Pre &; post marketting survellance
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Pre-marketing clinical trials evaluate drug safety and efficacy in a controlled environment with a small number of carefully selected patients, whereas post-marketing monitoring observes drugs' long-term effectiveness and safety in a larger and more diverse population after commercialization to identify additional adverse effects. Pre-marketing trials benefit from strict protocols while post-marketing monitoring provides insights into real-world use. Both stages are important to fully understand a drug's risks and benefits.
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Clinical trial
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Phase 1 trials are conducted to determine the maximum tolerated dose (MTD) and safety profile of a new drug in a small number of healthy human volunteers. Phase 2 trials explore efficacy and further evaluate safety in a targeted patient population. Phase 3 trials confirm efficacy and monitor long-term safety in a large patient population, often through comparison to standard treatment. Phase 4 trials study effectiveness and safety during widespread use in the general patient population after marketing approval.
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This document provides information about lipids and fatty acids. It begins by defining lipids and listing their main functions in the body. It then classifies lipids as simple, complex, or derived, and as saponifiable or non-saponifiable. The document further describes the chemistry and classification of fatty acids, including saturated, unsaturated, monounsaturated, and polyunsaturated fatty acids. It also discusses the nomenclature and isomerism of fatty acids. The key reactions of triacylglycerols are described.
Hormones
Hormones are chemical messengers that are secreted into the blood by endocrine glands and have profound effects on metabolic processes and cellular communication. They can be classified based on their chemical composition, location of receptors, or solubility. The major classes of hormones include steroids such as sex and adrenal hormones, peptides/proteins such as insulin and growth hormone, and amines such as epinephrine. Steroid hormones are derived from cholesterol and include estrogens, androgens, progesterone, corticosteroids, and aldosterone. Peptide hormones include insulin, glucagon, and somatostatin which are secreted by the pancreas, as well as hormones from the pituitary, parathyroid,
Enzymes
This document discusses enzymes and their properties. It begins by defining enzymes as globular proteins that act as biological catalysts to facilitate chemical reactions in living organisms. It then describes general enzyme characteristics such as their catalytic power, specificity, and ability to have their activity regulated. The document discusses how enzymes are named using systematic and common nomenclature systems. It also covers enzyme classification, cofactors/coenzymes, mechanisms of action, factors that influence activity, and kinetic models like Michaelis-Menten. Overall, the document provides a comprehensive overview of the key concepts regarding enzymes.
Urea cycle
1. The urea cycle is a series of enzymatic reactions that occurs primarily in the liver to convert toxic ammonia produced from amino acid catabolism into urea for excretion.
2. The cycle involves five principal reactions: carbamoyl phosphate synthesis, citrulline synthesis, argininosuccinate synthesis, argininosuccinate cleavage, and arginine cleavage into ornithine and urea.
3. The urea cycle serves two major biological roles - detoxification of ammonia into urea and biosynthesis of the amino acid arginine from ornithine in tissues like liver, kidney, and intestine.
Lipid catabolism (fatty acid oxidation)
1) Fatty acids undergo beta-oxidation in the mitochondria to break them down into acetyl-CoA units, releasing energy.
2) Beta-oxidation involves a four-step cycle that removes two-carbon acetyl-CoA units from the fatty acid.
3) The complete breakdown of a fatty acid like stearic acid yields 9 acetyl-CoA molecules which enter the citric acid cycle, producing a total of 146 ATP molecules through electron transport chain reactions.
Glycogenolysis
Glycogen metabolism involves the breakdown of glycogen to glucose-6-phosphate through glycogenolysis. Glycogenolysis occurs in three steps: 1) glycogen phosphorylase cleaves glucose from glycogen, 2) transferase and alpha-1,6-glucosidase remodel glycogen to allow further degradation, and 3) phosphoglucomutase converts glucose-1-phosphate to glucose-6-phosphate. In liver, glucose-6-phosphatase converts glucose-6-phosphate to glucose for blood glucose regulation. In muscle, glucose-6-phosphate enters glycolysis for rapid energy production.
