The Symposium brought together more than 260 attendees and included representatives from academe, industry, health care professionals, consumer groups and patient advocacy organizations from across Canada. Mr. Neil Yeates, the Assistant Deputy Minister of the Health Products and Food Branch and Mr. Omer Boudreau, Director General of the Therapeutic Products Directorate of Health Canada gave the...

The use of natural health products (NHPs) within the HIV community is high. Several NHPs have demonstrated interactions with HIV medications that could contribute to drug failure. We aimed to conduct a systematic review of clinical trials examining NHP-HIV drug interactions and their methodological characteristics. We searched electronic databases and unpublished resources independently, in dup...

OBJECTIVES This study sought to assess the value of the Health Level 7/U.S. Food and Drug Administration Structured Product Labeling (SPL) drug knowledge representation standard and its associated terminology sources for drug-intolerance (allergy) decision support in computerized provider order entry (CPOE) systems. DESIGN The Regenstrief Institute CPOE drug-intolerance issue detection system...

candesartan cilexetil (cc) is a newer class of angiotensin ii receptor antagonist used for the treatment of hypertension. the solubility of the cc is very poor and its oral bioavailability is only 15%. the controlled-release polar lipid microparticles of cc (formulations f1, f2, f3 and f4) were prepared using variable erodible lipophilic excipients like hydrogenated castor oil, stearic acid, ce...

Introduction Dissolution is a characterization test commonly used by the pharmaceutical industry to guide formulation design and control product quality. Often, it is a required performance test for solid dosage forms,transdermal patches,and suspensions. It is also the only test that measures the rate of in vitro drug release as a function of time, which can reflect either reproducibility of th...

1 These ingredients are nonmonograph except when used to prepare acidulated phosphate fluoride treatment rinses identified in § 355.10(a)(3) of this chapter. for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug prod...

The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD) and describe how it can be help to ensure pharmaceutical quality. Quality by design is an essential part of the modern approach to pharmaceutical quality. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical proces...

Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed. Modeling and simulation methods are now more commonly used in drug product development and regulatory drug review. These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalence metrics for m...

This workshop report summarizes the proceedings of Day 1 a three-day on “Current State and Future Expectations Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes Controls”. Physiologically based biopharmaceutics models (PBBM) are tools which enable drug product quality attributes be linked in vivo performance. These rely key inputs order provide reliabl...