QbD-Expert™

✨ Happy to share that till December, 2024, in the last 10+ years, QbD-Expert™ has conducted more than 150+ DoE | FQbD | PQbD | AQbD | SPC | SQC | PLM | OpEx Training Workshops & mentored-trained more than 🔲 6750+ Scientists/ Participants from 🔲 147+ Pharma/Biotech Companies in 🔲 56+ Countries We wholeheartedly thankful to our each & every industry client & all the registered participants, friends & well-wishers in this entire journey of 10+ years. Without your support it would be not possible for us to achieve this milestone of 150+ Training / Workshops / Consultancy Projects Worldwide. 🇺🇸🇨🇦🇲🇽🇧🇷🇨🇴🇦🇷🇧🇴🇧🇷🇨🇱🇨🇴🇪🇨🇬🇾🇵🇾🇵🇪🇸🇷🇺🇾🇻🇪🇯🇴🇬🇧🇫🇷🇩🇪🇪🇸🇮🇹🇹🇩🇨🇭🇵🇱🇩🇰🇳🇴🇫🇮🇦🇪🇸🇦🇴🇲🇧🇭🇪🇬🇸🇩🇳🇬🇿🇦🇯🇵🇰🇷🇨🇳🇲🇾🇦🇺🇳🇿🇹🇼🇸🇬🇧🇩🇷🇺🇰🇿🇱🇰🇳🇵

✨ Happy to share that till December, 2024, In the last 10 years, QbD-Expert™ has conducted more than 150+ DoE | FQbD | PQbD | AQbD | SPC | SQC | PLM | OpEx Training Workshops & mentored-trained more than 🔲 6750+ Scientists/ Participants from 🔲 147+ Pharma/Biotech Companies in 🔲 56+ Countries We wholeheartedly thankful to our each & every industry client & all the registered participants, friends & well-wishers in this entire journey of 10 years. Without your support it would be not possible for us to achieve this milestone of 150+ Training / Workshops / Consultancy Projects Worldwide. 🇺🇸🇨🇦🇲🇽🇧🇷🇨🇴🇦🇷🇧🇴🇧🇷🇨🇱🇨🇴🇪🇨🇬🇾🇵🇾🇵🇪🇸🇷🇺🇾🇻🇪🇬🇧🇫🇷🇩🇪🇪🇸🇮🇹🇹🇩🇨🇭🇵🇱🇩🇰🇳🇴🇫🇮🇦🇪🇸🇦🇴🇲🇧🇭🇪🇬🇸🇩🇳🇬🇿🇦🇮🇳🇯🇵🇰🇷🇨🇳🇲🇾🇦🇺🇳🇿🇹🇼🇸🇬🇧🇩🇷🇺🇰🇿🇱🇰🇳🇵

#FAQ 🔵🤝🏻🟣 How to conduct #Bridging_Studies for 505(b)(2) NDA Regulatory Submission ? #Ans Here is a step-by-step guide for conducting bridging studies: 1️⃣ #Understand the #Purpose ● Why it’s needed: Bridging studies are conducted to address differences between the reference drug & the new drug, such as formulation, dosage form, route of administration, or indications. ● Key goals: Establish comparability in terms of PK/PD, Efficacy & Safety 2️⃣ #Conduct a #Gap_Analysis ● Assess available data: Review existing published literature, preclinical studies, and clinical data on the reference product. ● Identify gaps: Identify any missing data needed to support your specific drug formulation or indication. 3️⃣ #Engage with the #FDA ● Schedule a Pre-IND Meeting to discuss the bridging strategy ○ Summary of the differences between the reference & proposed products (API, Excipients, Process); ○ Justification for reliance on the reference drug data. ○ Preliminary study design, including endpoints & population ● Obtain feedback on study requirements and design. 4️⃣ #Design the #Bridging Study Strategy ● Determine study type: Choose based on the difference/gap between the reference and the proposed drug product ○ #Pharmacokinetic (PK) #BA #BE Study: Compare plasma drug absorption, distribution, metabolism & excretion profiles for changes in dosage form or strength ○ #Pharmacodynamic (PD) studies: For drugs where clinical response is critical or where its difficult to measure plasma drug conc. ○ #Clinical #Safety & #Efficacy Study: If needed, evaluate therapeutic equivalence or address new indications. ○ #Nonclinical studies: If new toxicological data are needed for formulation changes ● #Endpoints: Define measurable objectives, such as plasma drug levels or clinical outcomes. ● #Population: Select a population that matches the intended use (healthy volunteers or patients). 5️⃣ #Submit an #IND ● Include the proposed protocol & detailed plan for the bridging study. ● Await FDA feedback or approval to proceed. 6️⃣ #Conduct the #Bridging Study ● Execute the study according to GCP/FDA standards. ● Monitor participants closely to ensure data quality and safety compliance. 7️⃣ #Analyze and #Interpret_Data ● Use appropriate statistical methods to a show that differences are #not_clinically significant or provide a rationale for extrapolation ● Evaluate whether the study results demonstrate #equivalence or support safety and efficacy. 8️⃣ #Submit the 505(b)(2) NDA ● Compile the study results with other supporting data from the reference product, literature, and prior studies. ● Provide a clear explanation of how the bridging data supports approval. 9️⃣ #Interact with #FDA During the Review ● Respond to questions or requests for additional information ● Be prepared to address any concerns about the adequacy of the bridging data 🔟 Obtain #Approval Upon successful review, the FDA may approve the new drug application under the 505(b)(2) pathway

