Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “BIOPHARMACEUTICS”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 541 records · Page 30Linked to original sources
PubMed2000

Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics.

OBJECTIVES: To address the questions of whether women should be included in bioequivalence trials and whether dosage adjustment may be needed in women relative to men. METHODS: Sex-related analysis was conducted for 26 bioequivalence studies involving both sexes. A total of 94 data sets [47 each for the areas under the plasma concentration-time curve (AUC) and maximum concentration (Cmax)] were used. ANOVA was performed. Three statistical models were used to estimate population means and intrasubject variability between sexes, as well as sex-by-formulation interactions. Comparisons were made by use of confidence intervals, magnitude of observed differences, and statistical significance (alpha = .05). RESULTS: With some exceptions, intrasubject variabilities were similar for men and women. In about 10% of the data sets (AUC or Cmax), women had significantly higher variability. Although fewer, there were examples with higher variability in men. With a 20 percentage point difference used in the test-over-reference mean ratios between sexes as a signal of sex-by-formulation interaction, the frequency of this interaction (AUC or Cmax) is approximately 13% and approximately 35%, counting by data sets and studies, respectively. Mean sex-related differences of > or = 20% in the pharmacokinetic parameters for the reference product were observed in 39% of the data sets (AUC or Cmax). In approximately 28% of the data sets, these differences were statistically significant. The frequency was approximately 15% after body weight correction. CONCLUSIONS: In general, men and women have similar intrasubject variability. Where variability differs between sexes, there is a suggestion that higher variability in women may be more frequent. The data also suggest that a sex-based subject-by-formulation interaction can occur, although the frequency may be low. Sex-related differences in pharmacokinetics are apparent in many drugs studied. Dosage adjustment with body weight may be warranted for drugs that exhibit a steep dose-response curve. Although exploratory, the results of this study support recommendations of the 1993 Food and Drug Administration gender guideline that women not be excluded from bioequivalence trials.

Adult↗
PubMed1999

Design, development, and biopharmaceutical properties of buccoadhesive compacts of pentazocine.

Buccoadhesive compacts (BCs) of pentazocine (PZ) were prepared by the direct compression method using polymers like carbopol 974P (CP 974P) and hydroxypropyl methylcellulose (HPMC K4M) in ratios of 1:0 (batch B1), 1:1 (B2), 1:2 (B3), 1:4 (B4), and 0:1 (B5). The compacts were evaluated for thickness uniformity, weight variation, drug content uniformity, and swelling index. Swelling was increased with an increase in HPMC K4M content in the compacts. An in vitro assembly was developed to measure and compare the bioadhesive strength of compacts. The maximum bioadhesive strength was observed in compacts formulated with a combination of CP 974P and HPMC K4M. The compacts were evaluated in vitro for 24 hr in pH 6.6 phosphate buffer using a standardized dissolution apparatus. The data were evaluated by a simple power equation (Mt/M infinity = Ktn); it was observed that all the compacts followed non-Fickian release kinetics. Some of the buccoadhesive compacts were evaluated in vivo in rabbits. The compacts gave controlled blood level profiles with a twofold to threefold increase in area-under-the-curve (AUC) values in comparison to oral administration of aqueous drug solution.

Adhesives↗
PubMed1999

Biopharmaceutical drug development: Filgrastim (r-metHuG-CSF) use in patients with HIV infection.

Hematopoietic growth factors are well known to increase neutrophil counts and support the administration of myelotoxic and myelosuppressive therapies, especially chemotherapies. Filgrastim (r-metHuG-CSF) has been used in the setting of HIV disease to treat neutropenia and HIV-associated neutrophil defects. This article reviews the biology, product characteristics, and preclinical and clinical development of Filgrastim. Emphasis is given on the use of Filgrastim in the setting of HIV infection and AIDS.

Acquired Immunodeficiency Syndrome↗