A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery

“This is an Accepted Manuscript of an article published by Taylor & Francis Group in COPD: Journal of Chronic Obstructive Pulmonary Disease on 17 Aug 2020, available online: https://doi.org/10.1080/15412555.2020.1797658

Individualizing therapy – in search of approaches to maximize the benefit of drug treatment (II)

Adjusting drug therapy to the individual, a common approach in clinical practice, has evolved from 1) dose adjustments based on clinical effects to 2) dose adjustments made in response to drug levels and, more recently, to 3) dose adjustments based on deoxyribonucleic acid (DNA) sequencing of drug-metabolizing enzyme genes, suggesting a slow drug metabolism phenotype. This development dates back to the middle of the 20(th )century, when several different drugs were administered on the basis of individual plasma concentration measurements. Genetic control of drug metabolism was well established by the 1960s, and pharmakokinetic-based individualized therapy was in use by 1973

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs

Assessing fidelity of delivery of smoking cessation behavioural support in practice.

Effectiveness of evidence-based behaviour change interventions is likely to be undermined by failure to deliver interventions as planned. Behavioural support for smoking cessation can be a highly cost-effective, life-saving intervention. However, in practice, outcomes are highly variable. Part of this may be due to variability in fidelity of intervention implementation. To date, there have been no published studies on this. The present study aimed to: evaluate a method for assessing fidelity of behavioural support; assess fidelity of delivery in two English Stop-Smoking Services; and compare the extent of fidelity according to session types, duration, individual practitioners, and component behaviour change techniques (BCTs)