Scientific and Technical Aerospace Reports Volume 39 April 6, 2001

20010023264 Department of Health and Human Services, Center for Drug Evaluation and Research, Rockville, MD USA
Guidance for Industry: Waiver of in Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral
Dosage Forms Based on a Biopharmaceutics Classification System
August 2000; 17p; In English
Report No.(s): PB2001-102520; No Copyright; Avail: CASI; A01, Microfiche; A03, Hardcopy
This guidance provides recommendations for sponsors of investigational new drug applications (INDs), new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications who wish to request a waiver
of in vivo bioavailability (BA) and/or bioequivalence (BE) studies for immediate release (IR) solid oral dosage forms. These waivers
are intended to apply to: (1) subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo
BA of IR dosage forms during the IND period, and (2) in vivo BE studies of IR dosage forms in ANDAs. Regulations at 21 CFR
part 320 address the requirements for bioavailability (BA) and BE data for approval of drug applications and supplemental
applications. Provision for waivers of in vivo BA/BE studies (biowaivers) under certain conditions is provided at 21 CFR 320.22.
This guidance explains when biowaivers can be requested for IR solid oral dosage forms based on an approach termed the Biopharmaceutics
Classification System (BCS).
Author
Classifications; Dosage; Regulations; Medical Science
20010023265 Department of Health and Human Services, Center for Drug Evaluation and Research, Rockville, MD USA
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations
October 2000; 29p; In English
Report No.(s): PB2001-102519; No Copyright; Avail: CASI; A01, Microfiche; A03, Hardcopy
This guidance is intended to provide recommendations to sponsors and/or applicants planning to include bioavailability (BA)
and bioequivalence (BE) information for orally adminstered drug products in investigational new drug applications (INDs), new
drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This guidance addresses how to
meet the BA and BE requirements set forth in 21 DFR part 320 as they apply to dosage forms intended for oral administration.
The guidance is also generally applicable to non-orally adminstered drug products where reliance on systemic exposure measures
is suitable to document BA and BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). The guidance
should be useful for applicants planning to conduct BE and BE studies during the IND period for a NDA, BE studies intended
for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDSs and ANDAs.
Author
Dosage; Exposure
20010023266 Centers for Disease Control and Prevention, Atlanta, GA USA
Morbidity and Mortality Weekly Report. Volume 49, Number 43, November 3, 2000: Great American Smokeout
Nov. 03, 2000; 26p; In English
Report No.(s): PB2001-102497; No Copyright; Avail: CASI; A01, Microfiche; A03, Hardcopy
Tobacco use in the US causes approximately 430,000 deaths each year, including an estimated 3000 deaths from lung cancer
among nonsmokers exposed to environmental tobacco smoke (ETS). In addition, an estimated 62,000 coronary heart disease
deaths annually among nonsmokers exposed to ETS. The detrimental health effects of exposure to ETS are well documented and
include, in addition to lung cancer and coronary heart disease among adults, low birthweight and sudden infant death syndrome
from exposure during and after pregnancy and asthma, bronchitis, and pneumonia in children. This report summarizes the 1999
prevalence of current cigarette smoking among adults by state and the proportion of persons who work indoors and who report
that the workplace have smoke-free policies. The findings indicate that in 1999, adult smoking prevalence differed more than twofold
across states and that the proportion of persons who reported that their workplace had an official smoke-free policy ranged
from 61.3 to 82.1%. As the respondents’ level of education increased, they were more likely to report working under a smoke-free
policy.
Derived from text
Exposure; Health; Mortality; Smoke; Tobacco
20010023267 Centers for Disease Control and Prevention, Epidemiology Program Office, Atlanta, GA USA
Morbidity and Mortality Weekly Report, Volume 49, Number 49: National Cholesterol Education Month, August 2000
August 2000; 30p; In English
Report No.(s): PB2001-102496; No Copyright; Avail: CASI; A01, Microfiche; A03, Hardcopy
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