There are two common types of sterility test methods:

Validation Part -II

Submitted by shikha_Chauhan on Fri, 03/18/2011 - 05:50
Dear Bloggers, I am back again, to you all with my second blog for this month. After going through basics of validation in my first blog (validation Part-I), now I am going to share about: - Types of Validation - Phases of Validation - Equipment Validation - Strategy for Validation -Approaches to Validation Types of Validation Prospective Validation:

Dose Dumping - USFDA Regulatory perspective

Submitted by tegkmurthy on Tue, 03/15/2011 - 13:00

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.

Scale up and post approval changes(SUPAC)

Submitted by sailesh on Tue, 03/15/2011 - 12:46

This is a guidance document that comes under Chemistry manufacturing and controls section of USFDA. During formulation development, initially, development process is carried out in small batch sizes generally in the multiples of 10X i.e., small scale or lab scale. The batch size is then increased to multiples of 100X i.e., medium scale or pilot scale. In production scale or large scale, manufacturing is carried out in large numbers usually multiples of 1000X depending upon the requirement.

Preclinical Studies in Drug Development

Submitted by gangadhar hari on Sun, 03/13/2011 - 10:15
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

Orally disintegrating tablets using multiparticulates

Submitted by sailesh on Tue, 02/15/2011 - 13:39

Orally disintegrating tablets also called as fast dissolving or mouth dissolving tablets are such kind of dosage forms which when placed in mouth disintegrates rapidly in a matter of seconds(1). They are different from lozenges or buccal tablets which require more than a minute to get dissolved in mouth(1). Any dosage form or a novel drug delivery system which improves patient compliance is of great interest to scientists in which orally disintegrating tablets stands first among them.