Glycogen metabolism
This document discusses glycogen metabolism. It notes that glycogen is a readily available form of glucose storage found primarily in the liver and muscles. Glycogen synthesis, or glycogenesis, occurs in the fed state in these tissues and involves three steps - isomerization of glucose-6-phosphate to glucose-1-phosphate, activation of glucose-1-phosphate to UDP-glucose, and linkage of UDP-glucose to a glycogen chain catalyzed by glycogen synthase. Glycogen branching is accomplished by the enzyme amylo-(1,4-1,6)-trans-glycosylase which transfers glycogen segments to form branches. The synthesis and breakdown of glycogen in the liver and muscles
Gluconeogenesis
Gluconeogenesis is the metabolic pathway by which glucose is synthesized from non-carbohydrate materials to maintain blood glucose levels during periods without food intake. It takes place primarily in the liver and involves bypasses of three irreversible steps in glycolysis. Precursors like lactate, glycerol, and certain amino acids are converted to pyruvate and then glucose. The pathway requires energy in the form of 6 ATP molecules to synthesize one glucose molecule from two pyruvate. Gluconeogenesis is important for supplying glucose to tissues like the brain and helps maintain normal blood sugar through processes like the Cori cycle.
Citric acid cycle (2)
The citric acid cycle is the principal process for generating reduced coenzymes NADH and FADH2, which are necessary for ATP synthesis. It takes place in the mitochondrial matrix and involves eight steps catalyzed by different enzymes. Acetyl-CoA enters the cycle and is oxidized, producing carbon dioxide and the reduced coenzymes that fuel ATP production. Regulation occurs at three steps to precisely adjust the cycle's rate according to cellular energy needs. Overall, 12 ATP molecules are generated for each acetyl-CoA molecule that completes the citric acid cycle.
Cholesterol biosynthesis
This document provides an overview of cholesterol biosynthesis, which occurs in most cells but primarily in the liver and intestine. There are 5 stages: 1) acetyl-CoA is converted to mevalonate, 2) mevalonate is converted to activated isoprene units, 3) six isoprene units condense to form squalene, 4) squalene is cyclized to lanosterol, and 5) lanosterol is converted to cholesterol over 20 steps. HMG-CoA reductase, which converts HMG-CoA to mevalonate, is the rate-limiting step and is regulated by feedback from cholesterol and bile acids as well as hormones like insulin, glucagon
Carbohydrate
This document provides information on carbohydrates and monosaccharides. It defines carbohydrates and explains their four main functions in living organisms. It then classifies carbohydrates into monosaccharides, disaccharides, oligosaccharides, and polysaccharides. The document focuses on monosaccharides, describing their structures, classifications, stereochemistry including D and L isomers, anomers, mutarotation, and important naturally occurring monosaccharides like glucose, fructose, and ribose. It also outlines important reactions of monosaccharides such as oxidation, reduction, glycoside formation, and phosphate ester formation.
Carb lec 2 & 3 slides
This document provides an overview of carbohydrate biochemistry. It defines carbohydrates as polyhydroxy aldehydes or ketones and classifies them based on molecular size into monosaccharides, disaccharides, oligosaccharides, and polysaccharides. Monosaccharides are further classified as aldoses or ketoses depending on whether they have an aldehyde or ketone functional group. The document discusses carbohydrate stereochemistry, including D and L isomers, enantiomers, and diastereomers. It also covers optical activity and how carbohydrate enantiomers can rotate plane-polarized light. Epimers are described as diastereomers that differ at only one chiral carbon.
Transcription translation
This document summarizes the processes of transcription and translation. It explains that during transcription, RNA polymerase makes an mRNA copy of a gene from DNA. The mRNA then moves to the ribosomes in the rough ER for translation. During translation, ribosomes and tRNA molecules work together to translate the mRNA into a polypeptide chain according to the mRNA's codon sequence. The process continues until a stop codon is reached, and the polypeptide chain is released. Mutations can occur during these processes, potentially resulting in non-functional or disease-causing proteins. Examples of different mutation types and their effects are provided.
Nucleic acids
Nucleic acids are macromolecules made of nucleotides that contain three components: a 5-carbon sugar, phosphate group, and nitrogenous base. DNA and RNA are the two main types of nucleic acids. DNA contains the sugar deoxyribose and has a double helix structure, while RNA contains the sugar ribose and is single-stranded. Both are composed of nucleotides joined by phosphodiester bonds and function to carry genetic information for protein synthesis. Their primary differences are that DNA contains the base thymine while RNA contains uracil, and RNA is found in the cytoplasm while DNA remains in the nucleus.
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- 2. Pre-marketing are studies conducted to evaluate first, the safety and second, the efficacy of the new compound in humans.
- 3. Post-marketing monitoring includes the identification and monitoring of new additional adverse drug events from doctors or other health professionals. Unlike previous stages, these will be observational studies where the long-term effectiveness will be evaluated; these are conducted right after the commercialization of the drug to the “real world”.
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