Purpose of Bioavailability Studies | Book Excerpt

Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.

Bioavailability studies are performed for both approved active drug ingredients and therapeutic moieties not yet approved for marketing by the FDA. New formulations of active drug ingredients must be approved by the FDA before marketing. In approving a drug product for marketing, the FDA ensures that the drug product is safe and effective for its labeled indications for use. Moreover, the drug product must meet all applicable standards of identity, strength, quality, and purity. To ensure that these standards are met, the FDA requires bioavailability/pharmacokinetic studies and, where necessary, bioequivalence studies for all drug products (FDA Guidance for Industry, 2003). Bioavailability may be considered as one aspect of drug product quality that links in-vivo performance of the drug product used in clinical trials to studies demonstrating evidence of safety and efficacy.

India is flooding the world with tainted drugs - and getting away with it | Foreign Policy

This article was first published on Foreign Policy News on 4th October. This is just a magnet part of the article, if you want to read the full article, you must have to visit their website here.

BAD MEDICINE

(By Roger Bate) Each time we take medicine, we assume that the manufacturer did its best to produce a quality product. Evidence is mounting, however, that some pharmaceutical manufacturers in countries like India cut corners and send low-quality products to major, developed markets. Worse still, they may have separate production lines for drugs they sell in developing markets like Africa, where poor quality is more likely to go unnoticed.

In mid-2013, India's largest drugmaker, Ranbaxy, pleaded guilty in a U.S. court to several criminal offenses relating to the fraudulent manufacture and sale of adulterated drugs. (The United States is the biggest importer of generic Indian drugs.) Among other revelations, Ranbaxy's executives acknowledged that "more than 200 products in more than 40 countries" are affected by "elements of data that were fabricated to support [Ranbaxy's] business needs." In other words, Ranbaxy made up facts and figures to demonstrate product safety for myriad drugs, including critical HIV medicines paid for by U.S. tax dollars and destined for the poor in Africa. As a consequence, the company was fined $500 million.

The Indian government, protective of its country's $20 billion pharmaceutical industry, quickly responded by claiming that Indian drugs are in fact safe. But in September, the U.S. Food and Drug Administration banned imports of drugs from another Ranbaxy plant that had not been implicated in the recent settlement.

Pharmaceutical Industry Article: In vitro Dissolution Profile acts as a Pre-assessment Tool for Bioequivalence Study of Generic Pharmaceutical Oral Solid Products.

About Author: This article was Exclusively Written for Pharma Mirror Readers by Mohammad Dulal, Industrial Pharmacist licensed in MOH/Dubai, Senior Scientist, Product Development Lab, Julphar Gulf Pharmaceutical Ltd, Ras Al Khaimah, United Arab Emirates.

1.0 Introduction

Generic pharmaceutical products are clone of innovator products in the term of actives, strengths, dosage forms, dosage regimens and administrations. Actual fact is that innovator companies are very less in numbers in the world due to requirement of huge investment. Innovator companies are also not in good numbers enough to serve their medicines to all the worldwide patients. Reasonably, generic companies are established to serve their local patients with medicines at a manageable price. Generic companies cannot

Pharmaceutical Industry Poem: Quality and Productivity | Pharma Mirror Magazine

Where there is safety there is Quality.

Meeting indication is Quality.

Fitness for use is Quality.

Rational interaction is Quality.

Get the job right the first time is Quality.

Less adverse effect is Quality.

Customer’s satisfaction is Quality.

Defect free is Quality.

In-process control is Quality.

Statistical control is Quality.

Control within range/ limit is Quality.

Execution of jobs as per SOPs is Quality.

Validated process is Quality.

Validated environment is Quality.

Vigilance supervision is Quality.

Continuous improvement is Quality.

Stepwise work is Quality.