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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

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Published on: December 11, 2016

New drugs 07, part I.

Daniel A Hussar1

  • 1Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA, USA.

Nursing
|February 3, 2007
PubMed
Summary

This article reviews 13 new medications, including insulin analogues for diabetes, ranolazine for chronic angina, and conivaptan HCl for hyponatremia. It provides essential information for adult use, with warnings for pregnancy and breastfeeding.

Area of Science:

  • Pharmacology
  • Internal Medicine
  • Drug Development

Background:

  • Chronic angina and hyponatremia are significant health concerns.
  • Existing treatments for these conditions have limitations.
  • Advancements in pharmaceutical research have led to novel therapeutic agents.

Purpose of the Study:

  • To introduce and summarize key information on 13 newly approved drugs.
  • To highlight significant new treatments for chronic angina and hyponatremia.
  • To provide a concise overview of drug indications, safety, and usage.

Main Methods:

  • Review of newly approved drug information.
  • Summarization of clinical applications and pharmacological profiles.
  • Compilation of safety data, including precautions and contraindications.

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Main Results:

  • Introduction of insulin glulisine and insulin detemir, human insulin analogues.
  • Approval of ranolazine for chronic angina treatment.
  • Approval of conivaptan HCl for hyponatremia in specific patient populations.

Conclusions:

  • The article provides a valuable resource for healthcare professionals on new drug therapies.
  • New medications offer improved treatment options for cardiovascular and endocrine disorders.
  • Emphasis on consulting package inserts for comprehensive drug safety and interaction information is crucial.