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"Clinical pharmacology"
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Pathology and therapeutics for pharmacists : a basis for clinical pharmacy practice
Aims to show the rationale and role of drug therapy in the management of some common diseases through a consideration of the mechanisms of disease processes in relation to normal function.
Book
Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges
Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with poor water solubility or low permeability, techniques such as amorphous solid dispersion, liposomes, and complexations have been used to improve their oral bioavailability. Modified release (MR) formulations have been widely used to improve patient compliance, as well as to reduce side effects, especially for those drugs with short half-lives or narrow therapeutic windows. More than ten drugs using sterile long-acting release (LAR) formulations with clear clinical benefit have been successfully marketed. Furthermore, drug delivery systems have been used in delaying drug clearance processes. Additionally, modifying the in vivo drug distribution using targeted delivery systems has significantly improved oncology treatments. All the drug delivery approaches have their advantages and limitations. For both brand and generic drugs, the achievement of consistent quality and therapeutic performance using drug delivery systems can also pose serious challenges in developing a drug for the market, which requires close collaboration among industry, academia, and regulatory agencies. With the advent of personalized medicines, there will be great opportunities and challenges in utilizing drug delivery systems to provide better products and services for patients.
Journal Article
The final hurdle : single best answers in clinical pharmacology and therapeutics
This book focuses on reinforcing core concepts, improving exam technique and developing confidence in answering the style of questions used in the examinations.
Book
Clinical pharmacology—how it shapes the drug development journey
Every drug development is a complex and long journey. Clinical pharmacology is an essential discipline in modern drug development. With its applications, computational modelling, and simulation techniques, it can significantly contribute to the efficiency in drug development today. In this perspective, we highlight why pharmacokinetics and pharmacodynamics are important, what developers need to consider in their clinical development programme, how modelling influences the development process, and discuss recent trends such as artificial intelligence and machine learning that have the potential to reshape future drug development.
Journal Article
Advanced Clinical Pharmacy and Toxicology
From a practical point of view, hospital pharmacy, clinical pharmacy, community pharmacy, chain pharmacy, forensic pharmacy, etc., are flourishing day by day. The book titled \"Advanced Clinical Pharmacy and Toxicology\" is organized with advanced information about Clinical Pharmacy and its applications in modern healthcare, drug dispensing strategy, manifestation, pathophysiology, and diagnosis of diseases, biopharmaceutical and pharmacokinetic aspects of drugs and drug-like substances, drug interactions with other drugs, chemicals, foods, and pathological states along with their pathophysiological impacts, and adverse drug interventions. In the Toxicology part, toxicological manifestations of drugs, chemicals, and biologicals, drug abuse and its impacts, toxicological studies and their implementations in analytical studies and healthcare, toxin biotransformation and overall impacts, and molecular interactions and pathophysiological contributions of toxins have been summarized. Thus, the contents of this book will cover Clinical Pharmacy and Toxicology in Pharmacy, Medical, Biomedical, and other relevant subjects in our educational areas. It contains a detailed discussion of modern clinical pharmacy and toxicology, which will play a special role in developing experienced hospital and clinical pharmacists.
eBook
Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective
Immunogenicity assessment is important for biological products due to potential impacts of immunogenicity on safety and efficacy. We reviewed the prescribing information and the FDA’s clinical pharmacology review of 121 approved biological products for evaluating and reporting of immunogenicity data. Of the 121 products, 89% (n = 108) reported the incidence of immunogenicity and 49% (n = 59) reported immunogenicity impact on efficacy. However, only 26% (n = 31) reported whether the immunogenicity affected pharmacokinetics. A subset of 16 products reported effects of anti-drug antibodies (ADA) on both systemic clearance and efficacy; 8 of 16 products had increased systemic clearance coinciding with reduced efficacy, and 6 of 16 products had no changes in either clearance or efficacy. Factors contributing to infrequent reporting of the ADA effect on exposure and methods for determining the effect of ADA on exposure are summarized. Measuring ADA and drug concentrations concurrently over time enables the evaluation of ADA impact on pharmacokinetics. Within-subject comparison of concentration data (before vs. after ADA formation) is a useful alternative to between-subject (ADA+ vs. ADA−) comparison when sample size is limited or when the majority of subjects developed ADA. The biological complexity of immune responses presents challenges to quantifying the ADA impact on pharmacokinetics using model-based methods. Our findings support that pharmacokinetic exposure is more sensitive than efficacy endpoints for evaluating ADA effects. A decrease in drug concentration due to formation of ADA during treatment can serve as an early indicator for potential reduced efficacy occurring at a later time.