#FAQ 🔵🟢🟡 What's the difference between #NDA Vs. #sNDA Vs. #ANDA ? #Ans: 🔵#NDA 505b1: "FULL Application" filed by INNOVATOR on the basis CMC on the basis of 1. Preclinical Animal Toxicity Safety Data 2. Clinical Trials on Human 3. Bioavailability based Efficacy Data 🟢 #sNDA / #hNDA 505b2 :often called a “hybrid application” – a blending of old and new drug information with bridging studies – in the context of seeking FDA approval of a new drug product. The 505(b)(2) is usually reserved for situations in which a modification (often an improvement) is being made to the innovator drug resulting in the creation of a whole new “drug product” – with its own exclusivity 🟡#ANDA 505 j : "Abbreviated Application" filed by GENERIC on the basis of only Bioequivalence BE study data on generic test product with respect to reference Innovator only. Preclinical (Animal) & Clinical Trial (Human) BA Data will be not required for ANDA.

#FAQ 🔵🟢🟡 What's the difference between #NDA Vs. #sNDA Vs. #ANDA ? #Ans: 🔵#NDA 505b1: "FULL Application" filed by INNOVATOR on the basis CMC on the basis of 1. Preclinical Animal Toxicity Safety Data 2. Clinical Trials on Human 3. Bioavailability based Efficacy Data 🟢 #sNDA / #hNDA 505b2 :often called a “hybrid application” – a blending of old and new drug information with bridging studies – in the context of seeking FDA approval of a new drug product. The 505(b)(2) is usually reserved for situations in which a modification (often an improvement) is being made to the innovator drug resulting in the creation of a whole new “drug product” – with its own exclusivity 🟡#ANDA 505 j : "Abbreviated Application" filed by GENERIC on the basis of only Bioequivalence BE study data on generic test product with respect to reference Innovator only. Preclinical (Animal) & Clinical Trial (Human) BA Data will be not required for ANDA.

#FAQ 📟❓️ How to select appropriate #Statistical_Test ? #Ans: Choosing the correct statistical test depends on several factors, including the [1] Type of Data (Continuous or Discrete), [2] Your Research Question (Want to check Relationship or Differences?), [3] Number of Groups being compared (2 Groups or More than 2 Groups) & [4] Distribution of your data (Normal Distribution (Parametric Test) & Nonnormal Distribution (Nonparametric Test) Here's a step-by-step guide:

👨🏻💻🛑 Today is the last date for Registration in #QbD Practical Training Workshop scheduled from 9th to 12th January 2025 along with entire Course Materials (#DoE #QbD #SPC Master Guides - Manuals - Templates - Worksheets - Calculators & Case Studies) 👩🏻💻 Last few hours left. For Registration, You can immediately Contact on: 📞💬 : +91 9904474045 (WhatsApp) 📧 : qbdexpert@gmail.com

👨🏻💻🛑 Today is the last date for Registration in #QbD Practical Training Workshop scheduled from 9th to 12th January 2025 along with entire Course Materials (#DoE #QbD #SPC Master Guides - Manuals - Templates - Worksheets - Calculators & Case Studies) 👩🏻💻🎫 Last few hours left for Registration. For Registration, You can immediately Contact on: 📞💬 : +91 9904474045 (WhatsApp) 📧 : qbdexpert@gmail.com

🧑🏻🔬🕹 4-Days Formulation & Process #QbD : Quality by Design Practical Training Workshop scheduled from 9th to 12th January 2025 along with entire Course Materials (#DoE #QbD #SPC Master Guides - Manuals - Templates - Worksheets - Calculators & Case Studies) 👩🏻🔬🎫 Last few hours left for Registration. For Registration, You can immediately CONTACT US on: 📞💬 : +91 9904474045 (WhatsApp) 📧 : qbdexpert@gmail.com

🟢🔜🟡🔜🔴 4-Days Formulation & Process #QbD Practical Training Workshop from 9th to 12th January 2025 along with all Course Materials (#DoE #QbD #SPC Master Guides - Manuals - Templates - Worksheets - Calculators & Case Studies) 👩🏻💻 🎫 Today is the last date for Registration. For Registration, You can Contact on: 📞💬 : +91 9904474045 (WhatsApp) 📧 : qbdexpert@gmail.com