DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: Preclinical Considerations for Cell and Gene Therapy Products
Patrick Au, Ph.D., (CBER)
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: Preclinical Considerations for Cell and Gene Therapy Products
Patrick Au, Ph.D., (CBER)
Do you know that is the difference between a healthcare sector and a pharma sector?
Don't worry. We are there to guide you!
Simply refer these 12 slides and understand the concept.
We focus on breaking down complex business processes into easy steps so that everyone can understand.
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An educational initiative by Spine Software Systems, the software backbone of Pharma sector.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Information about steps in pharmaceutical research via stages of drug development.
DISCOVERY
PRODUCT CHARACTERISATION
FORMULATION,DELIVERY,PACKING
DEVELOPMENT
PRECLINICAL TOXICOLOGYN TESTING & IND
BIOANALYTICAL TESTING
CLINICAL TRIALS
MAYBE WE ALL DON'T EVEN KNOW WHAT "CLINICAL TRIAL" ACTUALLY MEANS...
I THINK THIS SLIDES WILL HELP YOU TO KNOW...
PLEASE LIKE AND FOLLOW IF OUR WORK HAVE ANSWERED YOUR QUESTIONS...
THANK YOU;)
Typically, researchers discover new drugs through: New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. Many tests of molecular compounds to find possible beneficial effects against any of a large number of diseases.
Employment PracticesRegulation and Multinational CorporationsRoopaTemkar
Employment PracticesRegulation and Multinational Corporations
Strategic decision making within MNCs constrained or determined by the implementation of laws and codes of practice and by pressure from political actors. Managers in MNCs have to make choices that are shaped by gvmt. intervention and the local economy.
Enriching engagement with ethical review processesstrikingabalance
New ethics review processes at the University of Bath. Presented at the 8th World Conference on Research Integrity by Filipa Vance, Head of Research Governance and Compliance at the University of Bath. June 2024, Athens
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
Org Design is a core skill to be mastered by management for any successful org change.
Org Topologies™ in its essence is a two-dimensional space with 16 distinctive boxes - atomic organizational archetypes. That space helps you to plot your current operating model by positioning individuals, departments, and teams on the map. This will give a profound understanding of the performance of your value-creating organizational ecosystem.
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Public Speaking Tips to Help You Be A Strong Leader.pdfPinta Partners
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Integrity in leadership builds trust by ensuring consistency between words an...Ram V Chary
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
Comparing Stability and Sustainability in Agile SystemsRob Healy
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Case Analysis - The Sky is the Limit | Principles of Management
Pre-Clinical and Clinical Trials- Its design and Conduct, Risk Analysis, Quality assurance and Quality Control in a Drug Development
1. Pre-Clinical and Clinical Trials- Its design
and Conduct, Risk Analysis, Quality
assurance and Quality Control in a Drug
Development
2. • In drug development, pre-clinical development, also
named preclinical studies and nonclinical studies, is a
stage of research that begins before clinical trials (testing in
humans) can begin, and during which important feasibility,
iterative testing and drug safety data is collected.
• The main goals of pre-clinical studies are to determine the
safe dose and start to assess product’s safety profile.
Products may include new or iterated or like-kind medical
devices, drugs, gene therapy solutions, etc.
3. • Pre-Clinical Trials and Clinical Trials are the processes by which
scientists test drugs and devices to see if they are SAFE and
EFFECTIVE.
4. What is a Preclinical Trial?
• Preclinical trial - a laboratory test of a new drug or a
new medical device, usually done on animal subjects,
to see if the hoped-for treatment really works and if it is
safe to test on humans.
5. There are several steps involved with doing a Pre-
Clinical Trial:
File for approval as an Investigational New Drug
(IND)5
4
3
2
1
Establish Effective and Toxic Doses
Screen the Drug in the Assay
Develop a Bioassay
Indentify a Drug Target
6.
7. • Clinical trials are experiments done in clinical research.
• Clinical trials are experiments done in clinical research. A critical
part in the process of bringing new therapies to patients is clinical
development, the study of potential new therapies in humans.
