Early drug formation
19 important questions on Early drug formation
What is the EU definition of the pharmaceutical development?
In a short way: Helps to better understand the nature/ design of the product
- gives a scientific overview of the product
What kind of information is gathered during the pharmaceutical development?
- optimization (critical elements)
- verification studies
Actually you show that you are able to produce the drug according to the requirements.
What are the key elements in the preformulation?
- Small scale tests
- Time to evaluate results
- Reporting of results and conclusion with a focus on future dosage from development
- Communication of results to people involved in further development
- Threads to preformulation: No regulatory requirements, Costs, time and capacity.
- Higher grades + faster learning
- Never study anything twice
- 100% sure, 100% understanding
For my 1st exam I got a C. Then, I started looking for ways to learn better and I came across Study Smart. Since then I have scored a A+, A, A- and another A. I highly recommend it to everyone who wants to hear it. I am so happy with it!!
I was struggling to finish all my first-year subjects for 3 years. Then I discovered Study Smart, which helped me to finish all of them within 3 months.
Because of StudySmart, things are going well in many ways. Before, I always had study stress and no time for anything. Now I feel calm and confident (because of the program). I used to score a B, now I usually score an A or A+.
Hey Chris, I really want to thank you very much for developing the platform, I usually got around C for my exams, now I scored an A+, an A and a A- !!
Since using Study Smart, my average has increased significantly. I even completed a statistics course with a A+ while I'm bad at statistics. I took on extra courses this year, because of Study Smart. Thanks so much!
Ever since I started studying with StudySmart I passed all my exams !!! No more re-sits!! At first, I was happy with a pass and now I only get good grades. Many thanks!
I aced all the courses I studied with Study Smart. For law, I first scored a D, and now an A! I’m 100% sure that I’ll pass all the courses I study with Study Smart.
I always thought I studied well. My grades were fine. I could never have imagined that applying these study skills would have such a huge and direct impact on my grades, my speed and the pleasure I have in learning.
For the first time, I finally feel totally confident about the way I learn. I have the perfect overview and make great progress in terms of speed and the grades I get. Thanks, Chris!
I immediately started to enjoy learning again, and my grades soared. All of a sudden, everything went better. I highly recommend Study Smart to all students..
Being able to create my materials online made the process of studying so much smoother and quicker. I no longer have to spend a huge amount of my time on creating my summaries.
At first, my notes were a mess. Now I use Study Smart to take my notes in a perfectly structured way. It helps me to save a lot of time and do other things I enjoy.
Students that study with Study Smart get better grades. The system applies all the learning methods in such a way that both well-performing students and students who struggle perform much better.
Hi Chris, I would like to thank you very much. Last year I scored C on a course, and this year I got an A+ thanks to your method! Thank you very much!
The largest effect is that my child is more enthusiastic about school! Every parent wants their children to be happy at school, Study Smart made it happen.
In high school, I failed several exams, and that has really changed now. I actually needed this tool very much back then. Since I started studying with StudySmart, I haven't had any D's. My average score is now an A and those are results I would have never had in the past
With my old method, I passed only 3 out of 8 courses. Since I started taking my notes digitally in Study Smart, I have passed all my courses on the first try. For me, StudySmart takes away the stress of wondering if I will pass or not.
Thanks to StudySmart, I passed all my exams, and with better grades than before! On top of that, I have mastered a very good study method now, which I am confident will help me earn my degree.
What are the characteristics of the solution?
- pH stability profile: degradation above pH 5.5
- effect of co-solvents
- sterilisation: no heat sterilisation possible
What are the characteristics of a solid?
- specific surface area: 1,5 M2/g (large)
- flow properties: poor
- compaction: poor binding properties
- contact angle: 77 degrees
- intrinsic dissolution rate: 1.5 ug/cm2/min
- polymorphism: no
- No thermal explosion risk
What are the characteristics of the development of the first clinical formulation?
- It is a choice for a composition and a process based on limited experimental work.
- It is a combined activity of dosage form development and analytical development
- limits are: time, amount of drug substance, wide range of dosage strength.
Where does the development of the first clinical formulation rely on?
- experience with the dosage form, scientific knowledge on the dosage form
- downscaling (types of apparatus) and bracketing
- qualified and skilled personnel.
- good science from preformulation and compatibility
What is the target product profile?!
What are the specifications of the clinical capsule?
What are prerequisites of a first clinical production?
- cleaning must be proper
- Documentation
What are potential problems in the first clinical production?
- changes in handling
- changes in equipment, scale and environment
- changes in dosage strength
- changes in drug substance
How is the prevention of problems?
- Use formulations and technology with which experience exists and on which scientific knowledge is available
- clear and concise protocols and instructions
- adequate communication
- realistic setting of specifications and IPC's based on previous development work and previous experience with similar products and processes
When to start with the clinical studies with the market formulation?
- after central clinical studies: more time for development, more information available at the start, limited scale up and validation of the clinical form.
How is the market formulation developed?
- Develop analytical methods
- Use the PAR approve (The proven acceptable range)
- Work at laboratory scale
- Re-define your requirements
How do you optimize the formulation and the process?
Why a 10% production scale is necessary?
What kind of validation/qualifications are there?
- installation qualification
- operational qualification (calibration
- process validation
- cleaning validation
How does the process validation flow-scheme go?
2) optimisation to find critical parameters
3) scale up
4) write validation protocol
5) review and approval (here it can also become rejected)
6) execution
7) analysis, data acquisition
8) reporting
9) data review (by a qualified person)
10)acceptance or rejection (big problem)
11) change control and revalidation
What are the reasons to apply GMP during development?
- To improve R&D operations
- To ensure integrity of data
- To increase the change for regulatory sucess
- To ensure integrity of toxicological and clinical data
- to improve the quality of the production
- to reduce the overall costs.
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