Journal Article
Adverse drug reactions
Adverse drug reactions (ADRs) remain a challenge in modern healthcare, particularly given the increasing complexity of therapeutics, an ageing population and rising multimorbidity. This article summarises some of the key facts about ADRs and explores aspects relating to their prevention, diagnosis, reporting and management in current clinical practice.
Journal Article
WHO guide to good prescribing is 25 years old: quo vadis?
IntroductionTwenty-five years ago, the World Health Organization (WHO) published the Guide to Good Prescribing (GGP), followed by the accompanying Teacher’s Guide to Good Prescribing (TGGP). The GGP is based on a normative 6-step model for therapeutic reasoning and prescribing, and provides a six-step guide for students to the process of rational prescribing.MethodWe reviewed the need to update both WHO publications by evaluating their use and impact, including new (theoretical) insights and demands. Based on information from literature, Internet, and other (personal) sources, we draw the following conclusions.Results1. An update of the GGP and TGGP, both in terms of content and form, is necessary because of the current need for these tools (irrational medicine use and unavailability of medicines), the lack of similar documents, and the lack of connection with recent developments, such as Internet and modern education; 2. The basic (6-step) model of the GGP is effective in terms of rational prescribing in the undergraduate situation and is still consistent with current theories about (context) learning, clinical decision-making, and clinical practice; 3. The dissemination and introduction of the GGP and TGGP in education has been successful so far, but is still not optimal because of lack of support and cooperation.ConclusionsOn the basis of the evaluation results, a plan for the revision of the GGP and TGGP is presented.
Journal Article
Switching from a traditional undergraduate programme in (clinical) pharmacology and therapeutics to a problem-based learning programme
PurposeThe pharmacology and clinical pharmacology and therapeutics (CPT) education during the undergraduate medical curriculum of NOVA Medical School, Lisbon, Portugal, was changed from a traditional programme (i.e. discipline-based, lectures) to a problem-based learning (PBL) programme (i.e. integrated, case-based discussions) without an increase in teaching hours. The aim of this study was to investigate whether this change improved the prescribing competencies of final-year medical students.MethodsFinal-year students from both programmes (2015 and 2019) were invited to complete a validated prescribing assessment and questionnaire. The assessment comprised 24 multiple-choice questions in three subdomains (working mechanism, side-effects and interactions/contraindications), and five clinical case scenarios of common diseases. The questionnaire focused on self-reported prescribing confidence, preparedness for future prescribing task and education received.ResultsIn total, 36 (22%) final-year medical students from the traditional programme and 54 (23%) from the PBL programme participated. Overall, students in the PBL programme had significantly higher knowledge scores than students in the traditional programme (76% (SD 9) vs 67% (SD 15); p = 0.002). Additionally, students in the PBL programme made significantly fewer inappropriate therapy choices (p = 0.023) and fewer erroneous prescriptions than did students in the traditional programme (p = 0.27). Students in the PBL programme felt more confident in prescribing, felt better prepared for prescribing as junior doctor and completed more drug prescriptions during their medical training.ConclusionChanging from a traditional programme to an integrated PBL programme in pharmacology and CPT during the undergraduate medical curriculum may improve the prescribing competencies of final-year students.
Journal Article