Clinical research

Is India Losing Its Edge In Clinical Trials? – Pharmalot Blog

Submitted by joshipuramanan on Wed, 02/20/2013 - 05:54

Amid court rulings and ongoing protests in India over protecting patients in clinical trials, the pace at which trials are being approved has reportedly slowed. Consequently, questions are being raised about the ongoing ability of the country to remain a fast-growing hub for medical research and uncertainty about what some call a sluggish bureaucracy is prompting some drugmakers to shift operations elsewhere

 

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Topic: 
Clinical research

Clinical Trials in India: At the cost of human lives?

Submitted by Shloka Shankar on Mon, 09/10/2012 - 13:36

I recently came across this article that had me quite bewildered, to be honest. What is happening to a country like India? It's hardly surprising when we follow in the footsteps of countries like America. With their ignominious FDA unapproved trials, clinical trials in India are being taken for granted at the cost of human lives.

ICH Guidelines!!

Submitted by sirisha on Wed, 11/30/2011 - 16:03
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use which we simply refer as ICH is a distinct in getting together the various "regulatory authorities and pharmaceutical industry" of Japan, Europe and US to discuss about various scientific and technical requirements of drug registration.

SHONIN!!!!! KYOKA!!!!!

Submitted by sirisha on Wed, 11/16/2011 - 10:08
Hello everyone, the topic I chose for this month is purely based on the two catchy words mentioned in the title, SHONIN and KYOKA. I was going through this book and suddenly I noticed a subheading DRUG REGISTRATION IN JAPAN. The Japanese constitutes the greatest consumers of pharmaceutical products "per capita" in the world.

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:

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.