15. (Drug Development) What is the major difference in regulatory requirements between the approval of a new API dosage form (NDA) and a generic dosage form (ANDA)?
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A: Answer :- The FDA approval process for assessing the safety and efficacy of a newly developed drug…
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A: ♦ANSWER♦19 •Given value, •Ordered dose = 750 mg •Avaiable dose = 500 mg
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- 2.Pharmacodynamics: Drug Receptors subserve two essential functions: (1) recognition of the specific ligand molecule (2) transduction of the signal into a response. Accordingly, the receptor molecule has a ligand binding domain (spatially and energetically suitable for binding the specific ligand) and an effector domain which undergoes a functional conformational change. These domains have now actually been identified in some receptors. The perturbation in the receptor molecule is variously translated into the response. Considerable progress has been made in the understanding of transducer mechanisms which in most instances have been found to be highly complex multistep processes that provide for amplification and integration of concurrently received extra- and intracellular signals at each step. Because only a handful of transducer pathways are shared by a large number of receptors, the cell is able to generate an integrated response reflecting the sum total of diverse signal input.…What properties of drug are relevant for developing modified release drug delivery formulation. Please briefly explain this at your own words.Please give me a discussion/explanation of ( TARGET SELECTION ) part in drug discovery and development.
- (c) Molnupiravir has not been approved but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate COVID-19 infection. Briefly explain this decision made by FDA based on the knowledge of clinical trials. (d) Both drugs are not allowed to be prescribed to person under 18 years old due to insufficient clinical data. Why is it necessary to separately conduct clinical trials for a younger age group?BiDil® is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status Question: The results of BiDil® clinical trials were compelling…Expound on the results. Question : What role did FDA’s approval resulted in BiDil® being a great example of pharmacogenomics/pharmacogenetics in the U.S.?How we can establish or improve Structure activity relationship(SAR) for the development of H1-Antihistamine drug?
- Briefly elaborate How preformulation studies help to find the drug performance and the development of a dosage form-Briefly explain this with different drug properties and example? Please answer at your own easy words.Describe the significance of the use of pharmacokinetic parameters in case to calculate appropriate drug dosing regimens.What are the potential implications of genetic variations in drug-metabolizing enzymes on individual response and therapeutic outcomes in clinical pharmacology?
- In a double blind clinical trial for a drug neither the subjects nor the researcher knows who is in the conrol group or the experimantal group both the experimental and the control group subjects get the drug that is under trial neither the control group nor the experimental group receive the placebo both the groups get placebo and only the researchers are aware of this fact, while both the groups are blinded of this fact both the experimental and control group subjects get placebo and the drug during any part of the study and are not aware of this double testUsing the coding techniques described in this chapter, carefully read through the case study and determine the most accurate CPT code(s) and HCPCS code(s) and modifier(s), if appropriate. Oscar Pettaway brought his unconscious 3-year-old daughter, Belinda, into the emergency department after finding her on the floor of the bathroom. An empty bottle of his wife's thyroid medication, Synthroid, was lying by her side. Oscar told the physician on call, Dr. Rubinstein, that his wife had just refilled the prescription. Dr. Rubinstein immediately evaluated Belinda's condition and, after obtaining permission from Oscar, ordered a gastric aspiration and lavage be done immediately, due to the poisoning. Be sure to list the codes, one code per box, in the correct order, from top to bottom. Capitalization, punctuation, and spacing can impact whether or not your answer is correct. Follow coding best practices. Determine the most accurate procedure codes, using the CPT code set and modifier(s), if…18. A study is conducted to assess the efficacy of gabapentin for the treatment of epilepsy. The authors undertook a search of both the published and unpublished literature After independent assessment of two authors, 33 of 107 papers meet inclusion criteria for the study. The authors describe the data from these studies but are unable to calculate a summary statistic because of the significant heterogeneity of the studies. Which of the following best describes this study design? OA) Case-control study OB) Meta-analysis C) Narrative review OD) Randomized controlled trial OE) Systematic review