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Decontextualised Chinese medicines
Published in Vivienne Lo, Michael Stanley-Baker, Dolly Yang, Routledge Handbook of Chinese Medicine, 2022
Michael Heinrich, Ka Yui Kum, Ruyu Yao
In sum, while in many parts of the world, the uptake and usage of goji is stimulated by the phytochemical and pharmacological evidence, in China traditional TCM theory, and related traditional concepts, promote the consumption of goji. However, there is a convergence developing in the usages between China and beyond. Here again, as with ginseng, we have a journey which transforms goji from a commodity first travelling Westwards and then in a circular flow affecting goji’s use at its origins in China. Within a cultural background that incorporates TCM as one form of regulated therapeutics, goji can be formally accommodated as a Chinese medicine. It can be accepted as a (phyto-) pharmaceutical product, as long as its composition, functions, and safety are demystified and adapted to the existing formal regulatory framework.
Best Practices in Cancer Nanotechnology: Perspective from NCI Nanotechnology Alliance *
Published in Valerio Voliani, Nanomaterials and Neoplasms, 2021
William C. Zamboni, Vladimir Torchilin, Anil K. Patri, Jeff Hrkach, Stephen Stern, Robert Lee, Andre Nel, Nicholas J. Panaro, Piotr Grodzinski
A critical element for successful development and commercialization of any pharmaceutical product is a scalable, reproducible manufacturing process. Besides typical considerations and challenges with scale-up and commercial manufacture, there are additional challenges for nanotechnology-based products for treating cancer. Some of the most critical aspects of the manufacture of cancer nanomedicines include sterility (most will be administered intravenously), nanoparticle size and polydispersity, encapsulation efficiency, removal of free drug, and drug-release rate. In addition, for actively targeted cancer nanomedicines that employ receptor-mediated binding of nanoparticles to tumors, the amount and appropriate surface exposure of targeting ligand must be addressed.
On Drug Prices
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Because we are not privy to the reasoning behind the pricing in this case, it is difficult to evaluate the success of the approach. From this sample, however, we see more high-priced successes than low-priced successes and no high-priced failures. The role of Price in the success of a pharmaceutical product may be more closely related to the firm’s confidence in the product and its ability to market the product than to a physician’s decision to prescribe it.
An update on Alectinib: a first line treatment for ALK-positive advanced lung cancer
Published in Expert Opinion on Pharmacotherapy, 2023
Yourong Zhou, Yiming Yin, Jiangxin Xu, Zhifei Xu, Bo Yang, Qiaojun He, Peihua Luo, Hao Yan, Xiaochun Yang
The most common adverse events in patients with NSCLC treated with alectinib are mild to moderate, including skin and subcutaneous tissue disorders, gastrointestinal disorders, and respiratory disorders. These events can be resolved with symptomatic treatment. The occurrence of serious adverse events is rare. However, the above-mentioned events are the major reason for dose reduction or interruption of treatment. After remission, patients may gradually resume dosing. The adverse events from the four completed phase II and III trials that have been concluded are summarized in Table 2. It is important to note that the adverse events here are any untoward medical occurrence in a participant administered a pharmaceutical product. Serious adverse events are events that require hospitalization, prolong hospitalization, disability, affect work capacity, endanger life or death, or cause congenital malformations that occur during the course of the clinical trial.
Comparative and inducement appeals Rx by drug class
Published in International Journal of Healthcare Management, 2023
This study demonstrates pharmaceutical product marketing offers multi-disciplinary implications to consumers and healthcare marketers with impacts extending beyond healthcare and services industries. Efforts to target products have become more mature over the last 20 years, as DTC advertising has moved from a novelty to strategically directed investments of pharmaceutical marketers. This evolution provides insights not only for the United States and New Zealand where DTC advertising is allowed, but also for Canada and the European Union, where the DTC advertising bans have been challenged. As a result, the engagement of buyers has become more targeted, reflecting societal evolutions in product purchasing (seller awareness of high pricing points, more competition, comparative products, etc.). Unique to advertising, marketers are increasingly presenting cautious messages, merging consumer optimism for solutions with an awareness of cost. These improvements in messaging and targeting suggest the pharmaceutical marketers will remain sensitized to environmental influences (e.g., government restrictions that control pharmaceutical product marketing and its promotional parameters).
Current status and prospect for future advancements of long-acting antibody formulations
Published in Expert Opinion on Drug Delivery, 2023
Puneet Tyagi, Garrett Harper, Patrick McGeehan, Shawn P Davis
Regulatory bodies are also key stakeholders in the acceptance of any new pharmaceutical product. When changing the formulation for an approved product to a long-acting formulation, the regulatory concerns can be grouped into two areas: 1) Issues related to the new formulation; and 2) Issues related to differences between the originally approved formulation and the new proposed long-acting formulation. In the first instance, if the antibody under consideration already has established safety and efficacy data to support its approval, the primary focus will be on the introduction of any new excipients into the formulation. Given that existing excipients such as PLGA polymers may be inappropriate for biologics formulations, novel excipients will need to be considered. Any novel excipients can require regulatory review and approval of a quality dossier that approaches the size and complexity of the biologic itself. This is in addition to the toxicology studies of the excipients required for review. To add to the toxicological studies, any increase in dose beyond the existing dataset will also support studies.