WHO has recently released a guideline for performing in vivo bioequivalence studies (WHO Technical Report Series 996, 2016). The guideline mainly emphasizes on the subject safety, including data integrity. The objective is to provide guidance to the CROs that are involved in conduction and analysis... Read More
Nutraceuticals are the products that have both nutritional and pharmaceutical characters. Therefore they are used as a dietary supplement to modulate the symptoms of various diseases and conditions by providing physiological benefits against chronic diseases.
Due to higher consumer acceptability in the US and Japan, these... Read More
Drugs used in therapeutic treatments have associated potential risks for adverse events (AE). Nevertheless, medical practitioners acknowledge such risk and take appropriate precautions while prescribing the drug. Besides that, there are also higher chances of AEs in patients due to lack of awareness. To minimize... Read More
Developing and launching a new pharmaceutical drug to the market is an immensely expensive operation. Pharmaceutical scientists and physicians are constantly engaged in research to find the best ways to diagnose and treat disease; with focus on the 'Risk vs. Benefit ratio'(always trying to see... Read More
The guidance covers major amendments; the points regarding the clinical study part are mentioned below:
The CRF should be sent to the IEC for review and approval together with the study protocol, if it is not part of the protocol.
Subject’s Entry and Exit to the facility... Read More