China
Africa
Explore chapters and articles related to this topic
Regulatory Issues in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
The pharmaceutical industry today is facing many challenges. The cost of drug research has increased steeply, and at the same time, R&D productivity is waning. Patent expiry and loss of exclusivity are resulting in decreasing revenues. Manufacturers are thus being forced to improve efficiencies and reduce costs. This is affecting the way manufacturing is carried out, with greater emphasis on the use of science-based tools and quality risk management to improve operational performance and to focus on elements that are critical to product quality.
Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
The use of UL and OL medicines does not imply poor medical or pharmacy practice, it is done when there is no alternative. European legislation makes provision for doctors to prescribe, pharmacists to dispense and nurses to administer UL and OL medicines [4]. Licensing principally regulates the pharmaceutical industry in their marketing of drugs.
Introduction
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray
As with other sectors of the economy, the U.S. pharmaceutical industry is undergoing profound changes that influence how it develops and markets products. These changes have come about in response to a number of factors including the globalization of the pharmaceutical industry and its markets, the consolidation of the U.S. Health Care industry, the explosive growth of managed care arrangements, and greater sophistication on the part of the People.
Are patents important indicators of innovation for Chagas disease treatment?
Published in Expert Opinion on Therapeutic Patents, 2023
Andrea Pestana Caroli, Felipe R. P. Mansoldo, Veronica S. Cardoso, Celso Luiz Salgueiro Lage, Flavia L. Carmo, Claudiu T Supuran, Alane Beatriz Vermelho
Several bottlenecks are found and discussed in several reviews of literature, such as lack of investments from the government, the low interest of the large pharmaceutical laboratories despite the growing participation, difficulties in the translational processes, and lack of integration between academia and industry for the development of clinical studies are among the main factors [106–109]. For neglected diseases, the economics of developing a drug is unfavorable. Due to this low investment in drugs to treat diseases predominantly in low- and middle-income countries, the pharmaceutical industry invests in market drugs. According to Lexchin, 2021 [110], in 2000 and 2011, 336 new chemical entities were registered worldwide, and only four were approved for neglected diseases. In addition, 1% of the 148,445 clinical trials registered at the end of 2011 were focused on neglected diseases [111].
Repurposing of atorvastatin emulsomes as a topical antifungal agent
Published in Drug Delivery, 2022
Alaa S. Eita, Amna M. A. Makky, Asem Anter, Islam A. Khalil
In the pharmaceutical industry, establishing a new drug is a complicated, costly, and time-consuming process. According to the food and drug administration (FDA), the drug development process generally undergoes four stages before marketing including discovery and development, preclinical, and clinical research. FDA reviews all those stages over 12–15 years (Hughes et al., 2011). A new strategy termed drug repurposing ‘repositioning’ was useful to overcome the lengthy drug discovery process. Repurposing implies the ability to investigate new therapeutic uses for previously approved drugs with different utilization scopes (Pushpakom et al., 2019). Recently, this strategy is widely used effectively in oncology, cardiology, mycology, and other diseases (Peyclit et al., 2021). Many drug classes were investigated for antifungal efficacy, and chosen as useful alternative common drugs (Miró-Canturri et al., 2019; Kim et al., 2020).
A narrative review on drug development for the management of antimicrobial- resistant infection crisis in Japan: the past, present, and future
Published in Expert Review of Anti-infective Therapy, 2022
Takahisa Ohashi, Masahito Nagashima, Nobuko Kawai, Norio Ohmagari, Kazuhiro Tateda
One of the reasons for the withdrawal of large pharmaceutical companies from new antimicrobial development is the unfavorable cost-profit balance. To overcome the financial challenges faced by the industry, key stakeholders in Japan have made several recommendations, including the introduction of incentive programs [84,85]. However, to revolutionize this situation, involvement of various stakeholders outside of the pharmaceutical industry, such as the government, regulatory bodies, and healthcare providers – especially, proactive actions by the national government – would be required. From the regulatory perspective, international harmonization of drug development processes and regulatory requirements has long been discussed between the pharmaceutical industry and regulatory agencies of various countries. These discussions have been particularly active in the development of anti-infective therapies, including antimicrobial agents [28]. Global harmonization of regulatory requirements for antimicrobial agents will help the industry to develop novel and effective therapeutic options for AMR in a timely manner and eliminate the ‘drug lags’ [34]. In addition, Japan’s leading role in establishing clinical trial networks in Asia and conducting multinational clinical trials for antimicrobial agents is expected.