How do I access BioPhyRx?

Once you receive your login credentials, please go to https://biophyrx.ai and enter your username and password.

Why did the BioPhy team create BioPhyRx?

In working closely to provide AI drug development solutions to our life sciences clients, we identified a significant inefficiency limiting their scientific and clinical research: overwhelmingly numerous and fractured data sources that often could only be accesses through clunky, outdated search tools. With this universal pain point in mind, we created BioPhyRx, an advanced, specialized generative AI solution designed to create a centralized, intuitive research tool that enables researchers to access the scientific and regulatory resources they need with unprecedented speed and ease.

What is BioPhyRx?

BioPhyRx, the BioPhy Generative Drug Development AI, can help you with drug development and FDA regulations by analyzing and interpreting scientific literature, clinical trials, FDA guidelines, policies, and documents to provide accurate and up-to-date information on regulatory requirements for industries and individuals involved in the development, manufacturing, and distribution of drugs, medical devices, and other FDA-regulated products.

• Stay on top of the current science: BioPhyRx can help you understand the latest and most relevant research and findings in drug development.

• Navigate complex regulations: BioPhyRx can provide you with a clear explanation of the FDA's expectations and requirements for drug development.

• Informed decision-making: BioPhyRx can provide guidance on best practices and strategies for the development, manufacturing, and distribution of drugs, medical devices, and other FDA-regulated products.

• Broader reach: BioPhyRx can assist in helping you quickly gain a working understanding of the implications of scientific research in a large variety of therapeutic areas and disease states.

• Trusted sources: BioPhyRx provides direct links to reputable outside sources for each answer to preclude any “hallucination” of non-existent data.

How do I best use BioPhyRx?

To best use BioPhyRx, the BioPhy Generative Drug Development AI, follow these steps:

1. Clearly state your question or topic: Begin by asking a specific question or stating a topic related to drug development, FDA guidelines, clinical trials, or regulatory requirements. This will help BioPhyRx understand your needs and provide a more accurate and relevant response.

2. Provide relevant information: If you have any background information or context related to your question, please include it in your query. This will help BioPhyRx tailor its response to your specific situation.

3. Be prepared for multiple explanations: BioPhyRx may provide multiple explanations or interpretations based on the information provided. This is to ensure that you receive a comprehensive answer to your question.

4. Review the sources provided: BioPhyRx will provide a list of sources used to answer your question, including the issued date, status, and link to each source. Review these sources to gain a deeper understanding of the topic and to verify the information provided.

5. Ask follow-up questions: If you have any additional questions or need clarification on any part of the response, feel free to ask follow-up questions. BioPhyRx is here to help you gain a thorough understanding of the topic. If you receive an unexpected response, please try rephrasing the question or providing additional context.

6. Be creative: If you need help brainstorming ideas or solutions related to drug development or FDA regulations, BioPhyRx can assist you in generating creative and innovative ideas.

7. Explore suggested questions: BioPhyRx may provide suggestions for other questions that could be helpful in understanding the topic. Consider asking these questions to gain a more comprehensive understanding.

Remember, BioPhyRx is passionate about sharing knowledge and assisting you in navigating the complex world of drug development and FDA regulations.

What does BioPhy do with user data?

BioPhy cares about your privacy and our intention is to use the information we collect to improve user experience overall by creating new features. We will not sell your personally identifiable information to third parties without your consent. Please see our Privacy Policy for further information.

Sample questions:

Below is a list of sample questions that BioPhyRx, the BioPhy Generative Drug Development AI can help with:

• What are the key regulatory requirements for conducting a Phase 1 clinical trial for a new drug?

• What are the critical quality attributes that must be considered during the manufacturing of a biologic drug product?

• How does the FDA evaluate the safety and efficacy of a new medical device before granting approval for sale to the public?

• What are the main differences between the 505(b)(1) and 505(b)(2) pathways for new drug applications (NDAs)?

• Can you provide an overview of the FDA's Risk Evaluation and Mitigation Strategies (REMS) for certain drug products?

• What are the key considerations for designing a pediatric clinical trial, and how does the FDA ensure the safety of pediatric participants?

• How does the FDA regulate the use of real-world evidence in the approval process for new drugs and medical devices?

• What are the main regulatory requirements for the development and approval of combination products (drug-device, biologic-device, or drug-biologic combinations)?

• Can you explain the FDA's guidance on the development of gene therapies and their approval process?

• Can you explain the different phases of clinical trials and their objectives?

• What are the main factors to consider when designing a clinical pharmacology study?

• How do drug-drug interactions impact the safety and efficacy of a medication?

• What are the critical aspects of chemistry, manufacturing, and control (CMC) in drug development?

• How do intrinsic and extrinsic factors affect the pharmacokinetics and pharmacodynamics of a drug?

• Can you provide an overview of the FDA's guidelines for the development of drug-device combination products?

• How do regulatory agencies assess the safety and efficacy of biologic products, such as monoclonal antibodies and recombinant proteins?

• What are the key considerations for the development and approval of orphan drugs for rare diseases?

How do the filters in BioPhyRx work?

Filter Definitions:

• Biomedical Literature – 36M+ Pubmed abstracts; published dates

• FDA Regulatory Guidance – Last 40 years of FDA guidance; published dates

• FDA Drug Submissions – Drug labels, SBAs, and other forms; submitted dates

• FDA Device Submissions – Premarket Approvals, Approval Order, Summary of Safety and Effectiveness, and Labeling Documents

• Clinical Trials – 450,000+ clinical trials; trial start dates

• CFRs – Code of Federal Regulations

• EMA Regulatory Guidance – Last 20 years of EMA guidance; published dates

• EMA Submissions – EPARs, Summary Opinions, and other forms; submitted dates

• The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

What are the latest updates?

As of December 31, 2023, the BioPhyRx Labs is also available.

How do I provide feedback?

Please email feedback@biophy.ai