The basics of clinical pharmacology
Conrad Harris, Jane Richards in Prescribing in General Practice, 2018
Many doctors have only vague ideas of what clinical pharmacology is and only distant memories of what they were taught about it. Clinical pharmacology is best defined as the study of drugs and their effects in people and on society. It clearly has an educational role for health care professionals and roles in drug development and drug safety. It also is very practical, addressing the optimal use of drug therapy for patient benefit while minimizing adverse effects. Some doctors argue that one does not need to know any clinical pharmacology to use drugs perfectly adequately. While this may work where prescribing is purely a reflex action, doctors today need to understand the basics of clinical pharmacology to make best use of existing drugs, especially in patients with complex problems, and to evaluate the many new drugs which emerge every year.
A Futuristic View
Gary M. Matoren in The Clinical Research Process in the Pharmaceutical Industry, 2020
Clinical pharmacology in recent decades has had great difficulty in establishing its role in an acceptable and uncontroversial way in many medical institutions. Essentially this difficulty has stemmed from the confusion of clinical pharmacology and experimental therapeutics. Clinical pharmacology is the domain of the clinically orientated researcher whose role is to define the actions and side effects of drugs in physiologically normal humans and in appropriate models of disordered physiology which can be reversibly developed in normal humans. Experimental therapeutics must be seen to be the appropriate domain of the clinician, with research training dedicated to study the therapeutic efficacy of drugs in patients.
Drug Development and Clinical Pharmacology
Scott Patterson, Byron Jones in Bioequivalence and Statistics in Clinical Pharmacology, 2017
Clinical pharmacology is the study of drugs in humans [30]. It blends the science of laboratory assessment of chemicals with the clinical and medicinal art of their application. Many textbooks are devoted to the proper study of clinical pharmacology, and we shall dwell only on those aspects which will be important for the subsequent chapters of this book.
Pharmaceutical Formulation Methods for Improving Retinal Drug Delivery
Published in Seminars in Ophthalmology, 2019
Tomasz P. Stryjewski, James A. Stefater, Dean Eliott
A familiar memory for anyone having completed a clinical education in medicine is the long hours spent memorizing drugs, dosages, and mechanisms of action for treatment of various ailments. This typical curriculum of clinical pharmacology focuses primarily on the drug’s Active Pharmaceutical Ingredient (also referred to as the drug substance or simply the active ingredient). Less commonly taught is the basis for why various excipients, or inactive ingredients, are included in the final finished form of the drug (also known as the drug product), which allow the drug to act in the manner that is intended. The inclusion of these excipients, which can be included to facilitate manufacturing, improve shelf stability, create an easier delivery method (such as in the form of an oral liquid), or control the kinetics of the drug’s release, can be a “make or break” step in determining whether a drug will cross the chasm from interesting science to a feasible, routinely used clinical therapeutic. The procedure for optimizing the mixture of the drug substance with excipients is known as formulation. This paper reviews the formulation methods used in several commonly used retinal drug products.
Classes of drugs that target the cellular components of inflammation under clinical development for COPD
Published in Expert Review of Clinical Pharmacology, 2021
Maria Gabriella Matera, Luigino Calzetta, Rosa Annibale, Francesco Russo, Mario Cazzola
A single clinical, biological or physiological characteristic is not sufficient to define a phenotype but there is a need to integrate more characteristics. Therefore, integrating clinical features, biology, and therapeutics as proposed for asthma [135] is now a must to improve outcomes in COPD. The use of very large datasets from multiple platforms and machine learning approaches allows clustering patients defined by clinical and physiological characteristics, different pathobiological pathways, and impact of therapies on symptoms and manifestations as emerged from separate studies. This method is crucial to integrate all the contrasting information and could help to understand the reasons behind differences. The importance of such an approach also stems from the surprising recent evidence that often clinical trials, rather than preclinical and clinical pharmacology studies, have brought to light several clinically relevant issues.
Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives
Published in Current Medical Research and Opinion, 2022
Shereen Cox, Jan Helge Solbakk, Rosemarie D. L. C. Bernabe
The interviewees held positions of REC chair (4), members (12), secretary (1), advisor (1), and chair of an ethics appeals committee (1). The qualifications range from masters to Ph.D. degrees in philosophy, medicine, law, pharmacy, immunology, toxicology, microbiology, clinical pharmacology, and psychology. Three interviewees had formal qualifications in applied ethics at the Master’s level. The years of experience on their respective ethics review boards ranges from 5.5 to 30 years. The countries represented are listed in the table below as well as the responses to the questions regarding ethics training, organization of committees, main activities before and after approval of clinical trials, management of protocol violations, and impact of new EU Regulations.
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