Exit exams from a regulatory perspective

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In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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...
Drug Elimination: Overview01:18

Drug Elimination: Overview

Drug elimination involves many complex processes and does not necessarily differentiate between distribution and elimination. It is divided into two primary components: excretion and biotransformation.
Excretion refers to removing a drug from the body, either in its unchanged form or as its metabolites. Nonvolatile and polar drugs are primarily excreted through the kidneys, with other pathways including bile, sweat, saliva, and milk. Volatile drugs such as anesthetic gases are excreted via the...
Drug Excretion: Miscellaneous Routes01:10

Drug Excretion: Miscellaneous Routes

Drug excretion involves various organs, including the liver, intestines, skin, and eyes. In the case of drugs or toxins, they can be actively secreted into bile by transporters in the hepatocyte's canalicular membrane. These substances enter the GI tract during digestion and may be reabsorbed into the body from the intestine. This process, known as enterohepatic recycling, can significantly prolong the presence and effects of a substance in the body. To interrupt this cycle, specific substances...
Drug Elimination: The Concept of Clearance01:06

Drug Elimination: The Concept of Clearance

Drug elimination refers to removing drugs from the body, either through urine by the kidneys or through bile by the liver. Drug clearance is a pharmacokinetic parameter that measures the efficiency of drug removal from the bloodstream within a specific time frame. It is calculated as the rate at which a drug is eliminated from plasma divided by the plasma concentration of the drug.
Drug clearance is not limited to renal excretion but encompasses all organs involved in drug elimination,...
Regulation of Expression Occurs at Multiple Steps02:24

Regulation of Expression Occurs at Multiple Steps

Gene expression can be regulated at almost every step from gene to protein. Transcription is the step that is most commonly regulated. This involves the binding of proteins to short regulatory sequences on the DNA. This association can either promote or inhibit the transcription of a gene associated with the respective sequence.
Transcription results in the generation of precursor (pre-mRNA) that consists of both exons and introns, which needs further processing before being translated to a...