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# aibio.pro

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## Posts

- [Hello world!](https://aibio.pro/hello-world-2/) - Welcome to Astra Starter Templates. This is your first post. Edit or delete it, then start blogging!
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## Pages

- [Home](https://aibio.pro/) - Welcome To AIBIO.PRO At AIBIO.PRO, we empower biotech and pharmaceutical companies with AI-driven solutions to accelerate innovation and streamline research and development. As the digital platform of AIBIO AB, we specialize in integrating artificial intelligence into drug discovery, biologics design, and pharmaceutical development, helping organizations harness the full potential of AI in life sciences. Our
- [About Me](https://aibio.pro/about/) - About AIBIO.PRO: Driving Innovation in BiotechAt AIBIO.PRO, we are committed to empowering life sciences through innovation and collaboration. As a project under AIBIO AB, we focus on bringing cutting-edge biotechnology solutions to the European market, helping researchers and clinicians achieve breakthroughs in molecular diagnostics, drug discovery, and healthcare technologies.Our mission is to bridge the gap
- [Privacy Statement](https://aibio.pro/privacy-statement-for-aibio-studio/) - Effective Date: [December 1, 2024] IntroductionWelcome to Aibio.Studio! Protecting your privacy is important to us. This Privacy Statement explains how we collect, use, and protect your personal information when you interact with our website. By using Aibio.Studio, you agree to the practices described in this policy. 1. Information We Collect We may collect and process
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- [The AI Revolution in Drug Discovery](https://aibio.pro/the-ai-revolution-in-drug-discovery/) - The field of drug discovery is undergoing a remarkable transformation, driven by rapid advancements in artificial intelligence (AI) and computational biology. In recent years, breakthroughs like AlphaFold2 have redefined our approach to understanding protein structures and interactions—one of the most challenging aspects of designing new therapeutics. By accurately predicting protein folding, AlphaFold2 has paved the
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## Products

- [The pharmacological studies](https://aibio.pro/product/the-pharmacological-studies/) - The pharmacological studies offered for a wide range of large and small animal disease models. Key disease categories include: Immuno-Oncology: Studies focused on cancer treatment involving immune system modulation. Autoimmune Inflammation: Research targeting disorders like rheumatoid arthritis or lupus. Metabolic/Liver Diseases: Including diabetes and non-alcoholic fatty liver disease (NAFLD). Cardiovascular Diseases: Addressing heart and vascular-related conditions.
- [ABS241003](https://aibio.pro/product/abs241003/) - ABS241003 binds to CXCR4, preventing its interaction with CXCL12 and thereby disrupting the signaling pathway that typically promotes cancer cell migration and survival. By inhibiting this interaction, ABS241003 may hinder metastatic progression and enhance the effectiveness of other therapeutic interventions. This mechanism suggests that ABS241003 could be a valuable addition to cancer therapy regimens, particularly in strategies aimed at preventing metastasis and reducing tumor spread.
- [ABS241002](https://aibio.pro/product/abs241002/) - ABS241002 binds to PDL1 and prevents its interaction with PD-1, thus disrupting the immune checkpoint mechanism that typically suppresses the immune response. By inhibiting this interaction, ABS241002 can potentially restore T cell function and promote an anti-cancer immune response, making it a promising candidate for cancer immunotherapy. This mechanism positions ABS241002 as a strong contender for therapeutic applications aimed at enhancing immune activity against cancer cells.
- [GLP-1 (Glucagon-like Peptide-1)](https://aibio.pro/product/glp1/) - GLP-1 (Glucagon-like Peptide-1) is a powerful hormone that plays a pivotal role in glucose regulation and appetite control. By binding to its receptor, GLP-1 triggers a cascade of metabolic effects, making it a key target for therapies in diabetes and obesity management.
- [Pharmacological Study Services for Autoimmune Inflammation](https://aibio.pro/product/pharmacological-study-services-for-autoimmune-inflammation/) - Pharmacological Study Services for Autoimmune Inflammation BioMed Linkage collaborates with leading Chinese top-tier CROs to deliver comprehensive pharmacological study services tailored to autoimmune inflammation research. Our services focus on providing high-quality in vivo and in vitro data to support drug discovery, development, and regulatory submissions. Here's how we can support your project: Disease Models: Access
- [The safety assessment services](https://aibio.pro/product/the-safety-assessment-services/) - The safety assessment services offered by BioMed Linkage, categorized into IND-enabling Studies and NDA-enabling/Post-market Studies. IND-enabling Studies: General Toxicology: Studies conducted in rodents, rabbits, dogs, NHPs, and minipigs for 14-day and 28-day durations. Genetic Toxicology: Includes tests such as Ames, Chromosomal Aberration, Micronucleus, MLA, and Comet assays. Safety Pharmacology: Covers screening and core battery studies.
- [The CRDMO services](https://aibio.pro/product/the-crdmo-services/) - The CRDMO (Contract Research, Development, and Manufacturing Organization) services provided by BioMed Linkage. These services are categorized into four main areas: API (Active Pharmaceutical Ingredient): Process R&D and manufacturing for various products, including monomers, ligands, small molecules, oligos, peptides, unnatural amino acids, conjugates, ADCs (Antibody-Drug Conjugates), antibodies, AAV (Adeno-Associated Virus), and mRNA. Drug Product: Comprehensive

