Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

Implementation of Plasma Fractionation in Biological Medicines Production

Context:  The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War.  Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries.Evidence Acquisition:  The complexity of the bloo...

An Overview on Probiotics as an Alternative Strategy for Prevention and Treatment of Human Diseases

Aims: Probiotics are viable and useful microorganisms, which are beneficial factors for human and animal health by altering their microbial flora. Most of the probiotics belong to a large group of bacteria in the human gastrointestinal tract. There are several clinical shreds of evidence that show anti-carcinogenic effects of probiotics through altering digestive enzymes, inhibition of carcinog...

An Overview on Probiotics as an Alternative Strategy for Prevention and Treatment of Human Diseases

Aims: Probiotics are viable and useful microorganisms, which are beneficial factors for human and animal health by altering their microbial flora. Most of the probiotics belong to a large group of bacteria in the human gastrointestinal tract. There are several clinical shreds of evidence that show anti-carcinogenic effects of probiotics through altering digestive enzymes, inhibition of carcinog...