fda

47. Tobacco - a nuisense created by man!

Submitted by Bhagavan P S on Tue, 01/10/2012 - 10:43
Thanks to Shiva for a good opening topic for 2012. I wish you are not a smoker or at least a ex-smoker now! Cigarette is one such product that does more harm when used in the right way! Cigarette is the only product on the market that is perhaps exempted from disclosing the contents. There are no quality parameters which you can use to cross check the quality.

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:

ANDA Paragraph- IV filing

Submitted by dipennvadalia on Wed, 03/31/2010 - 18:58

Dear all readers, last time unintentionally I have practiced plagiarism but I have corrected it by editing my blog. I hope this time you would not found this in my blog.
This time I am going to present about very important ANDA Paragraph- IV certification.

Before this it is necessary to know about the review procedure of ANDA application(see figure-1).
ANDA Process flow
figure-1: ANDA review procedure[1]

Biologics Target bad Bugs

Submitted by tkindira on Sun, 03/21/2010 - 11:26

Hello my dear Pharmainfo friends, I take this marked space to present my blog entry over this topic. What are bad bugs and why to target bag bugs? Infectious diseases account for almost 25% of mortality and morbidity and are emerging as the second most common cause of deaths worldwide as reported by World Health Organization survey [1].

Bioequivalence-A regulatory perspective- 1

Submitted by santosh kumar. JH on Sat, 03/20/2010 - 11:31
Let me start my discussion by narrating a personal experience. In my vacation time I went to Hyderabad to meet my senior and friend who is now working in the FR&D department of a big Pharmaceutical company in Hyderabad. I repeatedly tried to raise him on my phone and failed. I went to his room and waited for him for two days and he did not turn up. On the third day, looking very haggard he did turn up and I asked him anxiously "what happened to you?" He responded "My friend; you don't know what life in a pharmaceutical company is.

Biowaivers: Introduction

Submitted by Nik on Fri, 03/19/2010 - 17:35

Dear friends I would like to tell you a small story, before that about the term biowaivers.

'In simple words, a Biowaiver is a waiver (exemption) of clinical bioequivalence studies given to a drug product.'

Coming to the story, two friends (say Ajay and Vijay) are having a conversation, it so happens that the two of them are research scholars in pharmaceutical sciences.

Hatch-Waxman ACT: "Benefits to Patients???"

Submitted by dipennvadalia on Mon, 03/15/2010 - 09:07

Dear all readers, as our team leader Mr. Premchandani has introduced our team and about me for specially interested in topics related to IPR, here I want to post very interesting, important and very confusive topic of IPR in history of Pharmaceutical Regulation. This is...

Hatch-Waxman Act, 1984

History-

10. Hospital pharmacy series - 'Quality' of drugs

Submitted by Bhagavan P S on Thu, 12/24/2009 - 10:25

Quality of drugs:

Every one desire to have the best

This desire is nothing but an expression based on ‘Quality’ consciousness. It may be the look, feel, comfort, durability or the output of its use.
Unlike engineering goods there is nothing like after-sale service, warrantee or guarantee period for food and drugs.

9. Hospital pharmacy series- A case for National Medication Policy

Submitted by Bhagavan P S on Mon, 12/21/2009 - 11:34

What we use is Not used by others.

'India has approved some drugs that are not approved by US FDA.

There are list fo drugs circulating on the net in shouting fonts that 'banned rugs available, Killer drugs in market etc...

Unfortunately we don't have a common global medication policy, though it is ideal to have one.

8. Hospital pharmacy series - Dosage

Submitted by Bhagavan P S on Tue, 12/15/2009 - 15:13

1 - 1 - 1.

1 - 0 - 1

0 - 0 - 1

I welcome all the pharmacy students and teachers to explain and discuss this dosage instruction.

Clue - 1. PL KEEP IN MIND ALL CATEGORY OF PEOPLE.

Good wishes
bhagavanps

CLUE - 2:

The responses are good and your understanding is as per the subject taught and read in books.

This happened some where in early 1980s;

FDA's Safe Use (Drug) Initiative pt.1

Submitted by Nik on Sat, 12/05/2009 - 19:31

Tens of millions of people in the United States depend on prescription and OTC medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, and some die as a result of preventable medication errors.The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community.

3. Hospital pharmacy series - a case of a Drug survey for patient safety

Submitted by Bhagavan P S on Sat, 12/05/2009 - 09:09

Sub: I M A survey on Nemuselide

Well, with due regards and respect to the ethical practitioners, I for one do not trust the IMA survey for the simple reason that no records / documents would be available at the doctors level to back check the veracity of the opinion.