## Docs

- [ADDENDUM TO S1B(R1)](https://aibio.pro/docs/addendum-to-s1br1/) - ADDENDUM TO TESTING FOR CARCINOGENICITY FOR PHARMACEUTICALS PREAMBLE This Addendum is to be used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines. 1. INTRODUCTION 1.1 Scope of the Addendum This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in Guideline S1A. For biotechnology-derived pharmaceuticals, refer to Guideline S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. 1.2 Purpose of the Addendum This Addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in
- [S9](https://aibio.pro/docs/s9/) - NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS 1. INTRODUCTION 1.1 Objectives of the Guideline The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options. This guideline aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals, in accordance with the 3R principles (reduce/refine/replace), and other resources. As appropriate, the principles described in other ICH guidelines should be considered in the development
- [S12](https://aibio.pro/docs/s12/) - 1. INTRODUCTION 1.1. Objectives of the ICH S12 Guideline The objective of this guideline is to provide harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products. This document provides recommendations for the overall design of nonclinical BD assessments. Considerations for interpretation and application of the BD data to support a nonclinical development programme and the design of clinical trials are also provided. The recommendations in this guideline endeavour to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. 1.2. Background An understanding of the BD profile of a GT product following in vivo administration is an important element of the nonclinical development programme. BD data contribute to the inter- pretation and design of nonclinical pharmacology and toxicology studies conducted to support early-phase clinical trials in the target population. Although guidelines that include recommen- dations for BD studies have been issued by various regulatory authorities, this document pro- vides a harmonised definition for nonclinical BD and conveys overall considerations for as- sessing
- [S1A](https://aibio.pro/docs/s1a/) - GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 1. INTRODUCTION The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. Any cause for concern derived from laboratory investigations, animal toxicology studies, and data in humans may lead to a need for carcinogenicity studies.
- [S1B(R1)](https://aibio.pro/docs/s1br1/) - 1. OBJECTIVE This document provides guidance on approaches for evaluating the carcinogenic potential of pharmaceuticals. 2. BACKGROUND Historically, the regulatory requirements for the assessment of the carcinogenic potential of pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of long-term carcinogenicity studies in two rodent species, usually the rat and the mouse. Given the cost of these studies and their extensive use of animals, it is in keeping with the mission of ICH to examine whether this practice requiring long term carcinogenicity studies in two species could be reduced without compromising human safety. This guideline should be read in conjunction with other guidelines (see Annex), especially: S1.A:Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. S1.C:Dose Selection for Carcinogenicity Studies of Pharmaceuticals. Long-term rodent carcinogenicity studies
- [S1C(R2)](https://aibio.pro/docs/s1cr2/) - DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 1. INTRODUCTION Traditionally, carcinogenicity studies for chemical agents have relied upon the maximally tolerated dose (MTD) as the standard method for high dose selection (Note 1). The MTD is generally chosen based on data derived from toxicity studies of 3 months' duration. In the past, the criteria for high dose selection for carcinogenicity studies of human pharmaceuticals have not been uniform among international regulatory agencies. In Europe and Japan, dose selection based on toxicity endpoints or attaining high multiples of the maximum recommended human daily dose (>100x on a mg/kg basis) has been accepted. However, in the United States, dose selection based on the MTD has traditionally been considered the only appropriate practice. All regions have used a maximum feasible dose as an appropriate endpoint. For pharmaceuticals with low rodent toxicity, use of the MTD can result in the administration of very large doses in carcinogenicity studies, often representing high multiples of the clinical dose. This has led to the concern that exposures in rodents greatly in excess of the intended human exposures might not be relevant to human risk; because they so greatly alter the physiology of the test species, the findings might not reflect what would occur following human exposure. Ideally, the doses selected for rodent bioassays for pharmaceuticals should provide an exposure to the agent that (1) allows an adequate margin of safety over the human therapeutic exposure, (2) is tolerated without significant
