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Exploring the Intraperitoneal Route in a New Way for Preclinical Testing
The peritoneum serves as the primary site for the spread of most of the intraperitoneal (IP) diseases. The available literature showed that IP drug...
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Indispensable Potency (Biological Activity)
The measurement of potency (strength) is a regulatory requirement for all pharmaceuticals. For chemical drugs, the potency is determined by measuring...
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Downstream Purification of the Biopharmaceutical Drug Substance
The upstream production process has been designed to yield the intended biopharmaceutical. But the upstream design carries with it a complex impurity...
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Biopharmaceutical Critical Quality Attributes
Manufacturers must ensure that the quality of their medicines, both for the drug substance (DS) and for the drug product (DP), meet all of the...
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Complex Process-Related Impurity Profiles
Every manufactured human medicine contains residual impurities associated with its manufacturing process. Patient safety risk associated with the...
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Intraperitoneal Delivery Systems
Intraperitoneal delivery (IPD) has been in practice since the early twentieth century and has since been employed for treating various ailments from...
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Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC): Promising Strides from India
Peritoneal surface oncology (PSO) has progressed by leaps and bounds over more than a decade in India, but PIPAC is still struggling to gain...
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Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
Regulatory compliance is essential for patient protection, and it applies both to Clinical as well as to Chemistry, Manufacturing & Controls (CMC)....
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Starting Materials for Manufacturing the Biopharmaceutical Drug Substance
Starting materials (also referred to as source materials) are the starting point for cGMP manufacturing of the biopharmaceutical drug substance. Some...
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Potentiometry
Potentiometry is the field of electroanalytical chemistry in which potential developed between two electrodes is measured under the conditions of no...
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Refractometry
Electromagnetic radiation has particle nature (i.e. photon concept) and wave nature. The particle nature of electromagnetic radiations is considered...
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Colligative Properties
The word colligative evolved from Latin word “Colligatus” meaning “tied or bound together”. Due to common dependence of four properties i.e. lowering...
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Catalysis
When the addition of a small amount of a chemical substance changes the rate of attainment of chemical equilibrium but the substance itself does not...
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Migrationskontaminanten
Mineralische Kohlenwasserstoffe (MOSH/MOAH) sind in der Umwelt weit verbreitet und können auf unterschiedlichen Wegen in Lebensmittel gelangen. Der...
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Lebensmittelkonservierung
Die industrielle Herstellung der LebensmittelLebensmittelkonservierung bedingt zwangsläufig größere Zeitspannen für die Verteilung an den...
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Insekten als Lebensmittel/Futtermittel
InsektenInsekt sind wirbellose Tiere. Sie gehören zu den Gliederfüßern (Arthropoda). Insekten atmen durch Tracheen, besitzen ein offenes...
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Lebensmittel und Ernährung
Die Ernährung gehört zu den physiologischen Grundbedürfnissen jedes Menschen. Die Zufuhr von Stoffen, die der Ernährung dienen, erfolgt durch...
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Das europäische Lebensmittelrecht
Die schnelle Entwicklung der LebensmittelwirtschaftLebensmittelrecht in der zweiten Hälfte des 19. Jahrhunderts zur Versorgung der rasch wachsenden...
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Pflanzenschutzmittel
Rückstände sind zurückbleibende Reste von Stoffen, die bei der landwirtschaftlichen Erzeugung von Lebensmitteln oder während deren Lagerung...
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Proteinbasierte Lebensmittel
Während im Pflanzenreich Cellulose als Bausubstanz und Stärke als Reservestoff dominieren, enthalten Lebensmittel tierischer Herkunft vorwiegend...