Shridhar Nikam’s Post

Understanding RLD vs. Generics: What's the Difference? 🤔 In the world of pharmaceuticals, it's crucial to distinguish between Reference Listed Drugs (RLD) and generics. RLDs are the original, FDA-approved drugs that set the standard for quality, safety, and efficacy. These pioneering drugs undergo rigorous testing and clinical trials to establish their therapeutic benefits, serving as a benchmark for all subsequent versions. Generics, on the other hand, are equivalent versions that enter the market once the patent of the RLD expires. They offer the same therapeutic benefits, strength, dosage form, and route of administration as their RLD counterparts but at a significantly lower cost. This affordability is due to the reduced financial burden of not having to repeat the extensive clinical trials conducted by the original manufacturers. Instead, generics must demonstrate bioequivalence, ensuring they work in the same way and provide the same clinical benefit. Here are some key benefits of generics: Cost-Effectiveness: Generics provide more affordable treatment options, making healthcare accessible to a broader population. 💰 Quality Assurance: Generic drugs are required to meet the same rigorous standards as RLDs in terms of safety, efficacy, and quality. 🔬 Therapeutic Equivalence: Generics are bioequivalent to RLDs, ensuring patients receive the same therapeutic effect. 🩺 At Amarin, we specialize in developing high-quality generic versions of transdermal and topical brand products. Our commitment to excellence ensures that our generics meet the stringent standards set by their RLD counterparts, providing patients with safe, effective, and affordable treatment options. Have questions about RLDs and generics? Email us at info@amarintech.com.ar. We're here to help! 📩 #AmarinTech #PharmaIndustry #GenericsVsRLD #HealthcareInnovation #AffordableMedicine #PatientCare #QualityCommitment #Pharmaceuticals #TDDS

✨️The Impact of Bioequivalence Studies on Clinical Trials✨️ I would like to share this insightful article for researchers who are planning the bioequivalence study. Bioequivalence studies are important in the development and approval of generic drugs, ensuring they meet the same standards of efficacy and safety as their branded counterparts. He shows how they influence clinical trials. 1. Bioequivalence studies are a key requirement for regulatory approval, allowing generics to bypass extensive clinical efficacy trials and expedite market entry. 2. Typically designed as crossover studies, these trials focus on pharmacokinetic parameters like Cmax and AUC, ensuring the generic and reference drugs have similar bioavailability. 3. Those studies reduce the cost and time required for bringing generics to market, making medications more affordable and accessible. He also mentioned the histroy of that the FDA typically requires that the 90% confidence interval for these parameters fall within 80-125% of the reference drug for bioequivalence to be established. The 1972 FDA guideline introduced the "80/20 Rule" or "Power Approach," which aimed to ensure at least 80% power to detect a 20% difference in drug concentrations, setting a foundation for subsequent regulatory requirements. Over time, bioequivalence testing has faced challenges, such as variations in patient responses and issues with certain drug classes like chiral and poorly absorbed drugs. Please find out more attentive and insightful thoughts information through this link. https://lnkd.in/gst3Cc7U #CNR #CNRResearch #ClinicalTrials #bioequivalence #씨엔알리서치 #임상시험 #BEStudy

The challenge of low bioavailability in oral drug formulations, often stemming from poor solubility, can lead to variability, lack of dose proportionality, and therapeutic failure. Enhancing the bioavailability of drugs with these properties is a significant hurdle in drug formulations. Lipid-based formulations for oral medications are gaining attention for their ability to enhance solubility, aid in gastrointestinal absorption, and mitigate the impact of food on poorly water-soluble drugs. This advancement holds promise for increasing bioavailability. Register for the interactive training on Lipid Based Formulations using the link below. #LipidBasedFormulations #Bioavailability #LBDDS #Manufacturing #SoftGelatin #AdvancedDrugDelivery #SymmetricTraining

