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Extrusion/Spheronization as a Granulation Technique
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
The process flow diagram, shown in Figure 12.2, has been used by R.E. O’Conner et al. to show each of the process steps along with critical variables associated with them [41]. The end product from each of the steps is shown in Figure 12.3.
Design, Development, Manufacturing, and Testing of Transdermal Drug Delivery Systems
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
Timothy A. Peterson, Steven M. Wick, Chan Ko
Typical process flow diagrams for the manufacture of each patch design are shown in Figure 4.18. Each major unit operation is shown as a separate step. The following are brief definitions of each unit operation, as they apply to transdermal manufacturing:
Reducing risk and promoting safety in primary care
Published in Tim van Zwanenberg, Jamie Harrison, Sir Michael Rawlins, Clinical Governance in Primary Care, 2018
Failure analysis typically draws on tools and techniques that belong to the armamentarium of continuous quality improvement.10,11 These approaches are new to many in healthcare, but are gaining ground fast. Process flow diagrams can be drawn to help us to understand how patients, materials or information move between compartments in the healthcare process. Cause-and-effect charts can help health workers to understand the causes of problems that might occur during the delivery of care. Matrix graphs can be used to prioritise areas that require immediate attention, by flagging errors that have a high risk of occurrence and/or potentially serious implications for patients.
Effects of oral contraceptive for different responder women before GnRH antagonists: a systematic review and meta-analysis
Published in Gynecological Endocrinology, 2021
Jie Li, Yan Sun, Sien Mo, Shujia Wang, Weiwei Luo
In total, 578 articles were collected from the PubMed, EMBASE, and CNKI databases. Thirty studies remained to be assessed in detail after screening the titles and abstract. After evaluating the full text carefully, 15 articles were excluded for the following reasons: 9 studies did not provide valid data or not concrete data collection; 2 were focused on comparing the COH protocols for infertility women; and 4 were reviews, reports, or conferences. Finally, 15 studies [16,18,24–36] containing 5326 participants were eligible. The process flow diagram of selected studies is presented in Figure 1. Comparing the effectiveness of a GnRH-ant protocol with or without oral contraceptive pretreatment on the pregnancy outcomes in ART, six RCTs [18,24,33–36,] and nine case-control studies [16,25–32] were analyzed. Pretreatment group was offered with oral contraceptives for 21–25 d to induce menstruation. The characteristics of the included studies were summarized in Table 1.
Approval of biosimilars: a review of unsuccessful regulatory filings
Published in Expert Opinion on Biological Therapy, 2021
Anurag S. Rathore, Hemlata Chhabra, Ankita Bhargava
EMA Journey: In 2017, the sponsor filed the application of Fulphila to obtain market authorization as a biosimilar to Neulasta to EMA. Upon reviewing the application, the major objections were raised by the EMA including GMP compliance and chemical and biological aspects [26]. The GMP compliance was lacking for both the drug substance and drug product manufacturing sites.The defined acceptance limits for purity and impurity for drug substance and drug product were deemed as too wide to claim biosimilarity with the reference product Neulasta.Inadequacies related to the manufacturing process of drug substance and drug product including in-process controls and controls of intermediates were identified. The process flow diagram was requested. The characterization data for process intermediate and for HCP and DNA depletion were requested from the applicant.Another major objection was deficient control strategy around sterile filtration of the finished product, raising concerns about the sterile operation of drug product facility.
Rationale utilization of phospholipid excipients: a distinctive tool for progressing state of the art in research of emerging drug carriers
Published in Journal of Liposome Research, 2023
Koilpillai Jebastin, Damodharan Narayanasamy
A complete process flow diagram and a description of unit operations should be included in the specification, along with ranges for process parameters and process controls. The procedure and mechanism of liposomal drug loading, as well as the removal of free (unincorporated) drugs from the liposome formulation, should be thoroughly documented. Before commercial distribution, the manufacturing process should be tested to ensure consistency and reproducibility. Changes in production conditions, especially changes in scale (size of the batches), can affect liposome drug products. During product development, appropriate process controls should be established.