- [S2(R1)](https://aibio.pro/docs/s2r1/) - GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE 1. INTRODUCTION 1.1 Objectives of the Guideline This guidance replaces and combines the ICH S2A and S2B Guidelines. The purpose of the revision is to optimize the standard genetic toxicology battery for prediction of potential human risks, and to provide guidance on interpretation of results, with the ultimate goal of improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material. The revised guidance describes internationally agreed upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment
- [S3A](https://aibio.pro/docs/s3a/) - NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES 1. Introduction This Note for Guidance concerns toxicokinetics only with respect to the development of pharmaceutical products intended for use in human subjects. In this context, toxicokinetics is defined as the generation of pharmacokinetic data, either as an integral component in the conduct of non-clinical toxicity studies or in specially designed supportive studies, in order to assess systemic exposure. These data may be used in the interpretation of toxicology findings and their relevance to clinical safety issues (see Note 1 for definitions of other terms used in this document). The Note for Guidance has been developed in order to provide an understanding of the meaning and application of toxicokinetics and to provide guidance on developing test strategies in toxicokinetics. The guidance highlights the need to integrate pharmacokinetics into toxicity testing, which should aid in the interpretation of the toxicology findings and promote rational study design development. Toxicokinetic measurements are normally integrated within the toxicity studies and as such are described in this document as 'concomitant toxicokinetics' (Note 1). Alternatively, data may be generated in other supportive studies conducted by mimicking
- [S3B](https://aibio.pro/docs/s3b/) - PHARMACOKINETICS: GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to the three regulatory parties to ICH Introduction A comprehensive knowledge of the absorption, distribution, metabolism and elimination of a compound is important for the interpretation of pharmacology and toxicology studies. Tissue distribution studies are essential in providing information on distribution and accumulation of the compound and/or metabolites, especially in relation to potential sites of action; this information may be useful for designing toxicology and pharmacology studies and for interpreting the results of these experiments. In the EC, US and Japan, there has been a general agreement on the need to conduct single dose tissue distribution studies as part of the non-clinical programme. These studies often provide sufficient information about tissue distribution. There has been no consistent requirement for repeated dose tissue distribution studies. However, there may be circumstances when assessments after repeated dosing may yield
- [S4](https://aibio.pro/docs/s4/) - DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING) ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 2 September 1998, this guideline is recommended for adoption to the three regulatory parties to ICH 1. OBJECTIVE The objective of this guidance is to set out the considerations that apply to chronic toxicity testing in rodents and non rodents as part of the safety evaluation of a medicinal product. Since guidance is not legally binding, an applicant may submit justification for an alternative approach. 2. SCOPE This guidance has been prepared for the development of medicinal products with the exception of those already covered by the ICH Guideline on Safety Studies for Biotechnological Products, e.g., Monoclonal antibodies, recombinant DNA proteins. 3. BACKGROUND During the
