Conference Talk

Technologies to Improve Solubility/Dissolution Rate and Oral Bioavailability of Poorly Soluble Drugs

Sudhakar Garad
Sudhakar Garad, Global Head, Chemical and Pharmaceutical Profiling, Novartis

Talk Abstract: Dosage form (formulation) and enabling technologies to play a vital role in the success of new chemical entities transitioning from preclinical to clinical development through commercialization. The majority of new chemical entities being discovered in many disease areas have a poor aqueous and bio-relevant solubility. These are often available in the amorphous and chemically impure form of in-vitro enzyme assays, pharmacokinetic, pharmacological and toxicological studies in animal models.  These molecules are often dosed as a suspension/solution orally/parenterally respectively and candidate selection is based on results obtained from these studies. Therefore, it is very important to select a physical form as early as possible so that the same form can be used for preclinical and clinical studies, as changes in physical form or formulation principle could significantly affect the pharmacokinetic performance and formulation characteristics (i.e. stability/solubility/compatibility) and toxicity. The selected candidate must exhibit adequate physical and chemical stability during the formulation development process with desirable pharmacokinetic parameters. If pharmacokinetics parameters of these molecules are different due to different physical form or formulation selection, a significant delay may occur during development. It’s important to explore enabling technologies with existing molecules depending on the clinical/market need.  This presentation will cover early formulation strategies and novel technologies to improve the bioavailability of poorly soluble drugs.

Let us meet and see what new technologies Dr Sudhakar Garad, from Novartis, USA wishes to share with us. Register today for Novel Formulation Strategies

For more details, please contact Ms Shivalika Patial by Email – or Call at 8283815050 or Whatsapp at 9041725050


What will make it an Overwhelming QbD Conference?

Dear Colleagues,

Many of you wonderful scientists must be having one or more of the following questions in your mind.

What is different in this QbD conference?

I have attended so many QbD conferences, why one more??

QbD is same always, what is new in this conference???

I am from XYZ department, will I gain anything????

I am busy, how should I take out time for this conference?????

However, we wish to tell you that our “QbD in Pharma Developement World Congress 2015 ” is going to be a great conference.  We have done efforts to make this conference the best possible with several happenings which have never been collectively there before at any QbD conference viz Problem Solving Software Training and discussion on the following and many more topics.

  • Question based Review and Continued Process Verification
  • Question based Approach to Product Development
  • Integration of Quality by Design from Product Development to API Production
  • Methods to Minimize the Impact of Uncertainty in Pharma Quality Attributes
  • Realization of Quality by Design in ANDA Submissions
  • How to Demonstrate the Relevant Diligence on Filing
  • Risk Based Approach for Efficient Development of the DS Control Strategy
  • QbD & QbR to Reduce Health Care Cost while Maintaining Quality
  • How to find the Robust Setpoint for Design Space Combining DOE Models, Monte Carlo Simulations and Design Space Concept
  • ATP and CQA For Analytical Methods
  • Risk Assessment In Aqbd and Design Space for Analytical Methods
  • Tools that Play a Critical Role in Implementation of Qbd for Biotech Processes
  • Five-D Concept of QbD
  • Live Demonstration on How to Utilize Tools of Qbd i.e. DoE & PAT
  • Industry Case-Studies Related to Implementation of PAT
  • How To Implement DoE & PAT Systematically & Effectively during Development & Manufacturing of Solid Oral/Liquid Orals/ Semisolids & Parenteral Dosage Forms
  • DoE for Development of a Modified-Release Tablet
  • Advanced DoE for Improved Process Understanding
  • Statistics in Product Development – Beyond DoE
  • Use of other Statistical Tools to Build Robust Products & Processes
  • Chemometric Tools in QbD -Chemometric Methods & their Advantages and Principle
  • QbD Based Systematic Development of Nanoemulsions for Natural Product
  • Analytical Quality By Design (Aqbd) Approach In RP-HPLC Method Development
  • Quality By Design (QbD) Approach in Formulation of Oral Delayed Release Tablet of LansoprazolFor details, please find attached the agenda of the conference. Looking into the above topics being covered, we feel that we have the answers to the above questions
  •  You were looking for the best QbD scientists and there they are.
  • This is not like the earlier conferences since the quality of talks is exceptionally high and specifically meant to enhance your process and product understanding.
  • QbD has to be implemented holistically and if you are a scientist from Quality assurance, Analytical development, API Development or Formulation Development, it is relevant for you.
  • You are entrusted with responsibility to develop products and processes of high quality for effective ANDA filings and that exactly the aim of this conference is.
  • You spend lot of time in sorting out QbD data related problems which your colleagues must be facing. Be there, get your data problems solved and save time.
  • Finally get tips on how to develop medicine in cost effective manner and give your company a return which is much higher than investment in this conference.

