Modelling process and outcomes in complex interventions
David A. Richards, Ingalill Rahm Hallberg in Complex Interventions in Health, 2015
This is a crucial step as it makes the intervention work. Clinical activities are grouped based on their clinical coherence (e.g. measurement of basal metabolic index, advice on malnutrition and supplementary nutrition are clustered into a nutrition key intervention), the performance by a specific team member (e.g. breathing exercises and positioning by the physiotherapist) and time constraints (e.g. all activities regarding discharge management). In the COPD study, the 77 initial clinical activities were grouped into 38 key interventions, categorized into three core processes (diagnostic, pharmacological and non-pharmacological management). All these interventions were mapped into a process flow diagram. An example of a process flow for CABG (Berry et al., 2009) is given in Figure 12.1. The design of the ‘ideal’ process flow is carried in brainstorming sessions within the core team and the wider working group. Current process flows can be observed where it might be helpful to discuss and understand variations. What is seen is that each discipline has a reasonable understanding of the processes in their area, but not how the entire process is interlocked. A process flow diagram helps to understand the interdependency of all actors involved.
Quality by Design (QbD) Principles in the Development of Transdermal Drug Delivery Products
Tapash K. Ghosh in Dermal Drug Delivery, 2020
Once the formula is optimized, the next step is to develop and optimize the manufacturing process. A layout of a commercial manufacturing process is outlined with due diligence paid to the intended scale of manufacturing. The selection of a manufacturing process greatly depends on both product design, scale of manufacture and equipments used. A general process flow diagram involved in the development of TPS is depicted in Figure 5.6. A typical unit operation involved in TPS manufacturing involves a set of critical process parameters (CPPs) that may potentially influence the CQA of the finished product when varied within the operating range. For instance, liquid mixing is an important step in the manufacture of “drug-in-adhesive” TPS that would determine drug content uniformity (quality attribute) of the finished product. Various process parameters and Process Analytical Technology (PAT) involved in the liquid mixing stage are pictorially represented in Figure 5.7. In addition, detailed process parameters involved in the entire manufacturing process of “drug-in-adhesive” TPS and effective control strategies based on PAT tools are depicted in Table 5.8.
Radiation Protection Programs
Michael Pöschl, Leo M. L. Nollet in Radionuclide Concentrations in Food and the Environment, 2006
A typical process flow diagram begins with the delivery and receipt of the radiation source. Laboratories should be designed so that sources are received in a controlled area that is away from normal operations. Keeping the source receipt area away from normal operations prevents the possibility of facility contamination if a package is found to be leaking and minimizes the impact of background radiation levels that can adversely impact sensitive radioanalytical procedures. Since some sources may arrive in heavy shipping containers, or may be in various forms of environmental media, consideration must be given to material handling aspects, such as the use of carts or lifts. Upon receipt, the radiation source must be characterized and inventoried so that a complete accounting of the radiation sources present at any time can be maintained. During the receipt phase, consideration must be given to the radiological monitoring of the transport package to verify integrity. Provisions for interim storage of any source must be made so that the source is properly secured and maintained in appropriate environmental conditions. For example, some samples may need to be maintained in a frozen state, whereas others may need to be maintained at room temperature conditions at all times. Other samples may hold the possibility of offgassing either potentially hazardous gases or nuisance odors, which may warrant the need for storage with local exhaust ventilation. All of these types of requirements should be anticipated prior to the initiation of activities.
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.
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.
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.
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