- [S5(R3)](https://aibio.pro/docs/s5r3/) - DETECTION OF REPRODUCTIVE AND DEVELOPMENTAL TOXICITY FOR HUMAN PHARMACEUTICALS S5(R3) ICH Consensus Guideline TABLE OF CONTENTS TABLE OF CONTENTS LIST OF ABBREVIATIONS 6 1. INTRODUCTION & GENERAL PRINCIPLES 7 1.1. AIM OF STUDIES 7 2. SCOPE OF THE GUIDELINE 8 3. GENERAL CONSIDERATIONS ON REPRODUCTIVE TOXICITY ASSESSMENT 8 3.1. TARGET PATIENT POPULATION/ THERAPEUTIC INDICATION CONSIDERATIONS 9 3.2. PHARMACOLOGY CONSIDERATIONS 9 3.3. TOXICITY CONSIDERATIONS 9
- [S6(R1)](https://aibio.pro/docs/s6r1/) - PART I: PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 16 July 1997, this Guideline is recommended for adoption to the three regulatory parties to ICH 1. INTRODUCTION 1.1 Background Biotechnology-derived pharmaceuticals (biopharmaceuticals) were initially developed in the early 1980s. The first marketing authorisations were granted later in the decade. Several guidelines and points-to-consider documents have been issued by various regulatory agencies regarding safety assessment of these products. Review of such documents, which are available from regulatory authorities, may provide useful background in developing new biopharmaceuticals. Considerable experience has now been gathered with submission of applications for biopharmaceuticals. Critical review of this experience has been the basis for development of this guidance that is intended to provide general principles for designing scientifically acceptable preclinical safety evaluation programs. 1.2 Objectives Regulatory standards for biotechnology-derived pharmaceuticals have generally been comparable among the European Union, Japan and United States. All regions have adopted a flexible, case-by-case,
- [S7A](https://aibio.pro/docs/s7a/) - SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS 1. INTRODUCTION 1.1 Objectives of the Guideline This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guideline provides a definition, general principles and recommendations for safety pharmacology studies. 1.2 Background Pharmacology studies have been performed worldwide for many years as part of the non- clinical evaluation of pharmaceuticals for human use. There have been, however, no internationally accepted definitions, objectives or recommendations on the design and conduct of safety pharmacology studies. (Note 1) The term “safety pharmacology studies” first appeared in the ICH topics, “Timing of Non- Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (M3)” and “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6)” as studies that should
- [S7B](https://aibio.pro/docs/s7b/) - THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS 1. INTRODUCTION The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (non- clinical and clinical) are accumulated in the future, they will be evaluated and this guideline might be revised. 1.1 Objective of the Guideline This guideline describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. This guideline includes information concerning non-clinical assays and integrated risk assessments. 1.2 Background The QT interval (time from the beginning of the QRS complex to the end of the T wave) of the electrocardiogram (ECG) is a measure of the duration of ventricular depolarization and repolarization. QT interval prolongation can be congenital or acquired (e.g., pharmaceutical-induced). When ventricular repolarization is delayed and the QT interval is prolonged, there is an increased risk of ventricular tachyarrhythmia, including torsade
- [S8](https://aibio.pro/docs/s8/) - IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS 1. INTRODUCTION 1.1 Objectives of the Guideline The objectives of this guideline are to provide (1) recommendations on nonclinical testing approaches to identify compounds which have the potential to be immunotoxic, and (2) guidance on a weight-of-evidence decision making approach for immunotoxicity testing. Immunotoxicity is, for the purpose of this guideline, defined as unintended immunosuppression or enhancement. Drug-induced hypersensitivity and autoimmunity are excluded. 