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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Lipinski's rule of five, also known as Pfizer's rule of five or simply the rule of five (RO5), is a rule of thumb to evaluate druglikeness or determine if a chemical compound with a certain pharmacological or biological activity has chemical properties and physical properties that would likely make it an orally active drug in humans.
If the template has a separate documentation page (usually called "Template:template name/doc"), add [[Category:Drug templates]] to the <includeonly> section at the bottom of that page.
[[Category:Drug templates by structure]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Drug templates by structure]]</noinclude> to the end of the template code, making sure it starts on the same line as the code's last character.
Template:Drugs for functional gastrointestinal disorders; Template:Drugs for obstructive airway diseases; Template:Drugs for peptic ulcer and GORD; Template:Drugs for treatment of bone diseases; Template:Drugs for treatment of hyperkalemia and hyperphosphatemia; Template:Drugs used in benign prostatic hypertrophy
If the template has a separate documentation page (usually called "Template:template name/doc"), add [[Category:Drug templates by receptor, channel, or pump]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Drug templates by receptor, channel, or pump]]</noinclude>