Drug Development Process Overview

Pre-clinical and clinical.

Assessing safety, toxicity, pharmacokinetics, and metabolism of new chemical entities.

NCEs are compounds with promising activity against a biological target important in disease.

<p>Chemistry, Manufacturing, and Control.</p> Signup and view all the answers

<p>It is legally required to determine the drug's effects on critical organs before human trials.</p> Signup and view all the answers

<p>Using in vitro methods with isolated cells.</p> Signup and view all the answers

<p>Chemical makeup, stability, and solubility.</p> Signup and view all the answers

<p>It allows for the initiation of clinical trials in humans.</p> Signup and view all the answers

<p>To test the efficacy and safety of a new drug or medical device on animal subjects before human testing.</p> Signup and view all the answers

<p>It assesses a compound's affinity for its molecular target to minimize unwanted side effects.</p> Signup and view all the answers

<p>They measure the dissociation constant of a test compound to assess its affinity for a specific receptor.</p> Signup and view all the answers

<p>It determines the pharmacodynamic effects of a new compound both in vitro and in vivo.</p> Signup and view all the answers

<p>In vitro models (cell lines or isolated tissues) and in vivo models (normal animals or disease models).</p> Signup and view all the answers

<p>To ensure that the effects observed in molecular tests match outcomes in tissues and whole organisms.</p> Signup and view all the answers

<p>It helps relate the pharmacokinetic properties of the drug to its therapeutic effectiveness over time.</p> Signup and view all the answers

<p>It aims to prevent the compound from causing unwanted side effects due to binding to unrelated molecular targets.</p> Signup and view all the answers

<p>The drug may lose its effectiveness or reveal previously unseen effects, and there might be rebound effects upon cessation.</p> Signup and view all the answers

<p>In vitro profiling allows for accurate measurement of concentration-effect relationships using isolated tissues.</p> Signup and view all the answers

<p>In vitro studies typically use tissues from small laboratory animals and preparations rarely survive beyond a day, limiting experimental time.</p> Signup and view all the answers

<p>In vivo profiling involves testing in normal animal models within a living organism, allowing for long-term effects to be evaluated.</p> Signup and view all the answers

<p>Species differences can affect pharmacological specificity, meaning the same target may respond differently across species.</p> Signup and view all the answers

<p>Animal models help determine whether physiological effects lead to therapeutic benefits, bridging the gap between preclinical and clinical research.</p> Signup and view all the answers

<p>These models aim to mimic specific aspects of a clinical disorder to study the immediate drug effects.</p> Signup and view all the answers

<p>Animal models of disease can be classified into acute, chronic, and genetic models.</p> Signup and view all the answers

<p>Supplementary tests are additional evaluations that assess potential impacts of a drug on non-vital organ systems or specific safety concerns related to the drug's use.</p> Signup and view all the answers

<p>Safety pharmacology studies are not required for locally applied agents, when the pharmacology is well known, or for new derivatives with similar pharmacokinetics and pharmacodynamics.</p> Signup and view all the answers

<p>The need for supplementary tests depends on the therapeutic area, expected drug exposure, and regulatory authority requirements for specific drug classes.</p> Signup and view all the answers

<p>Common physiological tests for renal function include urine volume, osmolality, pH, and the presence of proteinuria.</p> Signup and view all the answers

<p>The evaluation of ventricular contractility primarily gauges the heart's pumping efficiency and overall cardiac function.</p> Signup and view all the answers

<p>Acute toxicity studies are important because they help assess the potential harmful effects of a drug in at least two species before human testing.</p> Signup and view all the answers

<p>Parameters evaluated include gastric secretion, gastric pH, intestinal motility, and gastrointestinal transit time.</p> Signup and view all the answers

<p>Supplementary tests provide more detailed mechanistic insights into the safety signals observed in the core battery of tests.</p> Signup and view all the answers

<p>The 4th revision allowed for placebo-controlled trials only in cases where no proven diagnostic or therapeutic method existed.</p> Signup and view all the answers

<p>The 5th revision made no references to research that had no potential benefit to participants.</p> Signup and view all the answers

<p>CIOMS stated that ethical standards in developing countries should be no less exacting than those adopted in the country initiating research.</p> Signup and view all the answers

<p>The ethical strength of the Declaration of Helsinki (DoH) was perceived to be weakened following the 6th revision.</p> Signup and view all the answers

<p>The 7th revision introduced provisions for compensation and treatment for those harmed in research.</p> Signup and view all the answers

<p>The FDA ignored the 4th revision and continued to refer to the 1989 version, while the EU cited the 4th revision in its clinical trial directive.</p> Signup and view all the answers

<p>The 3rd revision included guidelines on obtaining informed consent from minors for participation in research.</p> Signup and view all the answers

<p>The debates led to an extensive revision of the structure of the document, enhancing clarity and ethical standards.</p> Signup and view all the answers

<p>Placebos can be used when no proven intervention exists or when scientifically sound reasons justify their use without risking serious harm.</p> Signup and view all the answers

<p>Patients must be informed about the study's outcome and should have access to any beneficial interventions identified.</p> Signup and view all the answers

<p>Ethical concerns include the risk of inadequate standard care and the potential exploitation of vulnerable populations.</p> Signup and view all the answers

<p>The DoH provides ethical guidance to physicians but lacks legal authority, relying on moral obligation rather than legal enforcement.</p> Signup and view all the answers

<p>The DoH carries significant moral weight similar to the Hippocratic oath, guiding ethical research practices.</p> Signup and view all the answers

<p>The WMA encourages all participants in medical research involving human subjects to adopt the principles of the DoH.</p> Signup and view all the answers

<p>Financial incentives for pharmaceutical companies may lead to conflicts of interest and influence the conduct of clinical trials.</p> Signup and view all the answers

<p>Physicians should consider the ethical, legal, and regulatory norms specific to their countries in addition to applicable international standards.</p> Signup and view all the answers