PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 10474140

Emerging and recurrent issues in drug development.

C Anello
View original source ↗Export metadata ↓

Abstract

This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodology. Recurrent issues include: renewed interest in statistical methods for handling subgroups in the design and analysis of clinical trials; renewed interest in alternatives to the 'intention-to-treat' analysis in the presence of non-compliance in randomized clinical trials; renewed interest in methodology to address the multiplicities resulting from a variety of sources inherent in the drug development process, and renewed interest in methods to assure data integrity. These emerging and recurrent issues provide a continuing challenge to the international community of statisticians involved in drug development. Moreover, the involvement of statisticians with different perspectives continues to enrich the field and contributes to improvement in the public health.

Explore related subjects

Computer-Aided DesignDrug ApprovalDrug DesignHumansMeta-Analysis as TopicTreatment RefusalUnited StatesUnited States Food and Drug AdministrationJournal ArticleReview

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

C Anello. Emerging and recurrent issues in drug development.. https://doi.org/10.1002/(sici)1097-0258(19990915%2F30)18%3A17%2F18%3C2301%3A%3Aaid-sim256%3E3.0.co%3B2-x

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2007

Optimization of a jet-propelled particle injection system for the uniform transdermal delivery of drug/vaccine.

A jet-propelled particle injection system, the biolistics, has been developed and employed to accelerate micro-particles for transdermal drug delivery. We have examined a prototype biolistic device employing a converging-diverging supersonic nozzle (CDSN), and found that the micro-particles were delivered with a wide velocity range (200-800 m/s) and spatial distribution. To provide a controllable system for transdermal drug delivery, we present a contoured shock-tube (CST) concept and its embodiment device. The CST configuration utilizes a quasi-steady, quasi-one dimensional and shock-free supersonic flow to deliver the micro-particles with an almost uniform velocity (the mean velocity and the standard deviation, 699 +/- 4.7 m/s) and spatial distribution. The transient gas and particle dynamics in both prototype devices are interrogated with the validated computational fluid dynamics (CFD) approach. The predicted results for static pressure and Mach number histories, gas flow structures, particle velocity distributions and gas-particle interactions are presented and interpreted. The implications for clinical uses are discussed.

Computer-Aided Design↗
PubMed2007

A stand-alone peristaltic micropump based on piezoelectric actuation.

Despite significant efforts to develop micropumps, cumbersome driving equipment means that the design of portable micropumps remains a challenge. This study presents a stand-alone micropump system, which includes a peristaltic micropump based on piezoelectric actuation and a driving circuit. This battery-based driving circuit comprises a 12 V battery, an ATmega 8535 microprocessor, a 12 V-to-180 V DC to DC converter using transformerless technology, three differential amplifiers, an IC 7805, a phase controller, an A/D converter, a keyboard and an LCD module. The system can produce step-function signals with voltages of up to 228 V(pp) and frequencies ranging from 10 Hz to 100 kHz, as the inputs for the pump. It is portable and programmable with the package size of 22 x 12.8 x 9 cm. Additionally, this proposed system is used to design the driving signals of the pump which are 3-, 4, and 6-phase actuation sequences. This work performs the circuit testing and fluid pumping, and demonstrates the effects of actuation sequences on pump performance in terms of the dynamic behavior of the diaphragm, flow rates, back pressure and power consumption of the system. The experimental results show that the pump excited by the 6-phase sequence results in better performance compared with the 3- and 4-phase sequences, and produces a maximum flow rate of 36.8 microl/min and a maximum back pressure of 520 Pa with deionized water at 100 V (pp) and 700 Hz.

Computer-Aided Design↗
PubMed2007

Novel transmit protection scheme for ultrasound systems.

The problem of protecting or isolating extremely sensitive receive circuitry from high-voltage transmit circuitry is commonly addressed through the use of diode bridges, transformers, or high-voltage switches, which prove to be prohibitively expensive, bulky, and power consuming for use in portable, low-cost, battery-powered systems. These approaches also compound the interconnect difficulties associated with two-dimensional (2-D) transducer arrays. In this paper we present a novel transmit protection scheme that allows compact MOSFET shunting devices to be brought on-chip within each receive channel implemented in a standard CMOS integrated circuit process. During transmit, the high voltage transmit pulse is driven onto the common connection of the transducer array and the on-chip MOSFET devices shunt the current to ground. During receive, these devices are turned off, the common connection of the transducer array is shunted to ground, and the received echo can be detected as usual. The transmit protection scheme was experimentally shown to shunt a 16 mA peak current resulting from the equivalent of a 100-V, 25-ns-risetime transmit pulse through a 4 pF transducer element. The scheme was also incorporated into a prototype 1024-channel, low-cost, ultrasound system successfully used to form pulse echo images.

Computer-Aided Design↗