Research | ABDA

Modelling Bioactivities of Botanical Extracts Using Network Pharmacology and Polypharmacology.

ABSTRACT: Network pharmacology and polypharmacology are emerging as novel drug discovery paradigms. The many discovery, safety and regula...

Botanical drug clinical trial: common issues and future options

ABSTRACT Botanical drugs are plant-derived, complex mixtures which may have synergistic effects. In order to understand this disparity be...

The Development of Botanical Drugs – A Review

Plants for millennia have provided the major source of the medicinal compounds used to treat our illnesses. Until the early 1900’s plant-...

Botanical Drug Development and Quality Standards

The Center for Drug Evaluation and Research (CDER) established the Botanical Review Team in 2003, published a Guidance for Industry: Bota...

EU regulatory and Quality Requirements for Botanical Drugs and Their Implications

European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products devel...

Development and Validation of In-line Near-Infrared Spectroscopy Based Analytical Method

Development and validation of in-line near-infrared spectroscopy based analytical method for commercial production of a botanical drug pr...

Multiple chromatographic fingerprinting and its application to the quality control of herbal medicin

Abstract Recently, chromatographic fingerprinting has become one of the most powerful approaches to quality control of herbal medicines. ...

AUTHENTICATION AND QUALITY ASSESSMENT OF BOTANICALS AND BOTANICAL PRODUCTS USED IN CLINICAL RESEARCH

Abstract: Fundamental in the clinical assessment of herbal drugs is the need for the full characterization of the botanical and/or the bo...

Botanical Drug Development: Waiver of Preclinical Pharm/Tox Studies and Importance of Initial Clinic

Abstract Development of botanical drug products in the U.S. may be entitled for a waiver of preclinical Pharm/Tox (P/T) studies prior to ...

Challenges and recommendations for assessing absorption, distribution, metabolism and excretion

Abstract Botanical dietary supplements are complex mixtures containing one or more botanical ingredient(s), each containing numerous cons...

Botanical New Drugs: From INDs to NDAs

Botanical mixtures, although many widely used around the world for various health care purposes, have, for the most part, not been extens...

Botanicals in Dermatology: Essential Oils, Botanical Allergens, and Current Regulatory Practices

Abstract Largely because of their perceived safety, the use of essential oils and other botanically derived products has become increasin...

Merging Traditional Chinese Medicine with Modern Drug Discovery Technologies to Find Novel Drugs

Traditional Chinese Medicines (TCM) are rapidly gaining attention in the West as sources of new drugs, dietary supplements and functional...

A weighting chromatographic fingerprinting to ensure quality consistency of botanical Product

Abstract The batch-to-batch quality consistency needs to be controlled to ensure the efficacy and safety of botanical drug products. Chro...

Chemometric Analysis for Identification of Botanical Raw Materials for Pharmaceutical Use

Chemometric Analysis for Identification of Botanical Raw Materials for Pharmaceutical Use: A Case Study Using Panax notoginseng Abstract ...

A regulatory science viewpoint on botanical–drug interactions

1. Introduction Botanical product sales and usage have increased steadily over the years driven in part by the perceived safety of natura...

Mass Spectrometry Real-Time Process Monitoring in Botanical Drug Manufacturing

Abstract A promising process analytical technology (PAT) tool has been introduced for batch processes monitoring. Direct analysis in real...

Reverse Pharmacology Applicable for Botanical Drug Development

Ethnopharmacology and Traditional Herbal Medicine Over the past two decades, traditional medicine, now termed “Complementary and Alternat...

Current Regulatory Perspectives on Genotoxicity Testing for Botanical Drug Product Development in US

Abstract Genotoxicity testing is an important part of preclinical safety assessment of new drugs and is required prior to Phase I/II clin...

Drug Development in Oncology: A Regulatory Perspective

Abstract The ultimate goal of any drug development, including that in oncology, is to register the new medicinal product. A number of cha...

Regulatory Toxicology Perspectives on the Development of Botanical Drug Products in the US

Abstract Toxicological studies constitute an essential part of the effort in developing a botanical supplement into a drug product. The U...

Scientific Validation of Herbal Medicine

The value of the herbal medicine market size was USD 71.19 billion globally in 2016 and is expected to grow even more in the near future....

Macro and microscopic evaluation for quality control of raw drug material

Pharmacognostic techniques involving macroscopic, microscopic and also dry powder analysis serve as botanical methods which help in the c...

Role of mass spectrometry in establishing safety and efficacy of botanical dietary supplements

As in drug discovery and development, mass spectrometry has become essential at all stages for establishing the safety and efficacy of bo...

American Botanical Drug Association

Journal is seeking a sponsor to develop

Modelling Bioactivities of Botanical Extracts Using Network Pharmacology and Polypharmacology.

Botanical drug clinical trial: common issues and future options

The Development of Botanical Drugs – A Review

Botanical Drug Development and Quality Standards

EU regulatory and Quality Requirements for Botanical Drugs and Their Implications

Development and Validation of In-line Near-Infrared Spectroscopy Based Analytical Method

Multiple chromatographic fingerprinting and its application to the quality control of herbal medicin

AUTHENTICATION AND QUALITY ASSESSMENT OF BOTANICALS AND BOTANICAL PRODUCTS USED IN CLINICAL RESEARCH

Botanical Drug Development: Waiver of Preclinical Pharm/Tox Studies and Importance of Initial Clinic

Challenges and recommendations for assessing absorption, distribution, metabolism and excretion

Botanical New Drugs: From INDs to NDAs

Botanicals in Dermatology: Essential Oils, Botanical Allergens, and Current Regulatory Practices

Merging Traditional Chinese Medicine with Modern Drug Discovery Technologies to Find Novel Drugs

A weighting chromatographic fingerprinting to ensure quality consistency of botanical Product

Chemometric Analysis for Identification of Botanical Raw Materials for Pharmaceutical Use

A regulatory science viewpoint on botanical–drug interactions

Mass Spectrometry Real-Time Process Monitoring in Botanical Drug Manufacturing

Reverse Pharmacology Applicable for Botanical Drug Development

Current Regulatory Perspectives on Genotoxicity Testing for Botanical Drug Product Development in US

Drug Development in Oncology: A Regulatory Perspective

Regulatory Toxicology Perspectives on the Development of Botanical Drug Products in the US

Scientific Validation of Herbal Medicine

Macro and microscopic evaluation for quality control of raw drug material

Role of mass spectrometry in establishing safety and efficacy of botanical dietary supplements