What is ICH S7A?

What is ICH S7A?

S7A – S7B Pharmacology Studies The ICH Harmonised Guideline was adopted under Step 4 in November 2000. This document provides a definition, general principles and recommendations for safety pharmacology studies. This Guideline generally applies to new chemical entities and biotechnology-derived products for human use.

What is the difference between safety pharmacology and toxicology?

The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug’s adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events.

What is core battery test?

The purpose of the safety pharmacology core battery program is to investigate the effects of the test substance on vital functions. In this regard, ERBC conducts GLP-compliant studies on central nervous, respiratory and cardiovascular systems in small and large animal species.

What do safety pharmacology studies of the investigational product examine?

For the purpose of this document, safety pharmacology studies are defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.

What are ICH guidelines?

ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

Which are the four ICH guidelines?

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.

  • Quality Guidelines.
  • Safety Guidelines.
  • Efficacy Guidelines.
  • Multidisciplinary Guidelines.

Which of the following three key systems are evaluated in safety pharmacology studies?

The purpose of the safety pharmacology core battery is to investigate the effects of the test substance on vital functions. In this regard, the cardiovascular, respiratory, and central nervous systems are usually considered the vital organ systems that should be studied in the core battery.

Under which condition safety pharmacology study is necessary?

Safety pharmacology studies are required to be completed prior to human exposure (i.e., Phase I clinical trials), and regulatory guidance is provided in ICH S7A and other documents.

For what ICH q1 guidelines are?

The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.