🌟 Breaking Ground: FDA's Implementation of M13A for Bioequivalence of Immediate-Release Oral Dosage Forms 🌟 Today's insightful SBIA webinar unveiled the U.S. FDA’s proactive steps to implement the ICH M13A guideline—a groundbreaking, harmonized framework addressing bioequivalence (BE) for immediate-release (IR) solid oral dosage forms. 🎉 💡 Key Takeaways from the Webinar: 1️⃣ Why M13A Matters: * Before harmonization, regulatory agencies like the FDA and EMA had diverging recommendations, leading to inefficiencies and redundant BE studies. * M13A promotes global consistency and reduces the burden on generic drug manufacturers, ultimately accelerating patient access to affordable medication. 2️⃣ Major Changes Introduced: A risk-based approach for BE study conditions: * High-risk products (e.g., lipid-based formulations) require both fasting and fed studies. * Non-high-risk products need only one study, depending on food-related pharmacokinetic factors. Streamlined requirements have led to revisions of 814 Product-Specific Guidances (PSGs), eliminating unnecessary studies for non-high-risk drugs. 3️⃣ Cost & Efficiency Impact: * Estimated $50 million in annual savings for generic manufacturers. * Enhanced flexibility with options like biowaivers based on the Biopharmaceutics Classification System (BCS). 4️⃣ What’s Next: * Continued revision of guidance documents, including updates to ANDA submission practices. * Ongoing discussions about pH-dependent solubility and further global alignment. 💬 Why This Is a Game-Changer: With M13A, generic drug developers can now pursue global approvals more seamlessly, saving time and resources. Patients benefit from faster access to affordable generics, while the industry experiences reduced regulatory hurdles. For anyone working in pharmaceuticals, BE, or regulatory affairs, this marks a significant shift in how we approach IR drug development. 📚 For more details, explore the FDA’s M13A guidance and Q&A resources here: FDA M13A Guidance https://lnkd.in/eAGR3_3N #ANDA #Bioequivalemce #Genric #ClinicalTrials #FDA #GDUFA

Understanding bioequivalence is essential for bringing safe, effective, and affordable generic drugs to market. Our latest blog breaks down: - What bioequivalence means in the regulatory context - How it ensures the safety and efficacy of generic drugs - Key study designs and methods for demonstrating bioequivalence Get the details and take a step closer to approval: https://lnkd.in/e6Dudkf8 #Pharma #FDA #DrugDevelopment #FormulationDevelopment #CDMO #RegulatoryServices #QualityAssurance #Bioequivalence #GenericDrugs

Biopharmaceutic Classification System(BCS) of Drug Introduction: Biopharmaceutic classification system (BCS) is an advanced tool used for classifying drug substances on dissolution, intestinal permeability and water solubility. In 1995, a theoretical approach for comparing in vitro drug dissolution with in vivo bioavailability was first conducted by Amidon et al. Biopharmaceutic Classification System: Class I - high permeability, high solubility Example: metoprolol, paracetamol Those compounds are well absorbed and their absorption rate is usually higher than excretion. Class II - high permeability, low solubility Example: glibenclamide, bicalutamide, ezetimibe, aceclofenac The bioavailability of those products is limited by their solvation rate. Class III - low permeability, high solubility Example: cimetidine The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied. Class IV - low permeability, low solubility Example: Bifonazole Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected. Importance of BCS : will reduce the cost in drug development process ,also reduce unnecessary drug exposure in healthy objects. BCS classification system is an important tool for generic drug development. It’s give a comparative evidence between test product and RLD (reference listed drug) To predict in vivo performance of drug products from in vitro measurements of permeability and solubility. #biopharmaceutic #pharmaceutic #pharmacology #pharmacist #pharmacy #medicine #health

‼️USP STIMULI ARTICLE: In–Vitro Product Performance Testing of Oral Drug Products–Views of the USP Expert Panel This is the last in a series of stimuli articles developed by the #USPExpertPanelNewAdvancements in Product Performance Testing charged with reviewing and proposing new approaches for #drugperformancetesting in the #USPharmacopeia. The USP Expert Panel created working groups that focused on five major #routesofadministration, #continuousmanufacturing, and #nanomaterials. The article reports the results of the working group that studied the performance tests for #orallyadministereddrugproducts. The goal of this article is to highlight current knowledge gaps and potential challenges associated with performance tests for certain orally administered drug products, and to stimulate public input on current practices and new advances for in vitro testing. The input received may inform the development or revision of #USP general chapters. Although #dissolutiontesting for #oralproducts is well established, periodic review and timely assessments of current procedures and possible alternatives are required to support #regulatoryapproval for new and generic drug products. To this end, USP established the Expert Panel New Advancements in Product Performance (#EPNAPPT) to review the status of drug performance tests regardless of their route of administration. This Stimuli article focuses on oral dosage forms and describes the limitations and challenges to develop dissolution methods to support #QC and biorelevant purposes. The development of various oral dosage forms requires development of robust methods and unique techniques based on the release characteristics. This Stimuli article is arranged by specific types of #solidoraldosageforms. For each dosage form there is a discussion of the #limitations and points to consider for the development of quality control or biorelevant dissolution methods. It is the intent of this Stimuli article to generate public comments on how USP can update or create new compendial chapters. Whether or not the dissolution profiles have been correlated with #biologicaleffectiveness, the standard dissolution test is a simple and inexpensive indicator of a product’s physical consistency. However, several limitations associated with the test design (e.g., apparatus, medium, volume, and timepoints) or its applicability have been identified and are discussed in this Stimuli article. Below the link to the USP WEBPAGE https://lnkd.in/d7YmgVsJ IF YOU LIKE THIS POST FOLLOW ME ON LINKEDIN

