Trees whose isoprene production was genetically suppressed “did not suffer ill effects in terms of photosynthesis or ‘biomass production.’”They produced cellulose, (used in biofuel production) and grew as well as trees that were not modified. Because isoprene has a protective effect in stressful climates, the results were surprising. “The suppression of isoprene production triggered alternative […]
The insensitivity of FPD to shifts in inhaler APSD is illustrated and underlying causes have been discussed. Data from eight different products are examined. In conclusion, FPD cannot be used alone as a metric for APSD quality control. FPD can be used to control the mass-dimension of the APSD, but must be used in conjunction […]
The findings provide an overview of patient-reported levels of access to prevention, diagnosis, care and empowerment. In addition, the report provides recommendations for healthcare providers and systems, policy makers and payers, as well as patients and researchers.
It is inevitable that small- and medium-sized pharmaceutical companies outsource key research and chemistry, manufacturing and control (CMC) functions to contract research organizations (CROs) when it does not make financial sense to build internal capabilities for activities that are infrequent and/or require large capital or headcount investments to establish expertise. For inhalation product development, there […]
The authors provide a brief history of dry powder inhalers then discuss considerations for future development such as formulation, dose storage, moisture protection and metering, de-aggregative processes, counters, the environment, patient considerations and non-respiratory indications.
In this article, we look at recent changes in the regulatory framework, summarizing changes in United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, the pharmacopeias, and in localized regulations from regions of growing importance for drug development and manufacture, such as Brazil and China.
The author suggests opportunities exist in treating additional diseases, getting involved with patients, determining aerodynamic particle size distribution, managing oropharyngeal deposition, improving nasal delivery and targeting orally inhaled products with narrow therapeutic indices.
The US Food and Drug Administration (FDA) issued a statement in support of their decision, with explanatory and cautionary information. At the same time, a joint statement against the approval was issued by multiple asthma patient advocacy groups and community stakeholders saying, in part, that the groups “believe the FDA’s decision endangers people with asthma […]
As with standard solid dosage forms, commercial DPIs are typically labeled with a label claim, which, in simple terms, is essentially the strength or dose of the product. For DPIs, however, the understanding of dose is more complex than for standard solid dosage forms because the entire labeled dose never reaches the target region of […]
This article focuses on the informative chapters that are either official text or are in draft, and fall under the remit of the sub-committee: <1601>, <1602>, <1603> and <1604>. The information provided on draft chapters and is based on previously published Stimuli articles, and should therefore be construed as only being indicative of likely content, […]