The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.

For several years, the United States Food and Drug Administration (FDA) has participated in a collaborative effort to harmonize the technical procedures for development and regulatory approval of human pharmaceuticals in multiple countries. This harmonization effort is the work of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). At this point, ICH focuses on achieving harmonization of technical requirements in three major regions of the world, i.

Dose-response study of inhaled salmeterol in asthmatic patients with 24-hour spirometry and Holter monitoring.

Salmeterol is a new long-acting beta 2-selective adrenoceptor agonist. In this double-blind, 6-way crossover study, four single doses of salmeterol by metered dose inhaler (12.5, 25, 50, 100 micrograms) were compared with albuterol aerosol 200 micrograms and placebo in 24 patients with moderate asthma with 24-hour pulmonary function testing and Holter monitoring.

Use and acceptance of ventolin Rotacaps and the Rotahaler in 1235 asthmatic patients.

This open-label study was performed to characterize the acceptance, reliability, and adverse event profile of a dry powder delivery system for albuterol. A total of 1235 asthmatic outpatients, aged 11 to 84 years, were studied for 1 month. Each patient enrolled was documented as having a specific complaint concerning the use of a standard metered-dose inhaler.

Improved stability in oral delivery of albuterol provides less variability in bronchodilation in adults with asthma.

The objective of this randomized, single-blind, parallel group study was to determine whether a more constant rate of albuterol delivery from tablets provides less variability in bronchodilation. Thirty-eight adult patients were enrolled with FEV1 between 40% to 80% of predicted normal and greater than or equal to 15% reversibility. Eighteen patients received Volmax, 8 mg bid, and 20 patients received Proventil Repetabs, 8 mg (as two 4-mg tablets) bid.