So what are you waiting for? Register now

Our worthy Speakers and we all will be doing our best and Now it is your presence which will make it an Awesome Conference.!!!

Looking forward to see you in Chandigarh.

How Question Based Development can Demonstrate Quality by Design and how it can Facilitate Continued Process Verification??

Ajaz Hussain2

How Question Based Development can Demonstrate Quality by Design and how it can Facilitate Continued Process Verification??

Recent organizational changes at CDER/FDA have created a new ‘supper’ Office of Pharmaceutical Quality to improve information and knowledge sharing and decision- making; (a) within New and Generic CMC Review function, and (b) between CMC Review and CGMP Compliance functions.  ‘Question based Review’ and ‘Continued Process Verification’ are two themes can be expected to have a significant impact over the next several years on how product development, validation and manufacturing is carried out in industry and how FDA will review and inspect these functions.

If the above issue is important for you and you would like to be enlightened on the same you ought to be in Chandiarh for “QbD in Pharma Development World Congress 2015” on April 16, 2015 in Chandigarh. Dr Ajaz Hussain, Former FDA Reviewer and Currently Executive Director, NIPTE, USA will be there to address this issue and many more.

Just SMS QbD at 7696125050 and we will get back to you with more details.

Obsessed with QbD – Learn 20 Astonishing Tools from World Leaders

Obsessed with QbD – Learn 20 Astonishing Tools from World Leaders at QbD in Pharma Development World Congress on April 16-18, 2015 in Chandigarh, India.

The conference i.e. QbD in Pharma Development World Congress, will have an exclusive one day Software Training/Workshopon April 18, 2015. A series of workshops will be conducted by experts from different software developing organizations. The experts will impart hands-on training on different aspects of the commercially available software for implementation of QbD principles in Pharmaceutical & Biotech Industry.

All registered conference delegates can attend this workshop and no additional fee is required for attending the same. However, Pre-Registration is necessary. Seats will be reserved (For Workshop) on First-Come-First-Served basis. The registered participants will be provided software before hand and would need to carry their laptops in the workshop for hands-on training.



  1. Selection of goals, factors, responses
  2. Type of model and design
  3. Choosing and adapting a design
  4. Set specifications for a Design Space
  5. Screening to Optimizing factors
  6. Identifying Operating Regions that assure Good Quality Product.
  7. Robustness Testing & its Verification
  8. Full factorial DOE & Gage RR Study
  9. Interpreting the Analysis Report
  10. Visualizing the results
  11. Variable scaling, geometrical interpretation, and model evaluation
  12. Utilizing Multivariate Data Analysis (MVDA), Principal Component Analysis
  13. Partial Least Squares (PLS) for relating predictors and response
  14. Model diagnostics and validation of a PLS and OPLS model
  15. Batch Modeling using historical Production Batches
  16. Real time Problem solving
  17. Desirability, Combining responses & Specifying a mixture problem
  18. Data examples from Pharma, Biopharma industry
  19. Case Studies: Development to Manufacture, API Synthesis, Formulation Design
  20. Monitoring Design Space at Production Level