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Friday, July 9, 2010


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New Topics

A short introduction from the discussion groups
E7(R1)Studies in Support of Special Populations: Geriatrics
The Concept Paper available here
A Questions & Answers document will be developed to provide further guidance on the E7 Guideline.
The essential elements for inclusion of elderly patients in clinical studies are outlined in the current ICH E7 guidance document. ICH E7 notes that for drugs with significant use in the elderly, the inclusion in clinical trials of a minimum of 100 patients aged 65 years or older "would usually allow detection of clinically important differences" in drug responses compared with younger patients.
However, with the increasing prevalence of elderly and very elderly in the society and in view of the recent advances in clinical science and clinical trials experience build over the last 15 years, this number may no longer be adequate.
Read more
Q11Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities)
The Concept Paper available here
A new tripartite Technical Guidance is proposed for Active Pharmaceutical Ingredients (APIs harmonising the scientific and technical principles relating to the description and justification of the development and manufacturing process (CTD sections S 2.2. - S 2.6) of Drug Substances including both chemical entities and biotechnological/biological entities.
This document will take into consideration and provide examples as appropriate for describing the principles and concepts which are included in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10). However, the approaches to, and extent of, development (e.g., traditional/empirical or systematic/enhanced) will be based on the development strategy designed by each manufacturer.
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S6(R1)Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
The Concept Paper available here
A clarification (and sometimes amplification) of this guidance is needed as substantial experience and new information has been gained since Step 4 (1997). The Nonclinical Safety Experts involved in ICH in S2/S9/M3 agreed that the flexible and case-by-case approach described in the original guidance is still valid and must be preserved.
Disharmony across regulatory regions was identified to be a result of differences in implementation and interpretation of the S6 guidance and in part because of regional specific Points to Consider (PTC) document.
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E16Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions
The Concept Paper available here
This concept paper supports a proposal for a new harmonized ICH guideline on important aspects for the qualification of PG biomarkers. In particular, this new guideline will provide recommendations on the collection of data to support the qualification of PG biomarkers, including
how to define the qualification context and the claims for intended use,
standard methods for data collection,
formats for submission of data to regulatory authorities.
Read more


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