1.2 Background Evaluation of potential adverse effects of human pharmaceuticals on the immune system should be incorporated into standard drug development. Toxicity to the immune system encompasses a variety of adverse effects. These include suppression or enhancement of the immune response. Suppression of the immune response can lead to decreased host resistance to infectious agents or tumor cells. Enhancing the immune response can exaggerate autoimmune diseases or hypersensitivity. Drug or drug-protein adducts might also be recognized as foreign and stimulate an anti-drug response. Subsequent exposures to the drug can lead to hypersensitivity (allergic) reactions. Much of the science and method development and validation efforts in the past have been focused on evaluating drug development candidates for their potential for either immunosuppression or contact sensitization. No standard approaches for human pharmaceuticals are currently available for testing for respiratory or systemic allergenicity (antigenicity) or drug-specific autoimmunity; testing for these endpoints is not currently required in any region. There are no regional differences in testing approaches of skin sensitization. Immunosuppression or enhancement can be
- [S11](https://aibio.pro/docs/s11/) - 1. INTRODUCTION 1.1 Objectives of the Guideline The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of pharmaceuticals intended for paediatric use. Harmonisation of the guidance for nonclinical safety studies will define the current recommendations and reduce the likelihood that substantial differences will exist among regions. It should facilitate the timely conduct of paediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles. 1.2 Background Guidelines have previously been issued by various regulatory agencies and are not in complete agreement on whether a juvenile animal study (JAS) is advisable and its timing and design. This guideline is intended to complement and expand on existing ICH guidelines (e.g., ICH E11, M3,
- [S10](https://aibio.pro/docs/s10/) - PHOTOSAFETY EVALUATION OF PHARMACEUTICALS 1. INTRODUCTION 1.1. Objectives of the Guideline The purpose of this document is to recommend international standards for photosafety assessment, and to harmonise such assessments supporting human clinical trials and marketing authorizations for pharmaceuticals. It includes factors for initiation of and triggers for additional photosafety assessment and should be read in conjunction with ICH M3(R2), Section 14 on Photosafety Testing (Ref. 1). This guideline should reduce the likelihood that substantial differences in recommendations for photosafety assessment will exist among regions. This guideline is divided into several sections. Section 2 discusses factors to consider in any evaluation of photosafety. Section 3 describes existing nonclinical photosafety tests, but this section does not describe specific testing strategies. Section 4 mentions clinical photosafety assessment. Section 5 provides strategies for determining how to assess photosafety for drugs given by routes intended to produce systemic exposure or by the dermal route using the considerations and tests described in Sections 2, 3 and 4. Consideration should be given to the use of non-animal methods or clinical data for photosafety assessment which could reduce the use of animals in accordance with the 3R (Replacement/Reduction/Refinement) principles. 1.2. Background The ICH M3(R2) Guideline provides certain information regarding timing of

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## Product categories

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- [BioMed Linkage](https://aibio.pro/product-category/services/biomed-linkage/) - BioMed Linkage connects global biotech and pharmaceutical companies with top-tier Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) in China. Through our comprehensive network and expertise, we provide tailored, end-to-end solutions that streamline drug development while ensuring quality and compliance. AIBIO AB, as sales representative for BioMed Linkage in Europe, supports clients in Europe by offering seamless access to these advanced services and bridging the gap between global innovation and China’s robust CRO/CDMO ecosystem.
- [Pharmacological Studies](https://aibio.pro/product-category/services/biomed-linkage/pharmacological-studies/) - Pharmacological Studies
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## Docs Categories

- [ICH guidlines](https://aibio.pro/docs-category/ich-guidlines/)
- [Safety Guidelines](https://aibio.pro/docs-category/safety-guidelines/)