• It typically takes 12 years from the moment of discovery in the lab
for a potential new therapy to gain approval for use and reach
patients. Clinical development is the most time intensive and
expensive part of this research and development
• There are 3 phases of clinical trials: Phase I, Phase II, and Phase III
8. Phase I Clinical Development (Safety and Exposure)
• After the drug pass its Pre-Clinical Trial Tests, it begins a Phase I
clinical trial.
• Phase I studies are used to evaluate exposure and tolerance,
typically in healthy volunteers.
• These studies may include initial single-dose studies, single dose
escalation studies, and short-term repeated-dose studies.
• An attempt is made to establish the dose range tolerated by
volunteers for single and for multiple doses
• Phase 1 trials usually focus on ensuring the therapy is safe to use
in people, rather than how effective it may be as a treatment for a
given disease.
9. Phase II Clinical Development (Safety and
Efficacy)
• Phase II clinical studies are small-scale trials to
evaluate a drug’s efficacy and side-effect profile.
• These studies are usually conducted in patients –
typically selected because they could benefit from
the new drug.
• They may vary in size, but are often from 100 to 250
patients.
• Additional safety and clinical pharmacology studies
are also included in this category
10. Phase III Clinical Development (Safety and confirmation of Efficacy)
• Phase III studies are larger scale clinical trials for safety and efficacy in a significant
number of patients.
• Phase III studies are in progress, preparations are made for submitting the Biologics
License Application (BLA) or a New Drug Application (NDA) for registration.
• BLAs are currently reviewed by the FDA’s Centre for Biologics Evaluation and
Research (CBER); NDAs are reviewed by the Centre for Drug Evaluation and
Research (CDER).
• Nonclinical activities to define safety continue throughout the Clinical Development
phase of drug development.
11. • These nonclinical activities may include ongoing ADME studies to define
metabolic pathways, potential drug-drug interactions and distribution, and
long-term safety studies designed to define the reproductive and carcinogenic
risk to human subjects.
• These studies are timed to coincide with the various phases of Clinical
Development and to provide safety information to support those trials.
• Nonclinical activities during the Clinical Development phase may also include
in vivo exposure studies in animal models to evaluate the pharmacokinetic
behaviour or determine the relative bioavailability of various drug
formulations.
• Drug formulations are often refined continuously throughout the Clinical
Development phase, culminating in a final dosage form that can be used in
definitive clinical trials and allow registration of the NCE as new drug.
12.
13. • Each project is unique, some degree of uncertainty always exists. As
uncertainty is a characteristic of projects is a risk.
• Risks always will be an essential part of project-oriented working.
• In effect, no one can avoid project risks.
• There are two categories under the heading impact of the risk: business
risks and insurable risks. Business risks are uncertain values having both
opportunity and risk sides while insurable risks only have a negative side.
• Risk management is the systematic process of identifying, analysing, and
responding to project risk.
• The purpose of risk management is to improve project performance by
systematically identifying and assessing risks, developing strategies to
reduce or avoid them and maximising opportunities. In effect, risk
management is a creative and constructive process
14.
15.
16. Pharmaceutical quality assurance—Pharmaceutical quality assurance may be defined
as the sum of all activities and responsibilities required to ensure that the medicine that
reaches the patient is safe, effective, and acceptable to the patient.
Pharmaceutical quality control—As defined by WHO, quality control is the part of the
firm’s process concerned with medicine sampling, specifications, testing, and the
organization’s release procedures that ensure that the necessary tests are carried out and
that the materials are not released for use, nor products released for sale or supply, until
their quality has been judged satisfactory.
QC functions to test and measure material and product while QA establishes system for
ensuring the quality of the product.
17. QA & QC* Systems Evolve During Drug Development
• Quality assurance and quality control systems begin being established during early
clinical trials and involve:
• equipment validation (IQ, OQ, PQ)
• manufacturing controls and limits
• product specifications
• Process optimization continues through the development process, leading to
• identification of critical in-process control parameters
• final product specifications for QC purposes
• final process validation
• Stability
• Batches produced by the defined manufacturing process are studied at different
storage conditions to verify consistent quality and performance of the product
throughout shelf-life
• QC generally means product testing, and QA an independent review of the
results