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QbD and PAT in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has advanced pharmaceutical QbD with the issuance of ICH Q8 (R2) (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) guidance [3–5]. Additionally, ICH Q1WG on Q8, Q9, and Q10 Questions and Answers; the ICH Q8/Q9/Q10 Points to Consider document; and ICH Q11 (Development and Manufacture of Drug Substance) have been issued, as having the conclusions of FDA-EMA’s harmonization and parallel assessment of QbD elements of marketing applications [6–9]. These documents provide high-level guidelines concerning the scope and definition of QbD as it applies to the pharmaceutical industry. But there is confusion among industry scientists-technocrats, academic professors-students, and regulators despite recent publications for implementation of QbD. This chapter is projected to describe the objectives of pharmaceutical QbD in detail, its concept, and elements along with tools and tactics for implementation.
Analytical Method and Assay
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the pharmaceutical industry and medicines regulatory authorities of Europe, Japan and the United States. It defines quality as “the suitability of either a drug substance or drug product for its intended use” and has published guidance for the pharmaceutical industry that defines the concept and application of QbD: “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” To this end, QbD concepts are well defined in the ICH guidelines Q8(R2): Pharmaceutical development; Q9: Quality risk management; and Q10: Pharmaceutical quality system (ICH Q8, 2009; ICH Q9, 2005; ICH Q10, 2008), furthermore, FDA’s cGMP for the 21st Century (U.S. Food and Drug Administration, 2009), and Process Analytical Technology (PAT) (U.S. Food and Drug Administration, 2004) guidance support the implementation of QbD concepts.
Nonclinical Safety Evaluation of Drugs
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
Thomas M. Monticello, Jeanine L. Bussiere
The regulatory authority for pharmaceutical development and marketing approval in the United States is the US Food and Drug Administration (FDA: http://www.fda.gov); in the European Union, the European Medicines Agency (EMA: http://www.ema.europa.eu); and in Japan, the Ministry of Health, Labor, and Welfare (MHLW: http://www.mhlw.go.jp/english). These three regions work together to harmonize the nonclinical safety requirements as part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, the ICH has gradually evolved to respond to the increasingly global face of drug development. The ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. The reader is encouraged to visit these and other regulatory websites for more detailed information (http://www.ich.org).
New perspective to develop memantine orally disintegrating tablet formulations: SeDeM expert system
Published in Pharmaceutical Development and Technology, 2018
Sıla Gülbağ, Duygu Yılmaz Usta, Hazal E. Gültekin, Ayşe N. Oktay, Özden Demirtaş, Alptuğ Karaküçük, Nevin Çelebi
In recent years, regulatory health authorities such as the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have focused on the development of new formulation strategies in order to save time and due to high production costs. ICH Guideline Q8 on Pharmaceutical Development and Quality by Design (QbD) insight (ICH Expert Working Group 2009) is one of the most important fields for these purposes.
A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years
Published in Modern Rheumatology, 2021
Tsutomu Takeuchi, Yoshiya Tanaka, Mitsuhiro Rokuda, Hiroyuki Izutsu, Yuichiro Kaneko, Musashi Fukuda, Daisuke Kato
All studies included in this analysis were conducted in accordance with Good Clinical Practice, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, and local laws and regulations. The study protocols and amendments were approved by an Institutional Review Board at each study site, and safety data were reviewed by the independent Data and Safety Monitoring Board. Each patient provided written informed consent prior to treatment initiation.
Comprehensive analysis and prediction of long-term durability of factor IX activity following etranacogene dezaparvovec gene therapy in the treatment of hemophilia B
Published in Current Medical Research and Opinion, 2023
Jinesh Shah, Hongseok Kim, Krupa Sivamurthy, Paul E. Monahan, Michael Fries
The population used in this analysis consists of all participants treated with etranacogene dezaparvovec in clinical trials including the Phase 2 b (N = 3; NCT03489291)4,6 and Phase 3 (N = 52; NCT03569891) studies7, with the exception of two participants who did not respond to treatment and continued to receive prophylactic factor IX replacement products (one participant received only a partial dose of etranacogene dezaparvovec, the other participant had a notably high AAV5 neutralizing antibody [NAb] titer of 3212)7. Full inclusion/exclusion criteria for both trials are listed in the supplementary material (Table S1; Table S2). The two study populations were naively pooled and the combined set of 55 participants was used for statistical modeling and is referred to as the analysis population (Figure 1). Details on constructing the analysis data are provided in the supplementary material. Regarding the two clinical trials, ethical approval has been obtained from the appropriate local Independent Ethics Committee (IEC) or Institutional Review Board (IRB) and informed consent has been obtained from all participants. All IECs and/or IRBs reviewed and approved the protocols prior to study initiation. All protocol amendments, informed consent form documents, relevant supporting information, and written study materials were also approved prior to their use. These trials are conducted in accordance with current applicable regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) (E6[R2]), European Union (EU) Directive 2001/20/EC, EU Directive 2005/28/EC, Food and Drug Administration (FDA) of the United States (US) guidelines, Advanced Therapy Medicinal Products (ATMP) guidelines and its updates (ENTR/F/2/SF/dn D(2009) 35810), and local ethical and legal requirements.