plants determined using innovative analytical methods; as well as (e) to evaluate the
effects and remediation of drugs in crops and biota.
Keywords ADME, Analytical methods, Crops, Distribution, Drug development,
Drug discovery, Earthworms, Fate, Humans, Metabolism, Soil, Wetlands
1 Introduction
According to the definition of the US Food and Drug Administration (FDA), an
active ingredient is “any component that provides pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body of man or animals.”
1 Within the
realm of the pharmaceutical industry and the regulatory agencies, the terms “active
ingredient,” “pharmaceutically active substance,” and “drug” are used interchangeably with the latter term commonly preferred for the sake of simplicity. Here, for the
remainder of this introductory chapter, the term drug is used, although many
publications in the field of environmental sciences tend to differentiate between
pharmaceutically active compounds (PhACs) on the one hand and drugs in the sense
of illegal or illicit ones on the other hand.
Regarding the above definition, most drugs elicit their pharmacological effect in
the target organism through interactions with specific macromolecular entities which
are involved in physiological processes or signaling cascades. The understanding of
these biological processes at a molecular level allows to design drugs for the
selective modulation of their activity. In view of the broad variety of potential
pharmacological targets comprising enzymes, transmembrane receptors, ion channels, transport proteins, nuclear receptors, protein-protein interfaces, RNA, and
DNA [1], the chemical structures of drug molecules are highly diverse, and after
the dominating role of small-molecule drugs for most of the existence of modern
drug research, novel therapeutic modalities are becoming ever more important,
including monoclonal antibodies, proteins, peptides, and antisense oligonucleotides
[2]. Within the context of environmental studies, though, the focus has been on low
molecular weight compounds (<800–1,000 Da) of well-defined structure that are
accessible through classical organic synthesis or can be isolated, and if needed
chemically modified, with relative ease from naturally occurring microorganisms
(e.g., macrolide antibiotics).
Irrespective of the drug class to aim at, engaging into the business of drug
discovery and development is characterized by a lengthy and tedious process,
tremendous investment, high risk of failure, and uncertainty about the return on
1 https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms
4
N. Montemurro et al.
effects and remediation of drugs in crops and biota.
Keywords ADME, Analytical methods, Crops, Distribution, Drug development,
Drug discovery, Earthworms, Fate, Humans, Metabolism, Soil, Wetlands
1 Introduction
According to the definition of the US Food and Drug Administration (FDA), an
active ingredient is “any component that provides pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body of man or animals.”
1 Within the
realm of the pharmaceutical industry and the regulatory agencies, the terms “active
ingredient,” “pharmaceutically active substance,” and “drug” are used interchangeably with the latter term commonly preferred for the sake of simplicity. Here, for the
remainder of this introductory chapter, the term drug is used, although many
publications in the field of environmental sciences tend to differentiate between
pharmaceutically active compounds (PhACs) on the one hand and drugs in the sense
of illegal or illicit ones on the other hand.
Regarding the above definition, most drugs elicit their pharmacological effect in
the target organism through interactions with specific macromolecular entities which
are involved in physiological processes or signaling cascades. The understanding of
these biological processes at a molecular level allows to design drugs for the
selective modulation of their activity. In view of the broad variety of potential
pharmacological targets comprising enzymes, transmembrane receptors, ion channels, transport proteins, nuclear receptors, protein-protein interfaces, RNA, and
DNA [1], the chemical structures of drug molecules are highly diverse, and after
the dominating role of small-molecule drugs for most of the existence of modern
drug research, novel therapeutic modalities are becoming ever more important,
including monoclonal antibodies, proteins, peptides, and antisense oligonucleotides
[2]. Within the context of environmental studies, though, the focus has been on low
molecular weight compounds (<800–1,000 Da) of well-defined structure that are
accessible through classical organic synthesis or can be isolated, and if needed
chemically modified, with relative ease from naturally occurring microorganisms
(e.g., macrolide antibiotics).
Irrespective of the drug class to aim at, engaging into the business of drug
discovery and development is characterized by a lengthy and tedious process,
tremendous investment, high risk of failure, and uncertainty about the return on
1 https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms
4
N. Montemurro et al.