🔧 Overcoming manufacturing hurdles in the pharma sector! OcyonBio is enhancing its production capabilities to mitigate supply chain issues and ensure the availability of sterile drugs. This initiative is a significant step towards improving global healthcare. #OcyonBio #MakingMedicinesAffordable #Pharma #DrugManufacturing #SupplyChainResilience

Unlock the potential of the Indian #biosimilar market with our latest article! Gain valuable insights into navigating regulatory frameworks and market dynamics, essential for success in this rapidly evolving sector. Follow InviMeds Health for all pharmaceutical updates! #Biosimilars #IndianMarket #RegulatoryFramework #MarketDynamics #Healthcare #InviMedsHealth #invimeds https://bit.ly/3WHkP7c

𝐈𝐧 𝐒𝐢𝐥𝐢𝐜𝐨 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐚𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐅𝐫𝐚𝐦𝐞𝐰𝐨𝐫𝐤𝐬 𝐟𝐨𝐫 𝐍𝐞𝐱𝐭-𝐆𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐆𝐞𝐧𝐞𝐫𝐢𝐜𝐬💉💊 The ever-evolving pharmaceutical landscape welcomes new classes of drugs with intricate functionalities, including controlled-release mechanisms, targeted delivery systems, and formulations for poorly soluble active pharmaceutical ingredients (#APIs). These advancements offer significant therapeutic benefits, but developing generic versions of these "next-generation" drugs presents unique #challenges. Complex generic products, such as depot #formulations, liposomes, and transdermal dosage forms, require specialized #knowledge and #expertise. Depot formulations, like injectable suspensions or implants, are designed to slowly release the drug over an extended period, improving patient #compliance and #efficacy. Liposomes are lipid-based vesicles that can encapsulate drugs, enabling targeted delivery to specific tissues or cells, reducing side effects, and #enhancing bioavailability. Transdermal dosage forms, such as patches, gels, or creams, provide a non-invasive route of administration, allowing for controlled #drug release through the skin and avoiding first-pass metabolism in the liver. 🧑⚕️ ⚠️ The complex nature of these advanced drug delivery systems poses challenges for the #development of generic versions. Traditional approaches to drug formulation and evaluation may not be sufficient, and navigating the #regulatory landscape for these complex products adds another layer of complexity. Pharmaceutical companies must carefully consider the specific characteristics of these complex generic products and develop innovative #strategies to address the unique challenges in order to bring #safe and effective generic versions to the market. 📈 𝗜𝗻𝗦𝗶𝗹𝗶𝗰𝗼𝗠𝗶𝗻𝗱𝘀 𝗯𝗿𝗶𝗱𝗴𝗲𝘀 𝘁𝗵𝗲 𝗴𝗮𝗽 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗰𝘂𝘁𝘁𝗶𝗻𝗴-𝗲𝗱𝗴𝗲 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗮𝗻𝗱 𝗲𝘀𝘁𝗮𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸𝘀, 𝗲𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗼𝗳 𝘀𝗮𝗳𝗲, 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲, 𝗮𝗻𝗱 𝗮𝗳𝗳𝗼𝗿𝗱𝗮𝗯𝗹𝗲 𝗻𝗲𝘅𝘁-𝗴𝗲𝗻𝗲𝗿𝗮𝘁𝗶𝗼𝗻 𝗴𝗲𝗻𝗲𝗿𝗶𝗰 𝗱𝗿𝘂𝗴𝘀. Our suite of in silico solutions empowers development strategies for complex generics while staying aligned with FDA guidelines and recommendations. The FDA recognizes the importance of fostering the development of complex generic drug products and prioritizes research to develop methods and approaches for establishing the sameness and bioequivalence of these products. ✨ InSilicoTrials #InSilicoFormulation #ComplexGenerics #QbD #BCS #TargetedTherapy #PBPK #FDA #Biopharmaceutics #InSilicoMinds #M&S #VirtualBE #Bioequivalence