Biopharmaceutics and BCS: Future Role in Discovery, Development, and Regulation, as Presented by Dr. Gordon Amidon

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Lecture #31 from the Drug Delivery Foundation's 2010 Oral Drug Delivery Conference: http://www.ddfint.org/previous-events/2017/4/22/odd2010-strategies-for-oral-drug-delivery

Salud y medicina

Gordon L Amidon
College of Pharmacy
University of Michigan
Ann Arbor, MI 48109

 GI Physiology: Transport Mechanistic
 Permeability &Transit
 Physical Chemistry: InVivo Dissolution
 Solubility/Dissolution
 Biopharmaceutical Evaluation: Mechanistic
 InVivo-InVitro
 Dosage FormTechnology: Optimization of Delivery
 IR and MR
 Regulatory Advances: Separate BE and BA Science
 Essential Standard to Insure Label Claims

Efficacy
Safety
Half life
Bioavailability
Dose is actually a surrogate of BA

1970’s
Descriptive
/ Empirical
1980’s
Mechanistic/
Organ
1990’s
Tissue/
Cell
2000’s
Genomic/
Membrane
1960
Biopharmaceutics:
The Beginning

Unknown localization: HPT1, CAT-1, EAAC1, CNT, CNT2, ENT1, ENT2, SAAT1, NBC2,
NPT4, NAPI-3B, SVCT1-2, FAT
Fig. A. Localization of intestinal membrane transporters and their coupling for nutrients and drug absorption. Arrows indicate
the direction of transport. Dashed arrows indicate the coupling of apical transporters with basolateral transporters. rBAT and
b0,+AT form a complex for functional transporter. HLAT and 4F2hc, hy+ LAT and 4F2hc also form a transporter complex.
Apical membraneIntestinal lumen Basal membrane
rBAT
4F2hc
ATB0
TAUT
b0,+AT
hPepT1
MCT1
MOAT
MDR
IBAT
FATP4
SGLT1
GLUT5 GLUT2
OCT1
OCT3
ILBP
HLAT ?
hy+ LAT ?
?
?
?
?

August 2000 FDA Guidance
Amidon et al.., Pharmaceutical Research, 12, 413
(1995).

Biopharmaceutics
History: What
Happened
1960 : Limited Technology
1990: A BA View
2010: Molecular Mechanism

 Mechanistic
 GI Physiology and Product Dissolution
 Focused on Product: BE and labeling
 Dissolution Methodology and BCS InVivo
Relevance
 Mechanistic ADME: BCS and BDDCS

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Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits. To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups. Technology For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did. While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis. Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad. Age and Gender When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same. Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers. Race Affects Attitudes As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).

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The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands. It’s important that you’re ready to implement new strategies in 2024. Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024. You’ll learn: - The latest trends in AI and automation, and what this means for an evolving paid search ecosystem. - New developments in privacy and data regulation. - Emerging ad formats that are expected to make an impact next year. Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape. If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.

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From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world. With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively. The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage. Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience. See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers See the original article on Forbes here: http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b

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Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world. Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance. For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age. Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.

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Biopharmaceutics and BCS: Future Role in Discovery, Development, and Regulation, as Presented by Dr. Gordon Amidon

1. Gordon L Amidon College of Pharmacy University of Michigan Ann Arbor, MI 48109

2.  GI Physiology: Transport Mechanistic  Permeability &Transit  Physical Chemistry: InVivo Dissolution  Solubility/Dissolution  Biopharmaceutical Evaluation: Mechanistic  InVivo-InVitro  Dosage FormTechnology: Optimization of Delivery  IR and MR  Regulatory Advances: Separate BE and BA Science  Essential Standard to Insure Label Claims

3. Efficacy Safety Half life Bioavailability Dose is actually a surrogate of BA

4. 1970’s Descriptive / Empirical 1980’s Mechanistic/ Organ 1990’s Tissue/ Cell 2000’s Genomic/ Membrane 1960 Biopharmaceutics: The Beginning

5. ∫∫∫ ⋅∞= t A effabs CdAdtPMtMF 0 )(/)(

8. Unknown localization: HPT1, CAT-1, EAAC1, CNT, CNT2, ENT1, ENT2, SAAT1, NBC2, NPT4, NAPI-3B, SVCT1-2, FAT Fig. A. Localization of intestinal membrane transporters and their coupling for nutrients and drug absorption. Arrows indicate the direction of transport. Dashed arrows indicate the coupling of apical transporters with basolateral transporters. rBAT and b0,+AT form a complex for functional transporter. HLAT and 4F2hc, hy+ LAT and 4F2hc also form a transporter complex. Apical membraneIntestinal lumen Basal membrane rBAT 4F2hc ATB0 TAUT b0,+AT hPepT1 MCT1 MOAT MDR IBAT FATP4 SGLT1 GLUT5 GLUT2 OCT1 OCT3 ILBP HLAT ? hy+ LAT ? ? ? ? ?

10.

11.

12. Label Product Efficacy & “BE”

13.

14.

15. August 2000 FDA Guidance Amidon et al.., Pharmaceutical Research, 12, 413 (1995).

16. Biopharmaceutics History: What Happened 1960 : Limited Technology 1990: A BA View 2010: Molecular Mechanism

17.

18.  Mechanistic  GI Physiology and Product Dissolution  Focused on Product: BE and labeling  Dissolution Methodology and BCS InVivo Relevance  Mechanistic ADME: BCS and BDDCS

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Biopharmaceutics and BCS: Future Role in Discovery, Development, and Regulation, as Presented by Dr. Gordon Amidon