Pharmacology open access resources
The site is for any student or practitioner requiring Clinical Pharmacology knowledge, e.g. undergraduate and post-graduate students in medicine, pharmacy and pharmacology.
The site has been designed to increase understanding of important and sometimes difficult concepts and principles in Clinical Pharmacology. It is not intended to be comprehensive for all aspects of Clinical Pharmacology teaching.
A basic understanding of physiology and pharmacology is assumed.
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
Approved Drug Products with Therapeutic Equivalence Evaluations
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
The “Purple Book” originally was available as two separate lists of FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) and FDA-licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER).
The FDA has transitioned the Purple Book to a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
Currently, the searchable database contains information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.
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⚠ This website provides general information and discussion about medications, health, and related subjects. The words and other content provided in this website, and in any linked materials, are not intended and should not be construed as medical advice. If the reader or any other person has a medical concern, he or she should consult with an appropriately-licensed physician or other legally accredited health care worker in the country that resides or is visiting.
Please do not delay your medical concerns and potential health emergencies by searching information in this website, instead look out for medical opinion in the services that exist with that specific purpose and work under the respective local health-care regulations.
The views expressed on this blog and website have no relation to those of any academic, hospital, practice or other institution with which the authors are affiliated.
For other instances, the authors of this website do not have any conflict of interest with any institution or pharmaceutical company in particular, and do not receive any compensation about any licenced drug mentioned in the website. In the same matter, the website is not intended to recommend any specific patented medication.