The Fundamentals of Clinical Research. P. Michael Dubinsky

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211 requirements in the earliest stages of clinical testing but that leeway starts to evaporate once Phase II begins and by Phase III of clinical testing of a new drug the manufacture of the investigational drug product is expected to be in full compliance with 21 CFR 211. Whether that is always the case may be up for debate since the FDA from a programmatic standpoint does not routinely or programmatically inspect the manufacture of new drugs being used in clinical trials. That said if the FDA were to find that an investigational drug product was not being manufactured in conformance with applicable cGMP or was adulterated or misbranded they can and will act to contain its use if the responsible firm does not do so.

      3.2.5 Common Properties of GXPs

      So what is it that ties the three GXP disciplines together? It is the culture of quality and building quality into all aspects and processes that are employed. If you turn to Chapter 30 and the diagram depicting the quality management system you can visualize that whether the investigational product is being manufactured, undergoing preliminary testing to assess its toxicity, or being administered to humans as part of a clinical trial the same set of quality characteristics are brought to bear.

      Once a firm has decided to pursue a drug development process it enters a regulated environment which includes GLP, GCP, and cGMP. The plans, actions, and decisions associated with the firm’s drug development initiative must be in tune with and guided by these regulatory requirements. GCP is a part of the regulatory scheme not the entire regulatory scheme.

      Knowledge Check Questions

      1 GXP refers to what three regulatory concepts?

      2 Repurposing of a drug is one approach to drug development. True or False

      3 A drug being used in a Phase I study must meet all cGMP requirements according to FDA. True or False

      4 Post approval prescribing of drug products is governed by state and local officials. True or False

      5 ICH E6(R2) Is a regulatory requirement in the United States. True or False

      1 1 Repurposing existing drugs for new indications. 1 January (2017). https://www.the‐scientist.com/features/repurposing‐existing‐drugs‐for‐new‐indications‐32285?archived_content=9BmGYHLCH6vLGNdd9YzYFAqV8S3Xw3L5 (accessed 27 January 2020)

       P. Michael Dubinsky

      GCP Key Point

       GCP expectation intersects the entire functional scheme of clinical development for pharmaceutical medicinal products. Understanding the intersections is useful and enlightening.

      The emergence of the ICH closely parallels with the emergence of current GCP because the ICH served as a catalyst for development of Standards such as the ICH E6(R2). The ICH‐GCP (R1) was one of the first standards developed by the ICH. It was recognized that such a standard was needed. Regulatory Authorities had worked on building the GCP expectations into their regulatory schemes by detailing them in codes or regulations then interpreting the codes using mechanisms such as inspections and industry meeting presentations. The World Health Organization (WHO) had pursued developing principles of good clinical research practice as early as the late 1960s however the WHO was not a regulatory or standard setting organization so their guidance did not represent requirements nor was it mandated under any laws. The regulatory authorities were not working collaboratively to further their GCP thinking and as a result the requirements across countries and regions were evolving differently. It took an industry‐regulatory authority initiative – The ICH – to open the door to establishing a pathway for harmonization of GCP as well as other drug development requirements. That initiative has flourished and expanded.

      In Chapter 1 – History of GCP outlines key aspects of the birth of the ICH organization and its growth from 1990 to the present day. This chapter will not repeat that material but rather will outline how the ICH E6(R2) reflects the harmonized expectations of the industry‐regulatory authority collaboration which began working to draft the GCP Efficacy Guideline almost immediately after the establishment of the ICH as an organization.

      The objectives of this chapter are to:

       Demonstrate how the ICH E6(R2) Guideline serves to underpin those practices which support subject safety and data integrity within the context of meeting regulatory authority requirements.

       Outline several ways the ICH guideline elements moved the conduct of clinical trials closer to meeting the expectation of regulatory compliance and best practices.

      Since this text is devoted to explaining fundamental precepts for good clinical practice this chapter will not address each topic area but rather select several examples of how the ICH E6(R2) moves clinical research several steps higher than the regulatory expectations which are generally acknowledged to be the minimum requirements for compliance with a statute, directive, or code.

      The thirteen

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