Publications by authors named "Keith Gallicano"
Article Synopsis
- The Global Bioequivalence Harmonization Initiative (GBHI) was created to align regulatory standards for bioequivalence assessments globally, starting in 2015 through conferences organized by EUFEPS and AAPS.
- The 2nd GBHI conference in 2016 focused on key topics like prodrugs, scaling procedures, and excluding pharmacokinetic data from BE assessments.
- Discussions at the conference fostered a better understanding among pharmaceutical scientists and helped harmonize regulations related to the approval of multisource drug products.
Objectives: Extensive but fragmented data from existing studies were used to describe the drug-drug interaction between rifabutin and HIV PIs and predict doses achieving recommended therapeutic exposure for rifabutin in patients with HIV-associated TB, with concurrently administered PIs.
Methods: Individual-level data from 13 published studies were pooled and a population analysis approach was used to develop a pharmacokinetic model for rifabutin, its main active metabolite 25-O-desacetyl rifabutin (des-rifabutin) and drug-drug interaction with PIs in healthy volunteers and patients who had HIV and TB (TB/HIV).
Results: Key parameters of rifabutin affected by drug-drug interaction in TB/HIV were clearance to routes other than des-rifabutin (reduced by 76%-100%), formation of the metabolite (increased by 224% in patients), volume of distribution (increased by 606%) and distribution to the peripheral compartment (reduced by 47%).
Article Synopsis
- The study investigates how to measure the bioavailability of two different sodium ferric gluconate complex (SFGC) formulations, comparing a new method to a traditional noncompartmental approach, due to the unique pharmacokinetics of iron.
- Data from two open-label clinical studies were analyzed: Study 1 involved 240 subjects receiving a 125 mg dose, while Study 2 had 29 subjects receiving a 62.5 mg dose; both measured total iron and transferrin-bound iron over specified timeframes.
- Results indicated that while the new population pharmacokinetic model showed promising bioequivalence for the formulations, the traditional analysis in Study 2 didn’t meet bioequivalence criteria
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis.
View Article and Find Full Text PDFInteractions between natural health products (NHP) and prescription medications are of increasing concern. This paper aims to identify all clinical trials of NHP-drug interactions. To determine the prevalence and outcomes of clinical investigations of NHP-drug pharmacokinetic interactions, electronic databases were searched from inception through March 2004, as well as reference lists from published reports and experts in the field for unpublished studies.
View Article and Find Full Text PDFObjectives: To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir.
Methods: We conducted a three-period, randomized controlled trial with 16 healthy participants. We randomized participants to milk thistle or control.
Objective: The objective of this study was to explore the pharmacokinetics of nelfinavir and its active metabolite hydroxy-t-butylamidenelfinavir (M8) during pregnancy and post partum.
Methods: Eleven human immunodeficiency virus type 1-infected pregnant women receiving 1250 mg nelfinavir twice daily were enrolled. Pharmacokinetics of nelfinavir and M8 were assessed over a 12-hour period during pregnancy (median, 32 weeks' gestation; range, 31-36 weeks) and post partum (median, 8 weeks post partum; range, 6-15 weeks).
Objective: To determine the methodological quality of clinical trials that examined possible interactions of St John's wort with conventional drugs, and to examine the results of these trials.
Design: Systematic review.
Data Sources: Electronic databases from inception to April 2004, reference lists from published reports, and experts in the field.
Aims: To evaluate the effect of acute dosing of garlic supplements on the single-dose pharmacokinetics of ritonavir.
Methods: Ten healthy volunteers (five male, five female) were equally randomized in a crossover design to receive 400 mg of a single dose of ritonavir within 10 min after eating breakfast either alone or with 10 mg of Natural Source Odourless Garlic. They received a total of eight doses of garlic extract (2 x 5 mg capsules) taken twice daily for 4 days.
Herbal therapies are widely used, but there are few data on their interactions with conventional medications. This study evaluated the effect of garlic supplements on the pharmacokinetics of saquinavir. Ten healthy volunteers received 10 doses of saquinavir (Fortovase) at a dosage of 1200 mg 3 times daily with meals for 4 days on study days 1-4, 22-25, and 36-39, and they received a total of 41 doses of garlic caplets taken 2 times daily on study days 5-25.
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