Drug development
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Drug development involves preclinical and clinical phases. Preclinical development can take 1-5 years and involves in vitro and in vivo studies to determine pharmacological efficacy, safety, and first human dose. Clinical development has four phases. Phase I studies a drug's safety on 50-100 healthy volunteers. Phase II assesses efficacy on 100-400 patients. Phase III verifies efficacy and safety on 500-2000 patients across sites. Phase IV monitors safety post-marketing through physician reporting. The goal is to determine a drug's pharmacological properties, safety, and efficacy to support regulatory approval and post-market surveillance.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
How STIs Influence the Development of Pelvic Inflammatory Disease.pptx
STIs may cause PID. For the both disease, herbal medicine Fuyan Pill can be a solution.
ABDOMINAL TRAUMA in pediatrics part one.
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
A Classical Text Review on Basavarajeeyam
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
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REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
It includes regulation of combination products and medical devices. FDA and industry liaisons.
NVBDCP.pptx Nation vector borne disease control program
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
How STIs Influence the Development of Pelvic Inflammatory Disease.pptx
How STIs Influence the Development of Pelvic Inflammatory Disease.pptx
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
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Phone Us ❤8107221448❤ #ℂall #gIRLS In Dehradun By Dehradun @ℂall @Girls Hotel...
Tests for analysis of different pharmaceutical.pptx
Tests for analysis of different pharmaceutical.pptx
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
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Thyroid Gland- Gross Anatomy by Dr. Rabia Inam Gandapore.pptx
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
NVBDCP.pptx Nation vector borne disease control program
NVBDCP.pptx Nation vector borne disease control program
Drug development
- 1. Drug Development Medical Pharmacology Department Gehad Sayed
- 3. Drug development preclinical clinical In-vitro In-vivo Phase I Phase II Phase III Phase IV
- 4. Goal: 1. Determine pharmacological efficacy: a) ED50 b) Comparison with a standard drug. c) Mechanism of action. 2. Pharmacokinetic studies. 3. Safety evaluation(LD50). 4. Determine “first in human” dose. Preclinical Drug Development
- 6. Duration: 1-5 years. Examples: In Vitro: Isolated Rabbit’s intestine (jejunum). Isolated Toad’s heart In Vivo: Blood pressure recording in anaesthetized cat. Effect of drugs on Rabbit’s eye. Preclinical Drug Development
- 8. IRBs approve the clinical trial protocols -The type of people who may participate -The schedule of tests and procedures -The medications and dosages to be studied -The length of the study -The study's objectives, and other details IRBs make sure the study is acceptable that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm IND application
- 9. Phase I Study population: Healthy volunteers ( 50– 100 ). Purpose: 1. Drug safety ( the main goal). 2. Pharmacokinetic studies and drug interactions 3. Drug efficacy : dose escalation studies. Duration: 1 year. Clinical Drug Development
- 10. Phase II Study population: Some patients with the target disease ( 100– 400). Purpose: 1. Initial assessment of efficacy (proof-of-concept). 2. Further assessment of safety. Duration: 2 years Clinical Drug Development
- 11. Phase III Study population: large number of patients with the target disease ( 500– 2000) in multicenters Purpose: 1. Verifying efficacy. 2. Establishing safety. Duration: 3 years. Clinical Drug Development
- 12. NDA Submission NDA Approved 12 months NDA Review
- 15. Phase IV Study population: post marketing surveillance. Purpose: 1. Confirm the safety of the product in large patient populations. 2. Involve adverse event reporting by physicians. Clinical Drug Development
- 16. Summary
- 17. Recommended Reading ■ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm ■ http://www.medscape.com/viewarticle/405869_4 ■ https://en.wikipedia.org/wiki/Drug_development