spacer
home > ict > spring 2018 > exponential developments
PUBLICATIONS
International Clinical Trials

Exponential Developments

“The expected exposure in humans at a dose to be given, in comparison to the exposure at which certain effects were observed in animals or earlier in the study in humans, is considered more relevant than the relative dose levels between animals and humans,” claims the first-in-human (FIH) guidance.

In July 2017, the EMA revised its guidance on FIH clinical trials, providing strategies to identify and mitigate risks for trial participants. This article explores how modern clinical study strategies can be utilised in early phase studies to not only satisfy the new regulatory risk mitigation guidance principles, but also incorporate efficiencies in study design and certainty of decision-making. The purpose of this article is not to restate information that has been provided in earlier FIH guidance documents, but to highlight the new recommendations being suggested.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Bradley Joblin has a doctorate from the University of Zurich, Switzerland. Having held senior management and director positions in clinical research at the headquarters of global pharmaceutical companies and smaller biotechnology companies, his experience is in clinical study implementation, early and late phase clinical study design, and clinical development strategy. Brad founded his own company providing clinical study and development advice to the clinical research community including biotech companies and medical research institutes. He joined Q-Pharm at the start of 2017 to offer scientific oversight and management within Q-Pharm, as well as study design and development strategies to clients.
spacer
Bradley Joblin
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Huge CPhI & P-MEC China a direct result of surging manufacturing

Shanghai, 22 July, 2019:CPhI and P-MEC China – organized by China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), Informa Markets, and Shanghai Sinoexpo Informa Markets – saw record numbers of attendees as the pharma market in China continues to grow. The three-day Shanghai event featured 3,200+ exhibiting companies, spanning the entire pharma supply chain, and provides a strong indication of the market’s overall growth patterns and future development.
More info >>

White Papers

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement